Further results on the risk of nonfatal venous thromboembolism in users of the contraceptive transdermal patch compared to users of oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol.

CONTEXT: In 2006, we published a study that indicated that the new transdermal contraceptive patch containing ethinyl estradiol (EE) and the progestin norelgestromin did not increase the risk for venous thromboembolism (VTE) compared to oral contraceptive containing norgestimate and 35 microg of EE. OBJECTIVE: This report updates information on the risk of nonfatal VTE in women using the contraceptive patch in comparison to women using oral contraceptives containing norgestimate (either monophasic or triphasic) and 35 microg of EE (norgestimate-35) using an additional 17 months of data. DESIGN, SETTING AND PARTICIPANTS: Nested case-control design based on information from PharMetrics, a US-based company that collects and organizes information on claims paid by managed care plans. The study was nested among all women, aged 15 to 44 years, who started either the contraceptive patch or norgestimate-35 after April 1, 2002. Cases were women with current use of one of these two study drugs and a documented diagnosis of VTE in the absence of identifiable clinical risk factors (idiopathic VTE) who were not in the earlier study. Up to four controls were matched to each case by age and calendar time. MAIN OUTCOME MEASURES: Odds ratios (ORs) comparing the risk of nonfatal VTE in new users of the two contraceptives. RESULTS: We identified 56 new cases of newly diagnosed, idiopathic VTE in the updated study population. The OR comparing the contraceptive patch to norgestimate-35 was 1.1 (95% CI 0.6-2.1). CONCLUSIONS: After evaluating an additional 17 months of data, the results indicate that the risk of nonfatal VTE for the contraceptive patch is closely similar to the risk for oral contraceptives containing 35 mug of EE and norgestimate.

[Emergency contraception: a simple, safe, effective and economical method for preventing undesired pregnancy]. / Anticoncepción de emergencia: un método simple, seguro, efectivo y económico para prevenir embarazos no deseados.

In the following article, the most recent knowledge on emergency contraception (EC) is reviewed. EC is defined as those contraceptive methods that may be used to prevent an unwanted pregnancy up to 3 days after unprotected intercourse, contraceptive failure or rape. In case of non-hormonal methods (IUD), the time window for pregnancy prevention goes up to 5 days after intercourse. The different regimens now available, hormonal and non-hormonal methods, indications, contraceptive effectiveness, side effects and safety profile, possible mechanisms of action and counseling strategies will be reviewed. The potential benefits on reproductive health of wide-spread knowledge and easy, non-restrictive access to this methodology are emphasized. An extensive list of recent references is enclosed.

Comparative assessment of two low-dose oral contraceptives, Lo-Femenal and Lo-Estrin, in Mexican women.

This trial was designed to determine the differences in effectiveness, clinical acceptability, and one-year discontinuation rates of two low-dose oral contraceptives: Lo-Estrin (norethindrone acetate 1.5 mg plus ethinyl estradiol 0.030 mg) and Lo-Femenal (norgestrel 0.30 mg plus ethinyl estradiol 0.030 mg) in 148 Mexican women. In addition, the effects of both oral contraceptive preparations on blood lipids were prospectively evaluated in a subgroup of 41 women. The results indicated that there were no differences in pregnancy rates, discontinuation or clinical acceptability between the two groups. The lipid changes observed were minimal for the Lo-Femenal subgroup and somewhat greater for the Lo-Estrin group, mainly an increase in serum triglycerides. These changes were interpreted as estrogen induced effects of norethindrone-containing oral contraceptives. Overall, the data indicate that both Lo-Femenal and Lo-Estrin are effective and safe combined oral contraceptives.

[Levonorgestrel releasing subcutaneous implants. 1st year's experience]. / Implantes subdérmicos liberadores de levonorgestrel. Primer año de experiencia.

This multicentric study was done in order to know the contraceptive efficacy and side effects of subdermal implants liberating levonorgestrel, in Mexican women. Results analysis, at one year, of 246 women, at four medical centers of Mexican Institute of Social Security (IMSS), showed that this contraceptive is highly efficacious, as there were no pregnancies in 2326 months of observation. The main side effects were: menstrual disorders in 34.8% of women; soreness in implantation site in 3.6%; headache in 13.4% and nausea, dizziness and vomiting in 11.6%. The most frequent causes for implant retirement were menstrual cycle alterations, and soreness at implantation site, with 7.3 and 3.5 respectively. The continuity rate at one year was 84.3, which was higher to what has been seen at the Institution with other temporal contraceptive methods, so the implants may be considered as one more alternative in family planning methods.

[Levonorgestrel-releasing subcutaneous implants. First year's experience]. / Implantes subdérmicos liberadores de levonorgestrel. Primer año de experiencia.

This multicentric study was done in order to know the anticonceptive efficacy and side effects of subdermic implants liberating levonorgestrel, in Mexican women. Results analysis, at one year, of 246 women, at four medical centers of Mexican Institute of Social Security (IMSS), showed that this anticonceptive is highly efficacious, as there were no pregnancies in 2326 months of observation. The main side effects were: menstrual disorders in 34.8% of women; soreness in implantation site in 3.6%; headache in 13.4% and nausea, dizziness and vomiting in 11.6%. The most frequent causes for implant retirement were menstrual cycle alterations, and soreness at implantation site, with 7.3 and 3.5 respectively. The continuity rate at one year was 84.3, which was higher to what has been seen at the Institution with other temporal anticonceptive methods, so the implants may be considered as one more alternative in family planning methods.

Clinical assessment of treatments for prolonged bleeding in users of Norplant implants.

The effectiveness of three drugs in controlling prolonged bleeding in the first year of NORPLANT implants use was tested. The drugs were levonorgestrel (L-Ng, 0.03 mg twice a day for 20 days), ethinylestradiol (EE, 0.05 mg per day for 20 days) and ibuprofen (Ib, 800 mg three times a day for 5 days) and were given orally. A control group received a placebo (PL, one pill of lactose for 20 days). Treatment should start each time a woman experienced eight consecutive days of bleeding or spotting. The 183 volunteers were not aware of the drug administered. A daily record of bleeding and spotting and of treatment intake was maintained. One-hundred-forty women completed the study period; 60 never used the prescribed treatment. Women treated with the three test drugs had significantly fewer bleeding and spotting days during the treated month and also throughout the study year than women using the placebo. The mean number of bleeding plus spotting days per actually treated subject in the first year was 77, 94, 101 and 129 days for the EE, Ib, L-Ng and PL groups, respectively. The administration of EE might help in the management of prolonged bleeding during the first year of NORPLANT implants use.

The WHO multicentre trial of the vasopressor effects of combined oral contraceptives: 1. Comparisons with IUD. Task Force on Oral Contraceptives. WHO Special Programme of Research, Development and Research Training in Human Reproduction.

Changes in blood pressure were measured at three-monthly intervals over one year in a prospective study of 704 women using an oral contraceptive (OC) containing levonorgestrel 250 ug with ethinyl estradiol 50 ug and 703 women using an intrauterine device (IUD). The study was conducted in 11 centres in seven developing and three developed countries. Women using OC developed systolic blood pressures which were 3.6-5.0 mmHg higher than those using IUDs; their diastolic pressures became 1.9-2.7 mm higher. The OC-induced change was not affected by climate, age, a family history of hypertension, stroke or heart disease or by a history of hypertension in pregnancy. The life-table rate of hypertension (BP 140/90 or more) in the first year of OC treatment was 0.6 +/- 0.4 in the developing countries and 1.1 +/- 0.8 in the developed ones, per 100 woman-years of use. The vasopressor response to OC varied widely between centres but was not obviously related to the economic development of the country.

Hormonal contraception: new long-acting methods.

PIP: Before the year 2000 women around the world may have up to 5 new family planning methods to choose from. All will be very effective, convenient to use, and long-acting -- from 1 month to 5 years. All use a progestin, a type of female hormone that is also used in birth control pills. Norplant implants which have already been approved in 7 countries, are placed just under the skin on the inside of a woman's arm. 6 capsules release the progestin levonorgestrel at a slow, steady rate. For 5 years they prevent nearly all pregnancies. Biodegradable implants also are placed under the skin, but they eventually dissolve and disappear. Injectable microspheres and microcapsules, suspended in a solution, are given with a hypodermic needle. The tiny particles of different sizes, consisting of hormone in a polymer carrier, dissolve and release hormone at various rates, providing a nearly constant dose that prevents pregnancy for 1 to 6 months. Monthly injectables add an estrogen to a progestin to minimize menstrual changes. The vaginal ring is placed by the woman in her vagina, where it gradually releases hormone. When new long-acting methods become available, marketing and program development are essential. Production must be arranged; providers trained; logistics systems in place; and supplies available. The media, the health care professions, and other opinion leaders must be thoroughly briefed in advance. Couples must learn about the new methods. If these are properly introduced and made continuously available, there will soon be a much broader choice of contraceptives for women. Effective, reversible, long-acting hormonal contraception will be available for nearly every couple, whatever their plans and needs.^ieng

Clinical assessment of a low-dose oestrogen, low-dose progestogen combined oral contraceptive.

PIP: The efficacy, safety, and patient acceptance of an oral contraceptive containing 150 mcg d-norgestrel and 30 mcg ethinyl estradiol (150/30) were studied in 99 women who completed 754 cycles of medication between late 1971 and October 1973. 1 pregnancy occurred giving a pregnancy rate of 1.6 per 100 woman-years. This woman's previous history indicated unreliability in pill taking. The mean pretreatment length of menses was 4.9 days and during treatment, 4 days. Although intermenstrual bleeding and amenorrhea were noted in early cycles, there was a decrease in the usual incidence of headaches, nausea, vomiting, and depression. Results of the study and patients' acceptance suggest that the 150/30 combination may be used as the oral contraceptive of first choice.^ieng

Clinical assessment of a low-oestrogen combined oral contraceptive.

PIP: A 21-tablet oral contraceptive packet containing .5 mg dl-norgestrel and .03 mg estradiol was clinically tested in 1085 women of reproductive age for a total of 7323 cycles. There was 1 pregnancy which may have been due to incorrect tablet use. 98.2% of the cycles fell within a 28-day plus or minus 3-day pattern. 21% of the women had some breakthrough bleeding at some time, but it was confined to 1 cycle in 63% and not more than 2 cycles in 82%. The contraceptive is recommended for general use on the bases of how pregnancy rate, mean intermenstrual bleeding of .54 days per cycle, and the mean total bleeding of 4.87 days per cycle. The hypothesis that an effective combined oral contraceptive using norgestrel as the progestogen can employ as little as 30 mcg of estrogen is supported.^ieng