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1.
Fertil Steril ; 45(5): 635-42, 1986 May.
Article in English | MEDLINE | ID: mdl-2938985

ABSTRACT

Blood glucose and pyruvate, plasma insulin, and glucagon levels as well as erythrocyte insulin receptors were measured during an oral glucose tolerance test in 38 normal women before and after 6 months' use of one of three new oral contraceptives containing low doses of 19 nortestosterone-derived progestogens, levonorgestrel, and desogestrel. A slight deterioration of glucose tolerance was observed, with the area under the glucose curve increasing by only 7%, 9%, and 12% after Ovidol (Aaciphar SA, Brussels, Belgium), Marvelon (Organon, SA, Brussels, Belgium), and Trigynon (Schering SA, Brussels, Belgium) administration, respectively. We did not find any argument in favor of the development of a state of insulin resistance in women using these compounds, because erythrocyte receptor binding was not modified and plasma insulin responses to glucose were decreased. The glucose-induced suppression of plasma glucagon levels seemed less effective for treatment with the desogestrel-containing preparations than with the levonorgestrel-containing oral contraceptives.


Subject(s)
Carbohydrate Metabolism , Contraceptives, Oral, Hormonal/adverse effects , Norgestrel/adverse effects , Norpregnenes/adverse effects , Adult , Blood Glucose/metabolism , Contraceptives, Oral, Combined/adverse effects , Desogestrel , Drug Combinations , Erythrocytes/metabolism , Ethinyl Estradiol/adverse effects , Ethinyl Estradiol-Norgestrel Combination , Female , Glucagon/blood , Glucose Tolerance Test , Humans , Insulin/blood , Prospective Studies , Pyruvates/blood , Pyruvic Acid , Random Allocation , Receptor, Insulin/drug effects
2.
Obstet Gynecol Surv ; 45(9): 578-84, 1990 Sep.
Article in English | MEDLINE | ID: mdl-2204850

ABSTRACT

PIP: 5 cases of vascular complications--hemorrhagic stroke, myocardial infarction, retinal vein thrombosis, thrombotic stroke and deep vein thrombosis--in young women taking low dose oral contraceptives are described from the Department of Obstetrics and Gynecology, University of the Witwatersrand, Johannesburg, South Africa. The hemorrhagic stroke occurred in 1987 in a 24-year old heavy smoker taking Triphasil (Wyeth) for 12 months. She recovered fully. A 34-year old woman had an anteroseptal infarction while on Minovlar ED (Schering, 50 mcg ethinyl estradiol and 1 mg norethisterone acetate) for 2 years. She had no risk factors other than smoking 5 cigarettes daily. The woman with retinal vein thrombosis had 2 episodes, the 1st while taking Restovar 28 (Organon, 37.5 mcg ethinyl estradiol and 0.75 mg lynestrenol) for 7 years. 19 months later she began Diane (Schering AG, 50 mcg ethinyl estradiol and 2 mg cyproterone acetate) and had a bilateral retinal vein thrombosis leaving her partially blind. The woman with thrombotic stroke was 24 when she was struck in 1986, after 1 year of taking Logynon ED (Schering AG, 6/5/7 days, 30,40/40 mcg ethinyl estradiol and o.5/0.75/0.125 mg levonorgestrel). The patient with deep vein thrombosis was 19, smoked, and had used Triphasil for 2.5 years.^ieng


Subject(s)
Cardiovascular Diseases/chemically induced , Contraceptives, Oral, Combined/adverse effects , Adult , Cardiovascular Diseases/epidemiology , Causality , Contraceptives, Oral, Combined/classification , Contraceptives, Oral, Combined/supply & distribution , Female , Humans , Incidence
3.
Blood Coagul Fibrinolysis ; 1(6): 647-51, 1990 Dec.
Article in English | MEDLINE | ID: mdl-2133244

ABSTRACT

Heparin cofactor II (HCII) was assayed by a microtitre amidolytic substrate technique. A linear response was obtained up to 1.5 U/ml and HCII levels were not affected by freezing and thawing the plasma. The assay was validated by comparing HCII and antithrombin III (AT III) levels in AT-III-deficient plasmas and samples from critically ill patients. Higher HCII levels were found in healthy normal women than in healthy normal men (means 1.16 and 0.97 U/ml, respectively, P less than 0.01). A significant increase in HCII levels from 0.86 to 1.10 U/ml (mean values) was seen in healthy normal women starting on combined oral contraceptive (COC) preparations (P less than 0.001). Increased HCII levels were maintained over a 6-month period, but fell towards normal 14 days after stopping COC, although they were still significantly higher than before starting COCs. The discrepancy in HCII level between normal men and women may be due to COC use. In clinical studies, different reference ranges should be used for men and women, and the need for careful questioning about the use of COCs is emphasized.


PIP: Heparin cofactor II, a less well characterized heparin-dependent antithrombin factor than antithrombin III, was determined in 11 women before, during and after a 6 month trial of oral contraceptives, in 16 women aged 18-60, in 16 men aged 22-55, in 5 patients with known antithrombin III deficiency, and in a series of 16 patients in a critical care unit. The oral contraceptives used in the trial were Femodene (Schering, Burgess, Hill, U.K.) in 6 women and Marvelon (Organon, Cambridge, U.K.) in 5. The assay was an amidolytic microtiter method standardized against normal human serum. The assay was linear up to 1.5 U/ml, and HCII was not lost by repeated freezing and thawing. HCII levels were normal in patients with AT III deficiency, but ranged from 0.10-1.11 in intensive care patients. In normal subjects the mean HCII levels were 1.07 U/ml, and were significantly higher for women, 1.16, than for men, 0.97 U/ml. During intake of oral contraceptives, HCII rose significantly from 0.86 u/ml to 1.10 at cycle 1, 1.08 at cycle 3, and 1.19 at cycle 6. 2 weeks after stopping pills, the mean HCII level fell to 1.03. In contrast, AT III declined during pill cycles.


Subject(s)
Contraceptives, Oral, Combined/pharmacology , Heparin Cofactor II/analysis , Adolescent , Adult , Antithrombin III/analysis , Antithrombin III Deficiency , Female , Heparin Cofactor II/deficiency , Humans , Male , Middle Aged
4.
Contraception ; 49(1): 33-46, 1994 Jan.
Article in English | MEDLINE | ID: mdl-8137624

ABSTRACT

A comparative study of two low-dose oral contraceptives, gestodene (GES) 75 mcg/ethinyl oestradiol (EE) 30 mcg and desogestrel (DES) 150 mcg/EE 20 mcg, was conducted in women over 30 years of age. This randomised, open-label study was organised in Denmark, Italy, New Zealand and United Kingdom. A total of 505 women received GES/EE and 501 received DES/EE for 6 consecutive menstrual cycles. The two groups were comparable in terms of demographic and gynaecologic characteristics at baseline. However, the menstrual flow length was slightly longer in the GES/EE group before the start of the treatment. The mean age (+/- SD) was 35 +/- 4 years in the GES/EE group and 35 +/- 5 years in the DES/EE group. The subjects in the GES/EE group contributed data for a total of 2800 cycles and those in the DES/EE group, data for 2796 cycles. There were no pregnancies on medication with either preparation. The results showed that there were significantly more normal cycles in the GES/EE group for cycles 1 to 6. Irregular bleeding between withdrawal bleeds occurred in 10% of GES/EE and 18.5% of DES/EE cycles. Absence of all bleeding was reported in 29 (1%) and 63 (2%) cycles, respectively. The incidence of missed pills was low in both groups (11% of cycles). No significant differences were observed in cycle length or withdrawal bleeding episode length. Withdrawal bleeding mean intensity was statistically significantly greater with GES/EE. However, for both preparations, the mean intensity was close to light bleeding. No clinically significant differences were noted in weight, blood pressure, Papanicolaou smears or laboratory data. Sixty-eight (13.5%) subjects in the GES/EE group and 64 (12.8%) in the DES/EE group discontinued before the end of the study. Among them, 37 (7%) and 40 (8%) in the respective groups withdrew because of adverse reactions. There was no difference between groups in terms of primary reasons for withdrawal. The most frequently reported complaints that led to discontinuation in both groups were headache, nausea and metrorrhagia. Breast tenderness led to the discontinuation of 1 subject in the GES/EE group and 3 in the DES/EE group. These results show excellent cycle control, efficacy and very low rate of side effects with both GES/EE and DES/EE. These low-dose oral contraceptives could be well suited to healthy nonsmoking women requiring contraception up to the age of menopause.


PIP: At 66 sites in Denmark, Italy, New Zealand, and the UK, clinicians randomly allocated 1006 women 30 years old, some of whom were in their early 50s, into 1 of 2 groups receiving a low-dose oral contraceptive (OC): Minulet containing 75 mcg gestodene (GES)/30 mcg ethinyl estradiol (EE) and Mercilon containing 150 mcg desogestrel (DES)/20 mcg EE. The study aimed to compare these 2 low-dose OCs to help physicians prescribe an OC that could be continued into later years. Before treatment, the 2 groups had similar demographic and gynecologic characteristics. The mean menstrual flow length in the GES/EE group was longer than that of the DES/EE group (4.7 days vs. 4.5 days; p = .035) though. None of the women during 2800 cycles of GES/EE use and 2796 cycles of DES/EE use conceived, even though women forgot to take at least 1 pill in 11% of cycles. The GES/EE OC had significantly better cycle control than did the DES/EE OC. For example, the GES/EE group was more likely to have normal cycles than the DES/EE group (84-93% vs. 73-83%; p .001). The DES/EE group experienced a significantly lower withdrawal bleeding mean intensity than the GES/EE group in all 6 cycles, but the bleeding for both groups was close to light bleeding. The 2 groups were similar in weight, blood pressure, Papanicolaou smears, and laboratory data. Discontinuation rates for the GES/EE and DES/EE groups were 13.5% and 12.8%, respectively. Adverse reactions accounted for discontinuation in 7% of the GES/EE group and 8% of the DES/EE group. The major complaints leading to discontinuation were headache, nausea, and breakthrough bleeding. Both GES/EE and DES/EE had very good cycle control and efficacy and a very low rate of side effects. These results suggest that both these low-dose OCs would be acceptable for healthy nonsmoking women needing contraception up to menopause.


Subject(s)
Ethinyl Estradiol/administration & dosage , Norpregnenes/administration & dosage , Pancuronium/analogs & derivatives , Adult , Contraceptives, Oral, Combined/administration & dosage , Contraceptives, Oral, Combined/adverse effects , Denmark , Ethinyl Estradiol/adverse effects , Female , Humans , Italy , Middle Aged , New Zealand , Norpregnenes/adverse effects , Pancuronium/administration & dosage , Pancuronium/adverse effects , United Kingdom
5.
Contraception ; 53(3): 171-6, 1996 Mar.
Article in English | MEDLINE | ID: mdl-8689882

ABSTRACT

The aim of the present study was to compare changes in the endogenous androgen environment in healthy women while on low-dose oral contraceptives (OCs). One-hundred healthy women were randomized to receive one of four OCs during six months: 21 tablets of Cilest, Femodeen, Marvelon, or Mercilon. During the luteal phase of the pretreatment cycle, body weight and blood pressure were recorded and the following parameters were measured: sex hormone-binding globulin (SHBG), corticosteroid-binding globulin (CBG), testosterone (T), free testosterone (FT), 5 alpha-dihydrotestosterone (DHT), androstenedione (A), dehydroepiandrosterone-sulphate (DHEA-S) and 17 alpha-hydroxyprogesterone (170HP) while also the free androgen index (FAI) was calculated. Measurements were repeated during the 3rd week of pill intake in the 4th and the 6th pill month. There were no differences on body mass and blood pressure with the use of the four OCs. The mean serum DHEA-S decreased significantly in all groups though less in the Mercilon group when compared to Cilest and Marvelon (approximately 20% vs 45%). Mean serum SHBG and CBG increased significantly in all four groups approximately 250% and 100%, respectively. In each group CBG also increased significantly but less in women taking Mercilon (-75%) as compared to the others (-100%). Current low-dose OCs were found to have similar impact on the endogenous androgen metabolism with significant decreases of serum testosterone, DHT, A, and DHEA-S. They may be equally beneficial in women with androgen related syndromes such as acne and hirsutism.


PIP: Health researchers randomly assigned 100 healthy women aged 18-38 from the Netherlands and Saudi Arabia to one of four various oral contraceptive (OC) groups to undergo six cycles of OC therapy so they could evaluate changes in plasma concentrations of sex hormone binding globulin (SHBG), corticosteroid-binding globulin (CBG), albumin (Alb), testosterone (T), free testosterone (FT), dihydrotestosterone (DHT), androstenedione (A), dehydro-epiandrosterone-sulphate (DHEA-S), and 17 alpha-hydroxyprogesterone (17OHP). The four monophasic OCs were Cilest (35 mcg ethinyl estradiol [E2] and 250 mcg norgestimate), Femodeen (30 mcg E2 and 75 mcg gestodene), Marvelon (30 mcg E2 and 150 mcg desogestrel), and Mercilon (20 mcg E2 and 150 mcg desogestrel). There were 12 dropouts. Neither body weight nor blood pressure changed significantly during the study. All steroidal serum parameters (T, FT, DHT, A, DHEA-S, 17OHP, Alb) fell significantly during the six cycles of OC treatment (ratio of decrease, 1.3-3), regardless of OC type. These changes had appeared after cycle 4. The only significant difference between the OC groups was that the mean decrease of DHEA-S for Mercilon was lower than that for the other OC groups (21% vs. 43% for Cilest, 44% for Marvelon, and 34% for Femodeen; p 0.05). SHBG and CBG rose greatly during OC use in all four OC groups (mean increase = 263% and 94%, respectively; p 0.05). The increase in CBG was significantly less in the Mercilon group than in the other OC groups (74% vs. 96% for Cilest, 101% for Femodeen, and 102% for Marvelon; p 0.05). These findings show that OC use changed the endogenous androgen environment in the direction of hypoandrogenism. Thus, all four OCs can equally treat androgen-related syndromes (e.g., acne and hirsutism).


Subject(s)
Androgens/blood , Contraceptives, Oral, Combined/administration & dosage , Contraceptives, Oral, Combined/adverse effects , Ethinyl Estradiol-Norgestrel Combination/analogs & derivatives , 17-alpha-Hydroxyprogesterone , Adolescent , Adult , Androstenedione/blood , Dehydroepiandrosterone/analogs & derivatives , Dehydroepiandrosterone/blood , Dehydroepiandrosterone Sulfate , Desogestrel/administration & dosage , Desogestrel/adverse effects , Dihydrotestosterone/blood , Drug Combinations , Ethinyl Estradiol/administration & dosage , Ethinyl Estradiol/adverse effects , Female , Humans , Hydroxyprogesterones/blood , Luteal Phase , Norgestrel/administration & dosage , Norgestrel/adverse effects , Norgestrel/analogs & derivatives , Norpregnenes/administration & dosage , Norpregnenes/adverse effects , Pancuronium/administration & dosage , Pancuronium/adverse effects , Pancuronium/analogs & derivatives , Progestins/administration & dosage , Progestins/adverse effects , Sex Hormone-Binding Globulin/metabolism , Testosterone/blood , Transcortin/metabolism
6.
Contraception ; 45(6): 523-32, 1992 Jun.
Article in English | MEDLINE | ID: mdl-1535580

ABSTRACT

A randomised cross-over trial was performed to compare the pharmacodynamic actions of three low-dose oral contraceptives (OCs): Marvelon (150 micrograms desogestrel (DSG)+ 30 micrograms ethinyloestradiol (EE)), Mercilon (150 micrograms DSG + 20 micrograms EE) and Microgynon (150 micrograms levonorgestrel (LNG) + 30 micrograms EE). None of the OCs produced any significant changes in serum cholesterol, LDL-C and apoprotein B. Triglycerides were increased by the desogestrel OCs but not by Microgynon. The latter however increased the glucose and insulin responses to a glucose tolerance test whereas Marvelon and Mercilon had no effect. HDL-C increased with Marvelon, was unchanged with Mercilon and was decreased with Microgynon. Apoprotein AII was increased by all three OCs but only the DSG OCs increased apoprotein AI. All OCs produced similar increases in caeruloplasmin but the increase in SHBG was much greater with Marvelon and Mercilon than with Microgynon. Testosterone was reduced more with Microgynon than with the DSG OCs. Many of the changes reflect the strong anti-oestrogenic action of LNG on metabolic parameters compared to DSG. Except for the effect on HDL-C, there was little difference between Marvelon and Mercilon on metabolic parameters and this complements the findings from large-scale clinical trials of the two OCs. Mercilon, therefore provides a very satisfactory alternative to Marvelon.


PIP: 12 healthy volunteers attending the family planning clinic at Shanghai, First Maternity and Infant China, Hospital, enrolled in the study, Oral contraceptives (OCs) were prescribed: Marvelon (150 mcg of desogestrel--DSG), Mercilon (150 mcg of DSG), and Microgynon (150 mcg of levonorgestrel--LNG). The patients were divided into 6 groups of 2 persons each in a randomized cross-over study. OCs were taken on day 6 of the cycle up to day 21, then stopping for 7 days. Each OC was used for 3 months. During the pretreatment cycle between days 6 and 9 of the follicular phase and 21 and 22 of the luteal phase a blood sample was taken after fasting for determination of lipids, sex hormone binding globulin (SHGB), ceruloplasmin, and testosterone. After glucose loading, significant increases of glucose and insulin occurred at 1, 2, and 3 hours during treatment with Microgynon only. The ratio for total areas of insulin to glucose did not change significantly nor did glycosilated hemoglobin A1 levels. Serum triglyceride concentrations increased significantly for both Marvelon (27%-43%) and Mercilon (29-40%). Serum high density lipoprotein (HDL) cholesterol concentrations were significantly elevated with Marvelon but less so with Mercilon, while HDL-C decreased significantly with Microgynon. The serum low density lipoprotein (LDL) cholesterol changes were not significant, but LDL-C concentrations declined with DSG formulations and increased with Microgynon. Apoprotein A1 and A2 increased significantly for both Marvelon and Mercilon. Apoprotein A2 increased with Microgynon. Serum SHBG increased markedly with Marvelon (335-380%). Serum testosterone concentrations decreased significantly (33.2-40.4% with Microgynon) and so did ceruloplasmin values. The antiestrogenic effect of strong LNG in Microgynon produced significant metabolic changes. The effect of 30 mcg EE in Marvelon and 20 mcg EE of Mercilon was equal.


Subject(s)
Blood Glucose/metabolism , Contraceptives, Oral, Combined , Ethinyl Estradiol , Insulin/blood , Levonorgestrel , Lipids/blood , Norgestrel , Norpregnenes , Pancuronium/analogs & derivatives , Progesterone Congeners , Adult , Apolipoproteins/blood , Ceruloplasmin/analysis , Cholesterol/blood , Desogestrel , Ethinyl Estradiol-Norgestrel Combination , Female , Glucose Tolerance Test , Humans , Sex Hormone-Binding Globulin/analysis , Testosterone/blood , Triglycerides/blood
7.
Contraception ; 59(4): 237-43, 1999 Apr.
Article in English | MEDLINE | ID: mdl-10457868

ABSTRACT

This study was performed to evaluate pituitary-ovarian recovery in the pill-free interval during use of three low-dose combined oral contraceptives (COC). Either the estrogen component or the progestin component was comparable in the study groups, to evaluate their relative influence. Serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol (E2) levels were measured and follicle number and size estimated by transvaginal sonography daily during the 7-day pill-free interval in 44 healthy volunteers using three different low-dose oral contraceptives. Healthy volunteers were enrolled using 20 micrograms ethinyl estradiol (EE) + 75 micrograms gestodene (GSD) (Harmonet, Wyeth-Lederle; n = 15), 20 micrograms EE + 150 micrograms desogestrel (DSG) (Mercilon, Organon n = 17), or 30 micrograms EE + 150 micrograms DSG (Marvelon, Organon, n = 12) given according to the usual regimen of one tablet daily during 3 weeks and 1 week pill-free interval. No ovulations were observed. Pituitary hormones were not statistically significantly different at the beginning of the pill-free interval between the study groups. FSH concentrations were significantly higher at the end of the pill-free interval in the 30 micrograms EE group compared with both 20 micrograms EE groups (7.0 [0.6-12.4] IU/L vs 4.9 [1.4-6.1] IU/L and 4.5 [2.4-7.4] IU/L; p = 0.001). In both 20 micrograms EE groups, a single persistent follicle (24 and 28 mm) was present in one subject. Follicle diameters were statistically significantly smaller at the beginning and at the end of the pill-free period in the 30 micrograms EE group compared with both 20 micrograms EE study groups. Dominant follicles (defined as follicle diameter > or = 10 mm) were observed at the end of the pill-free interval in both 20 micrograms EE groups (in 27% and 18% of women, respectively) but not in the 30 micrograms EE group. Finally, the area-under-the-curve for E2 was statistically significantly lower in the 30 micrograms EE group compared with both 20 micrograms EE groups. In conclusion, the EE content rather than the progestin component in the studied COC determined the extent of residual ovarian activity at the beginning of the pill-free interval. Dominant follicles were encountered only in the 20 micrograms EE study groups.


PIP: This article reports on a study that evaluated pituitary-ovarian recovery in the pill-free interval during a period of use of one of three low-dose combined oral contraceptives (COC). 44 female volunteers using low-dose oral contraception were subdivided into three groups in this comparative study: 15 women used 20 mcg ethinyl estradiol (EE) + 75 mcg gestodene; 17 used 20 mcg EE + 150 mcg desogestrel; 12 used 30 mcg EE + 150 mcg desogestrel. No ovulations were observed. Pituitary hormone levels between the study groups were not significantly different at the beginning of the pill-free interval. Follicle-stimulating hormone (FSH) concentrations were significantly higher at the end of the pill-free interval in the 30 mcg EE group than in both 20 mcg EE groups. In each of the 20 mcg EE groups, a single persistent follicle (24 mm and 28 mm, respectively) was found in 1 subject. In conclusion, the EE content rather than the progestin component in the studied COC determined the extent of residual ovarian activity at the beginning of the pill-free interval.


Subject(s)
Contraceptives, Oral, Combined/administration & dosage , Ovary/physiology , Pituitary Gland/physiology , Adolescent , Adult , Contraceptives, Oral, Synthetic/administration & dosage , Desogestrel/administration & dosage , Estradiol/blood , Ethinyl Estradiol/administration & dosage , Female , Follicle Stimulating Hormone/blood , Humans , Luteinizing Hormone/blood , Norpregnenes/administration & dosage , Ovarian Follicle/anatomy & histology
8.
Contraception ; 56(1): 23-30, 1997 Jul.
Article in English | MEDLINE | ID: mdl-9306028

ABSTRACT

In a double-blind randomized study, the suppression of ovarian activity and anti-conceptive effects on the cervix and endometrium were assessed during administration of two low-dose monophasic oral contraceptives (20 micrograms ethinyl estradiol [EE], 500 micrograms norethisterone--Eve 20 [Grünenthal, Aachen, Germany]; 20 micrograms EE, 150 micrograms desogestrel --Lovelle [Organon, Munich, Germany]). One hundred eighteen healthy women (ages: 18-35 years) were studied in 10 investigation centers during medication with either Eve 20 (n = 59) or Lovelle (n = 59). During three treatment cycles, ovarian activity was evaluated by sonographic determination of follicle-like structures (FLS) and by simultaneous assessment of serum endocrine profiles (gonadotropins LH and FSH, ovarian steroids estradiol [E2] and progesterone [P]). While on either treatment, no ovarian activity (as judged by no FLS and/or reduced sex steroid levels) was found in 90.8% (Eve 20) and 97.2% (Lovelle) of all investigated cycles. Follicular activity or cyst formation were detected in 18 of 173 cycles (Eve 20) and in 5 of 175 cycles (Lovelle), respectively. Gonadotropin levels were suppressed (LH < 6 IU/L, FSH < 8 IU/L) in most treatment cycles (Eve 20 76.6% vs. Lovelle: 84.8%). Serum E2 concentrations exceeding 0.1 nmol/L indicated residual follicular activity in 19.3% (Eve 20) versus 12.2% (Lovelle) of all cycles. An estimated by serum P levels over 5 nmol/L, ovulation had presumably occurred in 4.1% (Eve 20) versus 2.9% (Lovelle) of treatment cycles. However, when the sonographical and endocrinological data were combined, no ovulation was documented in any pill cycle. The quality and quantity of the cervical mucus was found to be minimal in the majority of women. Moreover, the endometrial layer was determined to be low by ultrasound during most pill cycles, indicating equally strong suppressive effects on endometrial receptivity by the two contraceptives. These observations suggest that ovarian activity is suppressed in the majority of cycles during use of low-dose contraceptives. This effect may mainly be medicated by pronounced suppression of serum gonadotropin levels. Strong anti-conceptive effects of these formulations on both cervical permeability and endometrial receptivity are additional factors ensuring the contraceptive efficacy of these formulations.


PIP: The impact of two low-dose monophasic oral contraceptives (OCs) on suppression of ovarian activity, cervical permeability, and endometrial receptivity was investigated in a randomized double-blind study involving 118 healthy women 18-35 years of age recruited from 10 study centers in Germany. 59 women received Eve (20 mcg of ethinyl estradiol and 500 mcg of norethisterone) and 59 were given Lovelle (20 mcg of ethinyl estradiol and 150 mcg of desogestrel) for a total of 3 cycles. No ovarian activity, as assessed by sonographic determinations of follicle-like structures and serum endocrine profiles, was detected in 90.8% of cycles of Eve users and 97.2% of cycles in the Lovelle group. Follicular activity or cyst formation was found in 18 of 173 cycles of Eve users and 5 of 175 cycles of Lovelle users. Gonadotropin levels were suppressed (luteinizing hormone under 6 IU/L and follicle-stimulating hormone less than 8 IU/L) in 76.6% of treatment cycles in the Eve group and 84.8% of cycles in the Lovelle group. Serum estradiol concentrations exceeding 0.1 nmol/L, indicative of follicular activity, were recorded in 19.3% of cycles of Eve users and 12.2% of cycles in the Lovelle group. Although serum progesterone levels were over 5 nmol/L in 4.1% of cycles in the Eve group and 2.9% of those in the Lovelle group, consolidation of sonographic and endocrinologic data failed to document ovulation in any treatment cycles. The quantity and quality of cervical mucus was minimal in most women in both groups. Finally, the endometrial layer was determined to be low by ultrasonography during most pill cycles, confirming the OCs' equally strong suppressive effects on endometrial receptivity.


Subject(s)
Cervix Mucus/drug effects , Contraceptives, Oral, Combined/pharmacology , Contraceptives, Oral, Synthetic/pharmacology , Endometrium/drug effects , Ovary/drug effects , Adult , Cervix Mucus/physiology , Cohort Studies , Desogestrel/pharmacology , Double-Blind Method , Estradiol/blood , Estradiol/metabolism , Ethinyl Estradiol/pharmacology , Female , Follicle Stimulating Hormone/blood , Follicle Stimulating Hormone/metabolism , Gonadotropins/blood , Gonadotropins/metabolism , Humans , Luteinizing Hormone/blood , Luteinizing Hormone/metabolism , Menstrual Cycle/drug effects , Menstrual Cycle/physiology , Norethindrone/pharmacology , Ovary/diagnostic imaging , Ovary/physiology , Progesterone/blood , Progesterone/metabolism , Steroids/blood , Steroids/metabolism , Ultrasonography
9.
Arch Oral Biol ; 36(7): 549-52, 1991.
Article in English | MEDLINE | ID: mdl-1837983

ABSTRACT

The composition and flow rate of paraffin-stimulated whole saliva were analysed in 22 women, of whom 11 used oral contraceptives and 11 did not. Ten men served as the controls. The salivary samples were collected during one month (oral contraceptive users and men), or during one menstrual cycle (non-users). The saliva analyses included flow rate, pH, buffer effect, sialic acid, thiocyanate, peroxidase, lysozyme, amylase, immunoglobulins A, G and M, total protein, mutans streptococci, lactobacilli, yeasts and total numbers of aerobic bacteria. The salivary buffer effect of oral contraceptive users was significantly (p less than 0.005) higher than that of non-users. All the other constituents showed intra- and interindividual variation in all groups, but with no apparent hormone-dependency.


PIP: The flow rate and composition of whole saliva were analyzed in 11 women using low dose oral contraceptives in comparison with 11 menstruating women and 10 men. Paraffin-stimulated whole saliva samples were collected Monday, Wednesday and Friday mornings for 1 cycle or 1 month in all subjects, checked for pH and buffer effect (Dentobuff method, Orion Diagnostics, Espoo, Finland, a measure of bicarbonate content) immediately, and frozen for later assay of salivary lysozyme, amylase, peroxidase, thiocyanate, sialic acid, total protein, IgA, IgG, IgM, Mutans streptococci, Lactobacilli, yeasts and aerobic bacteria. The oral contraceptives taken were Marvelon (Organon, Holland) by 4 subjects, Microgynon (Leiras, Finland) by 1, and Trikvilar (Leiras) by 6. The only significant differences between subject groups of cycle phases was a higher salivary buffer effect in oral contraceptive users than that seen in non-users, who resembled male controls. There was a wide individual variation in most values, but less variation in pH and buffer effect. Salivary buffer effect, which is correlated with HCO3-content and salivary flow, is also higher in late pregnancy.


Subject(s)
Contraceptives, Oral/pharmacology , Saliva/drug effects , Adult , Buffers , Contraceptives, Oral/administration & dosage , Contraceptives, Oral, Combined , Contraceptives, Oral, Hormonal/administration & dosage , Contraceptives, Oral, Hormonal/pharmacology , Contraceptives, Oral, Synthetic/administration & dosage , Contraceptives, Oral, Synthetic/pharmacology , Desogestrel , Drug Combinations , Ethinyl Estradiol/administration & dosage , Ethinyl Estradiol/pharmacology , Ethinyl Estradiol-Norgestrel Combination , Female , Humans , Levonorgestrel/administration & dosage , Levonorgestrel/pharmacology , Male , Menstrual Cycle , Menstruation , Norgestrel/administration & dosage , Norgestrel/pharmacology , Norpregnenes/administration & dosage , Norpregnenes/pharmacology , Ovulation , Progesterone Congeners/administration & dosage , Progesterone Congeners/pharmacology , Saliva/chemistry , Saliva/metabolism , Salivary Proteins and Peptides/analysis , Salivary Proteins and Peptides/drug effects
10.
Contraception ; 82(3): 276-80, 2010 Sep.
Article in English | MEDLINE | ID: mdl-20705157

ABSTRACT

BACKGROUND: This randomized study's aim was to compare the effect of four oral contraceptives (OCs) containing 30 mcg of ethinylestradiol (EE) and different progestogens [drospirenone, (DRSP), chlormadinone acetate (CMA), desogestrel (DSG), gestodene (GSD)] on biochemical and hormonal parameters of hyperandrogenism and sex hormone-binding globulin (SHBG) in women with polycystic ovary syndrome (PCOS). STUDY DESIGN: Forty women with PCOS (age 16-35 years) were recruited and randomly assigned to one of four treatment groups of 10 women each, treated, respectively, with 3 mg DRSP/30 mcg EE (Yasmin, Bayer Shering), 2 mg CMA/30 mcg EE (Belara, Grunenthal), 75 mcg GSD/30 mcg EE (Minulet, Wyeth Lederle) and 150 mcg DSG/30 mcg EE (Practil 21, Organon Italia). Blood samples were obtained on day 6-8 of the control cycle and day 6-8 of the third treatment cycle for assay of the following hormones: androsteredione (A), total testosterone (T), free T, SHBG, dehydroepiandrosterone sulphate (DHEAS). RESULTS: In all groups, mean concentrations of free T, total T and A dropped by 40-60%, and concentrations of DHEAS dropped by 20-50%. Formulations with DRSP and CMA caused a greater reduction of androgens and a progressive increase in serum concentrations of SHBG than those with DSG and GSD. CONCLUSIONS: Clinical studies need to be performed to determine effects of these OCs upon clinical signs of hyperandrogenism.


Subject(s)
Contraceptives, Oral, Combined/pharmacology , Ethinyl Estradiol/pharmacology , Hyperandrogenism/blood , Polycystic Ovary Syndrome/blood , Polycystic Ovary Syndrome/drug therapy , Progesterone Congeners/pharmacology , Sex Hormone-Binding Globulin/metabolism , Adolescent , Adult , Androstenedione/blood , Androstenes/pharmacology , Chlormadinone Acetate/pharmacology , Dehydroepiandrosterone Sulfate/blood , Desogestrel/pharmacology , Female , Humans , Norpregnenes/pharmacology , Sex Hormone-Binding Globulin/analysis , Statistics, Nonparametric , Testosterone/blood , Young Adult
12.
Fertil Steril ; 85(1): 57-62, 2006 Jan.
Article in English | MEDLINE | ID: mdl-16412731

ABSTRACT

OBJECTIVE: To compare uterine tissue concentrations of ethinyl estradiol (EE) and etonogestrel (ENG) after one cycle of use of a contraceptive vaginal ring (NuvaRing; NV Organon, Oss, The Netherlands) or a combined oral contraceptive (COC). DESIGN: Randomized, open-label, pharmacokinetic study. SETTING: Obstetrics and gynecology unit. PATIENT(S): Eight premenopausal women about to undergo hysterectomy but otherwise healthy. INTERVENTION(S): One cycle (17-21 days) of NuvaRing or COC treatment that ended with surgical hysterectomy. MAIN OUTCOME MEASURE(S): Tissue concentrations of EE and ENG in uterine tissue samples taken from the upper myometrium and mid-myometrium, the cervical region, and the endometrium. RESULT(S): In both groups, concentrations of EE and ENG were similar in uterine tissue taken from the upper myometrium and mid-myometrium and the cervical region. However, compared with the COC group, concentrations of both hormones were markedly lower in tissue samples from the endometrium of women who had been treated with NuvaRing. CONCLUSION(S): Vaginal administration of hormones with NuvaRing did not produce elevated uterine concentrations of EE and ENG, compared with an oral contraceptive.


Subject(s)
Contraceptive Devices, Female , Contraceptives, Oral, Combined/pharmacokinetics , Desogestrel/pharmacokinetics , Estrogens/pharmacokinetics , Ethinyl Estradiol/pharmacokinetics , Administration, Intravaginal , Adult , Contraceptives, Oral, Combined/administration & dosage , Contraceptives, Oral, Combined/blood , Desogestrel/administration & dosage , Desogestrel/blood , Estrogens/administration & dosage , Estrogens/blood , Ethinyl Estradiol/administration & dosage , Ethinyl Estradiol/blood , Female , Humans , Hysterectomy , Middle Aged , Progesterone Congeners/administration & dosage , Progesterone Congeners/blood , Progesterone Congeners/pharmacokinetics , Tissue Distribution , Uterus/surgery
13.
Br J Obstet Gynaecol ; 100(9): 832-8, 1993 Sep.
Article in English | MEDLINE | ID: mdl-8218004

ABSTRACT

OBJECTIVE: To compare two oral contraceptive pills, both containing 150 micrograms desogestrel, but with either 20 micrograms (Mercilon) or 30 micrograms (Marvelon/Desolett) ethinyl oestradiol (EE), regarding reliability, cycle control and side effect profile. DESIGN: A double blind, randomised, multicentre study over one year with follow up after three, six and 12 months. The women noted tablet intake and all bleedings on specifically designed diary cards. SETTING: University clinics, central hospitals and private gynaecological practices in Norway, Sweden and Denmark. SUBJECTS: One thousand women aged 18 to 40 years requesting oral contraceptive pills. MAIN OUTCOME MEASURES: Reliability, cycle control, side effects, blood pressure, body weight and haemoglobin. RESULTS: In a total of 4543 cycles with the 20 micrograms EE dose pill and 4688 cycles with the 30 micrograms EE dose pill, the number of pregnancies ascribed to method failure were 0 and 2, respectively. Irregular bleeding (break-through bleeding or spotting) was significantly more frequent with the 150/20 combination in about two-thirds of the cycles randomly distributed over the one year of the study. Mean blood pressure decreased slightly, particularly in the group on the 150/20 combination (about 1 mmHg), whereas mean body weight increased approximately 0.5 kg in the group with the 150/30 combination after 12 months. Haemoglobin did not change. Side effects other than bleeding problems were rare, but dizziness and mood changes were more frequent in the group on the 150/20 combination. Due to side effects, more women on the 150/20 combination discontinued the study during the one to three and four to six month periods, and women on this pill were also less positive about continuing the study drug at the end of the trial. CONCLUSIONS: Both pills have high contraceptive reliability and are well tolerated, but with the 150/20 combination the cycle control is less effective. However, in view of the potentially increased safety profile of the 150/20 combination, many women can be expected to accept some additional discomfort due to irregular bleeding.


PIP: A double-blind, randomized, multicenter study compared 2 combined oral contraceptives containing 150 mcg desogestrel and either 30 mcg (Marvelon/Desolett) or 20 mcg (Mercilon) of ethinyl estradiol, focusing on reliable pregnancy prevention and cycle control. The women were 300 Norwegians, 500 Swedes, and 200 Danes, 52% of whom switched from a prior brand of pill. Women completed bleeding diaries: all bleeding that did not start in the 7-day tablet-free interval and last for 7 or fewer days was considered irregular bleeding, either breakthrough bleeding or spotting. The 2 groups were similar except that those taking the 150/20 combination were slightly older. There were 2 pregnancies with the 20 mcg combination and 3 with the 30 mcg pill, 2 of which were considered method failures. In 8573 cycles analyzed there were more instances of irregular bleeding and amenorrhea with the 20 mcg pill than with the 30 mcg pill. Duration of breakthrough bleeding was not significantly different. Irregular bleeding was also more common n women switching from another brand of pill to a lower estrogen dose pill. Blood pressure decreased slightly on the 20 mcg ill and body weight rose slightly on the 30 mcg pill, but hemoglobin did not change. More women dropped out or chose not to continue taking the 150/20 mcg pill because of side effects, usually irregular bleeding, mood changes, dizziness, or weight gain. Despite these differences, there were enough women who tolerated the lower dose combination pill to merit continuing to take it.


Subject(s)
Contraceptives, Oral, Combined/administration & dosage , Desogestrel/administration & dosage , Ethinyl Estradiol/administration & dosage , Menstrual Cycle/drug effects , Pancuronium/analogs & derivatives , Adolescent , Adult , Body Weight , Chemistry, Pharmaceutical , Contraceptives, Oral, Combined/adverse effects , Contraceptives, Oral, Combined/chemistry , Desogestrel/adverse effects , Double-Blind Method , Female , Humans , Pancuronium/administration & dosage , Pancuronium/adverse effects , Risk Factors
14.
Homeopath Fr ; 73(5): 299-305, 1985.
Article in French | MEDLINE | ID: mdl-12281246

ABSTRACT

PIP: This work describes a study of the effects of combined oral contraceptives (OCs) on lipid biosynthesis in platelets of female rats and women. A highly significant hypercoagulability due solely to increased activity of platelet factor 3 can be observed in women using combined OCs. The phospholipidic nature of factor 3 has been demonstrated. Phospholipids are implicated in the aggregation of platelets because they are the essential constituents of the platelet membranes and the precursors of prostaglandins. Platelets actively synthesize their own lipids, and combined OCs modify serum lipid metabolism. In each experiment, a control group of rats weighing 180-200 g received .5 ml/g body weight of olive oil once daily for 4 days. 3 groups of experimental rats received .5 ml of olive oil containing 10 mcg of ethinyl estradiol (EE) and 250 mcg of lynestrenol or 10 mcg of EE alone or 250 mcg of lynestrenol alone per 100 g of body weight. The doses were the equivalent of 1/2 that required to block ovulation in adult female rats. Platelets were studied on the 5th day. In another experiment a group of rats was given a triple dose of EE and lynestrenol on the 1st study day. Platelets were studied on days 1, 3, 5, and 8. Lipid biosynthesis was studied by incorporation of carbon 14 labelled acetate and mevalonate precursors. Radioactivity was measured for the lipids as a whole and for different lipid fractions separated by chromatography. Incorporation of carbon 14 labelled acetate was augmented by 44.6% in animals receiving EE and lynestrenol and by 43% in animals receiving EE alone, but was not modified in animals receiving lynestrenol alone. In animals receiving a triple dose of hormones, incorporation was maximal on the 3rd day, diminished on the 5th day, and normal after 8 days. The EE component thus appears to be responsible for modifications in platelet lipid metabolism during OC use. The response appears after a latency period and seems to be irreversible, since the duration of life of platelets is 4-5 days. The increased synthesis occurs mainly in cholesterol and its precursors lanosterol and dihydrolanosterol. Supplemental in vitro experiments suggested that lanosterol was responsible for the increased platelet activity. 17 nonsmoking women aged 32 years on average who took no medications were compared to 18 women aged 30 years on average who took OCs with estrogen doses of 30-40 mcg for at least 6 months. As in the rat studies, lipid biosynthesis was analyzed by incorporation of carbon 14 labelled acetate or mevalonate in the platelets. Compared to control women, the women on OCs showed an augmentation of 37% in incorporation of mevalonate and 28% of acetate. The labelled acetate showed a higher incorporation at the level of each of the lipid fractions. Mevalonate showed the highest augmentation in the lanosterol fraction. 43% of the women taking OCs showed an increased platelet sensitivity to thrombine. The increased sensitivity was correlated with increased lanosterol synthesis, but the relation was only observed in women taking OCs. The phenomenon is of interest because of its possible relationship to the increased risk of thromboembolic accidents in women taking OCs.^ieng


Subject(s)
Blood Coagulation , Blood , Cholesterol , Contraception , Contraceptive Agents, Female , Contraceptives, Oral, Combined , Contraceptives, Oral , Disease , Family Planning Services , Lipids , Metabolism , Organic Chemicals , Platelet Aggregation , Research , Biology , Cardiovascular System , Cerebrovascular Circulation , Chemical Phenomena , Chemistry , Contraceptive Agents , Economics , In Vitro Techniques , Physiology , Technology , Thromboembolism , Thrombosis , Vascular Diseases
15.
Integration ; (32): 16-8, 1992 Jun.
Article in English | MEDLINE | ID: mdl-12285550

ABSTRACT

PIP: The Turkish Family Health and Planning Foundation initiated the commercial marketing of contraceptives in 1989 as part of a Contraceptive Social Marketing (CSM) program to make available low-cost contraceptives. In 1988 modern methods were used by 31% and traditional methods by 32.3%, while 36.6% used no contraceptives. Only 6.2% were current pill users mainly because of health reasons since high-dose pills dominated the market. A 1990 survey among urban consumers indicated a 94% awareness of contraceptive methods, 76.1% of current use, and preference for the IUD. The side effects of the pill were cited for disliking it, and the condom was rated higher. The CSM project aims at popularizing low-dose pills by explaining the differences and benefits regarding high-dose pills. It collaborated with manufacturers: Schering, Wyeth, Organon, and Eczacibasi Ilac. In 1991 a TV and radio advertisement campaign started that involves the low-dose products Microgynon, Triquilar, Desolet, Lo-Ovral, and Tri-Nordial. The introduction of the Okey condom by Eczacibasi Ilac. In June 1991 also entailed extensive promotion with newspaper ads and TV spots after getting official permission. 1.3 million condoms were sold in the 1st 2 months in 13,000 retail outlets, and 4 million more were projected to be sold. A shift of the attitude of supermarket owners allowing stocking of condoms and the support of the Turkish Ministry of Health, USAID, and the Turkish Radio and Television Bureau has facilitated the CSM project implementation that will profoundly affect family planning in Turkey.^ieng


Subject(s)
Advertising , Condoms , Contraceptives, Oral, Combined , Contraceptives, Oral , Intrauterine Devices , Marketing of Health Services , Newspapers as Topic , Radio , Television , Asia , Asia, Western , Communication , Contraception , Developing Countries , Economics , Family Planning Services , Mass Media , Turkey
16.
Eur J Contracept Reprod Health Care ; 5(1): 25-34, 2000 Mar.
Article in English | MEDLINE | ID: mdl-10836660

ABSTRACT

OBJECTIVE: To assess the contraceptive reliability, cycle control and tolerability of a new monophasic oral contraceptive containing 30 g ethinylestradiol plus 3 mg drospirenone (Yasmin, Schering AG, Berlin, Germany), it was compared with an established oral contraceptive containing 30 g ethinylestradiol plus 150 g desogestrel (Marvelon, NV Organon, Oss, The Netherlands). METHODS: A randomized, open-label, 13-cycle study was performed at 80 European centers. Contraceptive reliability, cycle control, blood pressure, body weight, the incidence of adverse events and skin condition were assessed during 13 cycles of oral contraceptive use, and at follow-up. Subjects recorded body weight on three consecutive days pretreatment and weekly thereafter. RESULTS: Of 2069 women who started the study and received the trial preparations in a ratio of 4:1 (ethinylestradiol/drospirenone, n = 1657; ethinylestradiol/desogestrel, n = 412), 1615 completed the 13 cycles plus follow-up, providing data for over 23,000 evaluable cycles. Eleven pregnancies occurred during treatment, only one of which (in the ethinylestradiol/drospirenone group) could not be ascribed to user failure or interaction with other factors. Both preparations provided effective contraception and cycle control. Pre-existing acne and seborrhea were improved and blood pressure was essentially unchanged. The two treatments differed in their effect on body weight, the difference being statistically significant. In the ethinylestradiol/drospirenone group, there was a distinct decrease over the whole treatment phase, while a subtle and less distinct decrease was documented in the ethinylestradiol/desogestrel group. CONCLUSIONS: The combination of 30 g ethinylestradiol/3 mg drospirenone provides effective oral contraception, excellent cycle control, good tolerability and a level of weight loss that may have a significant beneficial effect on compliance in women with a tendency to weight gain due to water retention.


Subject(s)
Androstenes/pharmacology , Contraceptives, Oral, Combined/pharmacology , Estradiol Congeners/pharmacology , Ethinyl Estradiol/pharmacology , Menstrual Cycle/drug effects , Mineralocorticoid Receptor Antagonists/pharmacology , Progesterone Congeners/pharmacology , Adolescent , Adult , Androstenes/adverse effects , Contraceptives, Oral, Combined/adverse effects , Estradiol Congeners/adverse effects , Ethinyl Estradiol/adverse effects , Europe , Female , Humans , Mineralocorticoid Receptor Antagonists/adverse effects , Progesterone Congeners/adverse effects , Skin/drug effects , Weight Gain/drug effects
17.
Contracept Deliv Syst ; 5(2): 97-104, 1984 Apr.
Article in English | MEDLINE | ID: mdl-12266201

ABSTRACT

PIP: A combined oral contraceptive (OC, Restovar, Organon) containing 0.0375 mg ethinyl estradiol and 0.75 mg lynestrenol was investigated. Various clinical and laboratory variables were studied in 164 women over 1376 treatment cycles. No pregnancies occurred. In common with other low-dose combined preparations, Restovar also caused some intermenstrual bleeding but acceptability was good in the majority of women. The frequency of general complaints was low. The estrogen-sensitive proteins, ceruloplasmin and transcortin, increased in proportion to the estrogen content of the preparation. The estrogen-androgen-sensitive proteins, sex hormone binding globulin, and thyroxin binding globulin, increased to a rather high level. Free testosterone decreased significantly. The elevation of sex hormone binding globulin level was accompanied by a decrease in free testosterone. The strong increases in sex hormone binding globulin and thyroxin binding globulin indicate that the preparation has a very low androgenic activity. The latter was confirmed in 2 women with initially low sex hormone binding globulin levels who showed a marked improvement in hirsutism and acne during treatment; this improvement was correlated with an increase in sex hormone binding globulin and decreased free testosterone levels.^ieng


Subject(s)
Androgens , Blood Proteins , Blood , Clinical Laboratory Techniques , Contraception , Contraceptive Agents, Female , Contraceptives, Oral, Combined , Contraceptives, Oral , Diagnosis , Disease , Evaluation Studies as Topic , Hormones , Research Design , Testosterone , Acne Vulgaris , Biology , Body Weight , Contraceptive Agents , Dihydrotestosterone , Endocrine System , Ethinyl Estradiol , Family Planning Services , Hirsutism , Lynestrenol , Physiology , Pregnancy , Pregnancy Rate , Reproduction , Research , Skin
18.
Acta Obstet Gynecol Scand ; 69(1): 61-5, 1990.
Article in English | MEDLINE | ID: mdl-2140663

ABSTRACT

An open, randomized, multicenter study was carried out to compare two oral contraceptives as regards their therapeutic efficacy in androgenization symptoms such as acne, seborrhea and hirsutism in women. The preparations used were the combination of 2 mg cyproterone acetate (CPA) with 0.035 mg ethinyl estradiol (EE) (Diane 35, Schering AG, Berlin-West) and 0.150 mg desogestrel (DG) with 0.03 mg ethinyl estradiol (Marvelon, Organon, Oss, The Netherlands). The duration of therapy was 9 months. The combination of CPA-EE was used by 83 patients for 658 cycles and the combination of DG-EE by 79 women for 618 cycles. No pregnancy occurred under either therapy. Both preparations are well tolerated. However, some side-effects, such as reduced libido, nervousness and breast tenderness, were observed more frequently (p less than 0.05) in the DG-EE group than among the users of the CPA-EE combination. The therapeutic outcome was better in the CPA-EE group, especially in cases of facial acne (p less than 0.05). Seborrheic symptoms also responded better to the CPA-EE therapy. The results show that the CPA-EE combination is superior to the DG-EE combination in the treatment of acne and seborrhoea.


Subject(s)
Acne Vulgaris/drug therapy , Contraceptives, Oral, Combined/pharmacology , Cyproterone/analogs & derivatives , Cyproterone/pharmacology , Dermatitis, Seborrheic/drug therapy , Hirsutism/drug therapy , Norpregnenes/pharmacology , Adult , Breast/drug effects , Cyproterone/adverse effects , Cyproterone Acetate , Desogestrel , Female , Humans , Multicenter Studies as Topic , Norpregnenes/adverse effects , Randomized Controlled Trials as Topic
19.
Eur J Contracept Reprod Health Care ; 9(3): 131-40, 2004 Sep.
Article in English | MEDLINE | ID: mdl-15697102

ABSTRACT

OBJECTIVES: To compare carbohydrate metabolism, adrenal and thyroid function during use of a combined contraceptive vaginal ring (NuvaRing, NV Organon, Oss, The Netherlands) with those of a combined oral contraceptive. METHODS: Healthy women aged 18-40 years used either the vaginal ring, delivering 15 microg ethinylestradiol and 120 microg of etonogestrel per day, or a combined oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel, for six cycles. Each cycle comprised 3 weeks of use of the ring or the pill followed by 1 ring- or pill-free week. The following parameters were measured at baseline and at the end of cycles 3 and 6: carbohydrate metabolism (glucose, insulin, glycosylated hemoglobin); adrenal function (total cortisol, cortisol binding globulin, dehydroepiandrosterone sulfate); thyroid function (thyroid stimulating hormone, free thyroxine). RESULTS: Small and similar increases in insulin were seen in both groups. Concentrations of cortisol binding globulin and total cortisol rose significantly less during ring use than during combined oral contraceptive use (cycle 3, p= 0.0002; cycle 6, p < 0.0001). Levels of dehydroepiandrosterone sulfate did not change in either group. Thyroid stimulating hormone levels increased significantly more in the ring group at cycle 3 (p = 0.0016) but free thyroxine levels were unchanged in both groups. CONCLUSIONS: Both the vaginal ring and the oral contraceptive have no clinically relevant effects on carbohydrate metabolism, adrenal or thyroid function.


Subject(s)
Blood Glucose/drug effects , Contraceptive Devices, Female , Contraceptives, Oral, Combined/pharmacology , Ethinyl Estradiol/pharmacology , Levonorgestrel/pharmacology , Adolescent , Adrenal Glands/drug effects , Adult , Blood Glucose/metabolism , Carrier Proteins/blood , Carrier Proteins/drug effects , Contraceptives, Oral, Combined/administration & dosage , Dehydroepiandrosterone Sulfate/blood , Drug Administration Schedule , England , Ethinyl Estradiol/administration & dosage , Female , Glycated Hemoglobin/drug effects , Glycated Hemoglobin/metabolism , Humans , Hydrocortisone/blood , Insulin/blood , Levonorgestrel/administration & dosage , Netherlands , Scotland , Thyroid Gland/drug effects , Thyrotropin/blood , Thyrotropin/drug effects , Thyroxine/blood , Thyroxine/drug effects , Treatment Outcome
20.
Am J Obstet Gynecol ; 186(3): 389-95, 2002 Mar.
Article in English | MEDLINE | ID: mdl-11904596

ABSTRACT

OBJECTIVE: The purpose of this study was to compare cycle control and tolerability of the NuvaRing (NV Organon, Oss, The Netherlands), a novel combined contraceptive vaginal ring, with a standard combined oral contraceptive pill. STUDY DESIGN: Healthy women aged 18 to 40 years who requested contraception received either NuvaRing or a combined oral contraceptive containing 30 microg ethinyl estradiol and 150 microg levonorgestrel for 6 cycles in 3 similarly designed studies. Each cycle comprised 3 weeks of ring or pill use, followed by 1 ring- or pill-free week. RESULTS: Two hundred forty-seven women began the studies, 121 women with NuvaRing and 126 women with the combined oral contraceptive. Withdrawal bleeding occurred in virtually all cycles in both groups. In the NuvaRing groups, the incidence of irregular bleeding was < or =5% in all cycles; this was lower than the combined oral contraceptive groups (5.4%-38.8%). Furthermore, the incidence of a normal intended bleeding pattern was significantly higher in the NuvaRing groups than in the combined oral contraceptive groups (P <.01). Both contraceptives were well tolerated. CONCLUSION: NuvaRing has excellent cycle control and is well tolerated.


Subject(s)
Contraceptive Agents, Female/administration & dosage , Contraceptive Devices, Female , Estradiol Congeners/administration & dosage , Ethinyl Estradiol/administration & dosage , Levonorgestrel/administration & dosage , Menstrual Cycle/drug effects , Administration, Oral , Adult , Contraceptive Agents, Female/adverse effects , Contraceptive Agents, Female/pharmacology , Contraceptive Devices, Female/adverse effects , Contraceptives, Oral, Combined/therapeutic use , Drug Combinations , Estradiol Congeners/adverse effects , Estradiol Congeners/pharmacology , Ethinyl Estradiol/adverse effects , Ethinyl Estradiol/pharmacology , Female , Humans , Incidence , Levonorgestrel/adverse effects , Levonorgestrel/pharmacology , Uterine Hemorrhage/chemically induced , Uterine Hemorrhage/epidemiology , Uterine Hemorrhage/etiology , Uterine Hemorrhage/physiopathology
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