ESC expert statement on the effects on mood of the natural cycle and progestin-only contraceptives.

Hormonal fluctuations during the natural cycle, as well as progestins used for hormonal contraception, can exert effects on mood especially in vulnerable women. Negative effects of levonorgestrel-releasing intrauterine contraception on mood are rare.

Contraception after breast cancer: a retrospective review of the practice among French gynecologists in the 2000's.

PURPOSE OF INVESTIGATION: To describe the French practices regarding contraception after breast cancer in the 2000's. MATERIALS AND METHODS: A total of 2,500 forms were sent to gynecologists practicing in France. Inclusion criteria were premenopausal patients who had a history of breast cancer and who had been prescribed contraception after diagnosis. Between June 1, 2002 and January 1, 2003, 197 evaluable responses were retrieved. RESULTS: The median age of the sample was 38.5 years. The most commonly used form of contraception was an intrauterine device (n = 144, 73.1%). Hormonal contraception was prescribed for 42 patients (21.3%), and other methods were used in 29 patients (14.7%) (Condoms n = 14, tubal sterilization n = 7, and others n = 8). Recurrence occurred in 27 patients (13%); 2.9% in the progestin group, 16.3% in the IUD group, and 14.8% with the other methods). CONCLUSIONS: It is necessary to evaluate current contraception practices after breast cancer to evaluate the efficacy and safety of contraception in these patients.

Comparison of a 24-day and a 21-day pill regimen for the novel combined oral contraceptive, nomegestrol acetate and 17ß-estradiol (NOMAC/E2): a double-blind, randomized study.

BACKGROUND Nomegestrol acetate/17ß-estradiol (NOMAC/E(2)) is a new monophasic oral contraceptive combining NOMAC (2.5 mg), a highly selective progesterone-derived progestogen, with E(2) (1.5 mg), which is structurally identical to endogenous estrogen. The objective of this study was to compare the effects on ovarian activity of two different NOMAC/E(2) regimens. METHODS This was a double-blind, randomized study. Healthy, premenopausal women (aged 18-38 years, previous menstrual cycle length 28 ± 7 days) were randomized by computer-generated code to once-daily NOMAC/E(2) for three consecutive 28-day cycles: either 24 days with a 4-day placebo interval (n = 40) or 21 days with a 7-day placebo interval (n = 37) per cycle. Follicular growth (primary outcome measure), plasma hormone profiles and bleeding patterns were assessed. RESULTS There was no evidence of ovulation during treatment with either NOMAC/E(2) regimen. The largest follicle diameter was significantly smaller in the 24-day group than in the 21-day group [mean (SD) mm in cycle 2: 9.0 (3.0) versus 11.3 (5.3) (P = 0.02); in cycle 3: 9.2 (3.0) versus 11.5 (6.0) (P = 0.04)]. Mean FSH plasma levels were significantly lower in the 24-day versus the 21-day group on Day 24 of cycles 1 and 2. Withdrawal bleeding duration was significantly shorter in the 24-day than in the 21-day group [mean (SD) days after cycle 1: 3.5 (1.3) versus 5.0 (2.6) (P = 0.002); after cycle 2: 3.9 (1.6) versus 4.8 (1.7) (P = 0.03)]. CONCLUSIONS The 24-day NOMAC/E(2) regimen was associated with greater inhibition of follicular growth and shorter duration of withdrawal bleeding than the 21-day regimen, suggesting the shorter pill-free interval results in a greater margin of contraceptive efficacy and tolerability, and fewer withdrawal symptoms.

Update on the contraceptive contraindications.

BACKGROUND: The choice of contraceptive methods has considerably increased over recent years. However, all available methods are not appropriate for all women, especially those with medical conditions or individual characteristics in whom any pregnancy, particularly unintended pregnancy, is at higher risk. The safety of contraception is crucial for these women and evidence-based guidance to help healthcare providers choosing a suitable method has been published. The aim of our review is to make an update on the main contraceptive contraindications. METHODS: The World Health Organisation Medical Eligibility Criteria for Contraceptive Use (WHO-MEC) published in 2015 are referred to throughout this review. The rationale behind the recommendations for women with cardiovascular, rheumatic, neurologic, gynaecological or endocrine disorders was first analysed. The national adaptations of the WHO-MEC, especially the French, British, and American ones, were then scrutinized. MAIN FINDINGS: Overall, the MECs considered tend to provide the same recommendations. However, there are some noticeable differences that may be useful to know. Hence, for a given condition, differences in categorisation have been noticed where limited or controversial scientific evidence relating to this condition exists, especially regarding hormonal contraceptives. Some medical conditions or characteristics, included in some MECs but not in others, have also been identified. CONCLUSION: MECs represent valuable tools to help clinicians to prescribe the most acceptable and safe contraceptive method for each individual woman. Although it may be useful to consult different MECs for some complex conditions, prescribers should always bear in mind that these MECs are only guidelines and that their clinical judgment should always prevail.

[Contraception during perimenopause: The spermicides option]. / Contraception des femmes en périménopause : place des spermicides.

AIM: In perimenopause, the increased cardiovascular and cancer risk and the increased incidence of gynaecologic disorders have a major impact on the choice of an appropriate contraceptive method. The aim of this review is to assess the potential benefit of spermicides at this stage of woman's life. MATERIALS AND METHODS: This review presents the eligibility criteria of the different contraceptive methods according to national and international guidelines, together with a literature review of the efficacy and side-effects of the two major spermicidal preparations, benzalkonium chloride and nonoxynol-9, with specific focus on the over-40 age group. RESULTS: The guidelines do not contraindicate any contraceptive method in women after 40. The efficacy data of spermicides show high variation between publications, with no age-specific differences. A special group suitable for spermicide use for contraception is perimenopausal women, particularly those with contraindications to other contraceptive methods or unwilling to use them. An additional benefit of some spermicides could be their lubricant effect. CONCLUSION: The spermicide option should be included into contraceptive counselling for women aged over 40, with evidence-based information about their mechanism of action, efficacy and safety. There is, however, a need for efficacy and acceptability studies on spermicides, with special reference to this age group.

[Contraception in breastfeeding women: place for spermicides]. / Contraception des femmes allaitantes: place des spermicides.

Any contraceptive method prescribed to a breastfeeding woman should be not only adapted to her physiological condition after delivery and to the health of her newborn, but should also meet her expectations. According to the French guidelines, combined hormonal contraception is prohibited up to 6 weeks after delivery in breastfeeding women and is not recommended within 6 months. Intrauterine devices and oral progestin alone may be utilized only from the fourth week after delivery. Spermicides have a privileged indication in breastfeeding women. Indeed, they have no restriction in national and international guidelines. In France, spermicides primarily include myristalkonium chloride and benzalkonium chloride that does not pass into maternal milk according Liebert. In addition to their safe use, the lubricant effect of some specialties can be useful. Spermicides can be used in combination with a condom as well as with the lactational amenorrhea method. The acceptability and success of spermicides in breastfeeding woman depends largely on the information of users, their motivation and understanding of the conditions of use.

Oral contraceptive compliance during adolescence.

PIP: A review of the available literature suggests that adolescent lack of compliance with oral contraceptives (OCs) is a multifactorial problem that requires a multifactorial solution. Because of their lack of experience with contraception, higher frequency of intercourse, higher intrinsic fertility, and pattern of frequent stopping or switching of methods, adolescents experience higher OC failure rates than do adult women. Adolescents also are more likely to forget to take the pill or to discontinue due to side effects, without consulting their physician. A survey of European young women identified contraceptive protection without weight gain as the most necessary change in OCs. Adolescents must be counseled not to miss a single pill, observe the pill-free interval, take phasic formulations in the right order, and use a back-up method in case of diarrhea and vomiting or when certain medications (e.g., antibiotics and anti-epileptics) are used concurrently, and be informed of steps to take in the event of side effects and unprotected intercourse. The quality of the counseling appears to be more important to compliance than the quantity of information provided. Pharmacists should complete the counseling initiated by the physician and explain prescription use. The most significant predictor of consistent OC use is the adolescent's motivation.^ieng

[Compliance with hormone replacement therapy in menopause: effect of an original education program. The COMET study]. / Observance du traitement hormonal substitutif de la ménopause: effet d'un programme d'éducation original. L'étude COMET.

OBJECTIVE: To study the impact of an original education program on compliance to hormone replacement therapy (HRT) in post-menopausal women. METHODS: Data were obtained from 1,192 post-menopausal women (age: 53 +/- 5 years) included in the study with an onset less than six months: E2 gel (n = 791) or patch (n = 401) + progestins, and randomized in either educational program (Ep = 600) or regular verbal counselling (VC = 592). A patient is considered bad compliant with HRT when she prematurely stopped the study, whatever the reason of the cessation. The groups EP and VC are homogeneous for the age distribution, the HRT regimen, the date of onset and the climateric symptoms scores. RESULTS: There is a significant difference between EP and VC groups in compliance, respectively 86 and 81% (p < 0.027). This difference is partially explained by the significant improvement in the patch subgroups (EP: 86% versus VC: 77%, p = 0.028). The trend observed in the gel group is not significant (EP: 85% and VC: 82%) due to the high level of compliance usually noticed in women treated with the gel and the verbal counselling. The significative difference in the compliance observed during the verbal counselling between the continuous (76%) and the sequential (86%, p = 0.001) HRT regimen disappears with the educational program (continuous: 84% and sequential: 87%, NS). CONCLUSION: This first large study on the HRT compliance in France, using a patient educational material, validates its efficacy to reach a better compliance than with regular verbal counselling. Even though in the daily practice, about 40% of the patients discontinue the treatment during the first year, 81% of the women followed in this study continue to receive the HRT after nine months of use. The original educational program of the COMET study improves significatively this high compliance (+ 5% from the verbal counselling). Thus, the combination of the doctor verbal counselling and an educational material is desirable to obtain a good compliance with HRT.

[Compliance with hormone replacement therapy in menopausal women: results of a two-year prospective French study comparing transdermal treatment with fixed oral combination therapy]. / Observance du traitement hormonal substitutif de la ménopause: résultats d'une étude prospective française de deux ans, comparant un traitement transdermique et une association fixe par voie orale.

OBJECTIVES: To evaluate rates of continuation with hormone replacement therapy (HRT) at 2 years in 2 cohorts of female patients, one of which was treated with a set combination of oral oestradiol valerate and medroxyprogesterone acetate and the other with percutaneous 17 beta-oestradiol gel combined with an oral progestogen selected by the prescribing doctor. PATIENTS AND METHODS: A prospective, randomised, open study, including 885 patients followed for 2 years whose 477 were in the oral HRT cohort and 408 were in the dermal cohort. Randomisation was done by group with prescription of the selected HRT for the cohort. The 2 treatment groups were compared using chi(2) tests and Fisher's exact test for qualitative variables, Student's t test or Wilcoxon's test for qualitative variables and Kaplan-Meier survival curves for continuation of HRT, with comparisons using the log-rank test. The prognostic value of baseline parameters on subsequent continuation of HRT was studied using the Cox model (Wald test, odds ratio). RESULTS; Among the 885 treated patients, 711 received the HRT assigned to their cohort (382 in the oral HRT cohort, 329 in the dermal HRT cohort). After 2 years, 77.9% of the patients in the oral HRT cohort and 73.4% of the patients in the dermal HRT cohort were continuing to take their prescribed HRT (P = 0. 076): 37.9% of patients in the oral HRT cohort and 20.2% of patients in the dermal HRT cohort (P < 0.001) continued taking their treatment without any modification. CONCLUSION: Although there was no significant difference in the level of compliance in the 2 groups, it is nonetheless worth noting that the HRT compliance with a sequential fixed estroprogestogen combination was, in this trial, at least equal to that with the free combination of a transdermal estrogen and a progestogen whose nature, dosage and sequence duration are selected by the prescriber. On the other hand, treatment modifications occurred more frequently in the cutaneous HRT group, which is logical as free combination affords to adapt the treatment to each patient.

[Male hypogonadotropic hypogonadism. Success of treatment of sterility with HMG plus HCG]. / Hypogonadisme hypogonadotrope masculin. Succès du traitement de la stérilité par HMG + HCG

Ten typical cases of male eunuchoidism (two with anosmia) are reported. After administration of clomifene citrate to five patients, there is no change in blood levels of gonadotrophins in four cases; in the fifth, a small and transitory increase of LH is noted. The intravenous injection of LHRH (100 mug) to five patients induces an increase of serum LH in all cases and serum FSH in three cases. The initial site of the dysfunction is possibly hypothalamic with secondary gonadotrophic pituitary insufficiency. Among six patients anxious for paternity, prolonged treatment (for 36 to 98 weeks), with HCG (250-1 000 I.U. daily) +HMG (65-120 I.U. FSH daily) results in appearance of spermatozoa in the seminal fluid in five cases and a pregnancy was obtained in four cases. Comments are done upon methods of treatment.

[Male hypogonadotrophic hypogonadism: successful treatment of infertility with HMG + HCG (author's transl)]. / Hypogonadisme hypogonadotrope masculin: succès du traitement de la stérilité par H.M.G. + H.C.G

Ten typical cases of male eunuchoidism (two with anosmia) are reported. After administration of clomifene citrate to five patients there was no change in blood levels of gonadotrophins in four cases; in the fifth, a small and transitory increase of LH was noted. The intravenous injection of LHRH (100 mcg) to five patients induced an increase of serum LH in all cases and serum FSH in three cases. The initial site of the dysfunction is possibly hypothalamic with secondary gonadotrophic pituitary insufficiency. Among six patients desiring paternity, prolonged treatment (for 36 to 98 weeks), with HCG(1700-7000 I.U. weekly) + HMG (450-825 I.U. FSG weekly) resulted in the appearance of spermatozoa in the seminal fluid in five cases and a pregnancy was obtained in four cases. Methods of treatment are discussed.

[A microbiological study of swabs taken laparoscopically in cases of salpingitis and tubal sterility. Research for Chlamydia trachomatis and for mycoplasmas (author's transl)]. / Etude microbiologique des prélèvements coelioscopiques dans les annexites et les stérilités tubaires. Recherche de Chlamydia trachomatis et de mycoplasmes.

Research was made for chlamydia trachomatis and ureaplasma urealyticum in the peritoneum and the tubes of 99 women divided into 4 groups: 17 of them were being investigated because of acute salpingitis (Group A), 17 were being investigated for tubal sterility with chronic inflammation diagnosed laparoscopically (Group B), 29 were being investigated for tubal sterility without any laparoscopic evidence of inflammation (Group C) and 36 women had absolutely normal pelves and were being investigated for sterility. These were the control group (D). Swabs were also taken from the lower genital tracts as well as serological tests for chlamydia trachomatis and cytological samplings of the fluid from the Pouch of Douglas and the histology of the tubes. In the 17 women who had acute salpingitis the swabs 4 cases of C.T. and 4 of U.U. In the 46 women who had tubal sterility the laparoscopic swabs showed cases of C.T. and 7 of U.U. The swabs were most often positive in Group B. This group is characterised by a special appearence of the inflammation, with fluid present and viscous adhesions as well as peritoneal inflammatory cysts. These altogether help to make a presumptive diagnosis of C.T. infection on laparoscopy. In the control group of 36 cases there was no sign of C.T. in any case, although 2 swabs from the peritoneum showed U.U. So there is a statistically significant difference between the groups that were suspicious and the control group whether the results were obtained by cultures or by serological diagnosis. On the other hand there is no definitive difference as far as U.U. is concerned. These observations, which are similar to those published by other authors, lead us to think that micro-organisms and especially chlamydia trachomatis could be the bacteriological agent responsible for chronic inflammatory states found so frequently in women with tubal sterility.

[RU 486: current and potential indications. Great expectations and strong resistance]. / RU 486: indications actuelles et potentielles. Riches promesses et vives résistances.

RU 486 is the code name for mifepristone, a 19-norsteroid first synthesized in 1980. Its chemical structure is similar to progesterone and progesterone derivatives. The difference lies in an 11 beta ring substitution which results in high affinity for progesterone and cortisol receptors. Once linked to the receptor, RU 486 temporarily blocks the action of the corresponding hormone. In vitro and in vivo, RU 486 has a powerful anti-progesterone and anti-glucocorticoid effect and a less powerful but nevertheless important anti-androgen effect. The essential clinical application for RU 486 involves its anti-progesterone effect, currently used in several indications including voluntary pregnancy termination and preparation for the prostaglandin action used to induce labour in interrupted pregnancies. Potential indications have been suggested for preparing the cervix for endo-uterine manoeuvres, induction of labour in term pregnancy and contraception. Other potential indications in gynaecology include breast cancer, endometriosis and uterine fibroma. Meningioma and Cushing's syndrome would be further indications. How far will we go with RU 486? All will depend on the social and economic resistance to the drug and to an even greater extent on ethical considerations. The strength of the anti-RU 486 lobby may well dampen the development of non-contraception indications for this effective anti-progesterone agent.

[Incidence of biological intravascular coagulation in legal induced abortions]. / Incidence des coagulations intravasculaires biologiques au cours des interruptions volontaires de grossesse.

A prospective study was designed to evaluate coagulation abnormalities induced by early abortion (before ten weeks of pregnancy). Fifty-two women underwent suction abortion, under diazepam-fentanyl anaesthesia with spontaneous ventilation; they were screened for coagulation parameters before and after surgery. Eight tests were carried out: prothrombin time, activated partial thromboplastin time (APTT), thrombin time platelet count, fibrinogen levels, fibrin split products, fibrin soluble complexes and euglobulin lysis time. Results were consistent with activation. Consequences were limited and one general test (APTT) was not significantly modified. Suction abortion, even performed in early pregnancy, exposed to biological disseminated intravascular coagulation with a general risk of venous thrombosis.

PIP: A prospective study was designed to evaluate coagulation abnormalities induced by early abortion (before 10 weeks of pregnancy). 52 women underwent suction abortion, under diazepam--fentanyl anesthesia with spontaneous ventilation; they were screened for coagulation parameters before and after surgery. 8 tests were carried out: prothrombin time, activated partial thromboplastin time (APTT), thrombin time platelet count, fibrinogen levels, fibrin split products, fibrin soluble complexes and euglobulin lysis time. Results were consistent with activation. Consequences were limited and 1 general test (APTT) was not significantly modified. Suction abortion, even performed in early pregnancy, exposed the patient to biologically disseminated intravascular coagulation with a general risk of venous thrombosis. (author's modified)

[Vaginal and intrauterine contraception]. / Contraception vaginale et intra-utérine.

Vaginal contraception (condom, diaphragm and spermicide in pessary, tablet, jelly, cream, or sponge form) have been little used in France and generally in Europe since the advent of modern contraception with "the pill" and the intrauterine contraceptive device. The former methods, when properly used, are nevertheless both effective and useful, at least as interim measures. In addition, the protection they afford against sexually transmitted diseases and, for the condom, against HIV, is not negligible. Finally, the "barrier" methods of contraception such as the diaphragm and the condom afford significant protection against cancer of the cervix. The intrauterine contraceptive device (IUCD), used in France by 14% of women between 15 and 49 years of age and by 90 million women throughout the world for whom it is the main reversible means of contraception, have a mechanism of action that is still not fully understood. Most IUCD now used are made of copper. There are also diffusion IUCD based on progesterone or a synthetic progestational hormone which are useful in case of anaemia, menorrhagia or dysmenorrhea.

PIP: With the introduction of modern contraceptives (i.e., oral contraceptives and IUDs), women in France as well as those in Europe in general tend not to use vaginal contraceptives as their principal contraceptive method. Vaginal contraceptives include the condom, diaphragm, and spermicide in the form of a pessary, tablet, jelly, cream, or sponge. When vaginal contraceptives are used correctly, they have an acceptable efficacy and are useful, at least as interim methods. It is important to also consider their part in protecting against sexually transmitted diseases and HIV. Further, the vaginal barrier methods, the condom and the diaphragm, provide significant protection against cervical cancer. 14% of women aged 15-49 in France and 90 million women worldwide use the IUD. Worldwide, the IUD is the primary reversible contraceptive method used. The contraceptive mode of action of the IUD is not yet clearly understood. The most popular IUD is the copper-releasing IUD. The IUD releasing progesterone or a synthetic progestin is useful in treating anemia, menorrhagia, or dysmenorrhea.