دورية
A comparative evaluation of the safety and contraceptive effectiveness of 65 mg and 100 mg of 90-day norethindrone (NET) injectable microspheres: a multicenter study**Partial support for this study was provided by the Program for Applied Research in Fertility Regulation (PARFR) and by Family Health International (FHI) with funds from the U.S. Agency for International Development (USAID), although the views expressed in this article do not necessarily reflect those of USAID.††The investigators and centers participating in this study were David Archer, M.D., University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (currently Director of Clinical Research, Contraceptive Research and Development Program, Norfolk, Virginia); Guiseppe Benagiano, M.D., Associazione per Studio della Riproduzione Umana Rome, Italy; Horacio Croxatto, M.D., Instituto Chileno de Medicini Reproductiva, Santiago, Chile; Jerome Hoffman, M.D., Mount Sinai Medical Center, Miami Beach, Florida; Andrew Kauni
| العنوان: | A comparative evaluation of the safety and contraceptive effectiveness of 65 mg and 100 mg of 90-day norethindrone (NET) injectable microspheres: a multicenter study**Partial support for this study was provided by the Program for Applied Research in Fertility Regulation (PARFR) and by Family Health International (FHI) with funds from the U.S. Agency for International Development (USAID), although the views expressed in this article do not necessarily reflect those of USAID.††The investigators and centers participating in this study were David Archer, M.D., University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (currently Director of Clinical Research, Contraceptive Research and Development Program, Norfolk, Virginia); Guiseppe Benagiano, M.D., Associazione per Studio della Riproduzione Umana Rome, Italy; Horacio Croxatto, M.D., Instituto Chileno de Medicini Reproductiva, Santiago, Chile; Jerome Hoffman, M.D., Mount Sinai Medical Center, Miami Beach, Florida; Andrew Kauni |
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| المؤلفون: | Grubb, Gary S., Welch, Julia D., Cole, Lynda, Goldsmith, Alfredo, Rivera, Roberto |
| المصدر: | Fertility and Sterility; May 1989, Vol. 51 Issue: 5 p803-810, 8p |
| مستخلص: | The first of a second generation of slow-release injectable contraceptives is the noreth-indrone (NET) microspheres with a 90-day duration of action. It was evaluated at 65-mg and 100-mg doses for safety and contraceptive effectiveness in two randomized, singleblind trials among 131 women: 94 women for 12 months and 37 women for 6 months. The 6-month trial included additional evaluations of ovarian function and serum NET values. In the 6-month trial, no indication of ovulation was detected in the 100-mg dose group, while 3 of the 19 women in the 65-mg group showed signs of ovulation (progesterone > 3 ng/ml). No pregnancies were reported in the 100-mg group and one pregnancy in the 65mg group resulted in a life-table pregnancy rate for that dose of 2.6 per 100 woman-years (95% confidence interval, 0 to 7.5). Days of vaginal bleeding were analyzed for 30 days before treatment and in 90-day reference periods after treatment. The mean number of vaginal bleeding and spotting days increased initially after the first injection in both dose groups, but decreased to below baseline in both dose groups after 6 months. The two doses appear comparable in clinical safety, side effects, vaginal bleeding patterns, and laboratory measures. With the preliminary estimate of efficacy, the 65-mg dose would be the minimally effective dose for the NET 90-day injectable contraceptive. |
| قاعدة البيانات: | Supplemental Index |
| تدمد: | 00150282 15565653 |
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| DOI: | 10.1016/S0015-0282(16)60670-2 |