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Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system: Results of two multicentre, open-label, single-arm, phase 3 trials

The Lancet Global Health Jul 17, 2019

Archer DF, et al. - Via a two identically designed, multicentre, open-label, single-arm, phase 3 trials of 2,278 healthy, sexually active, non-pregnant, non-sterilised women aged 18–40 years between Dec 19, 2006, and Oct 9, 2009, at the 15 US sites, and between Nov 1, 2006, and July 2, 2009, at the 12 US and international sites, the researchers assessed the effectiveness of this contraceptive vaginal system and return to menses or pregnancy following use. A 21-days-in, 7-days-out segesterone acetate and ethinylestradiol contraceptive vaginal system schedule for up to 13 cycles was followed by the individuals. A total of 2,265 women and 1,303 women completed up to 13 cycles were involved in the overall efficiency analysis. For a contraceptive under a woman's control, the Pearl Index for the primary efficacy group was 2·98 per 100 woman-years and was well within the range characteristic of efficiency. The contraceptive vaginal system, as per the Kaplan-Meier analysis, was 97·5% effective, which contributed to further indication of effectiveness. Pregnancy occurrence was alike over all the cycles. All 290 follow-up women detailed that they returned to menses or were impregnated within 6 months. Hence, for 13 consecutive cycles of use, the segesterone acetate and ethinylestradiol contraceptive vaginal system was concluded as an efficient contraceptive. Moreover, this new product added to the contraceptive method mix and the 1-year duration of use which meant that women do not require to pay a visit to the clinic or pharmacy for refills every few months.
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