Female Contraception Clinical Trial
Official title:
A Multicenter, Open-label Randomized Study on the Efficacy, Cycle Control and Safety of a Contraceptive Vaginal Ring Delivering a Daily Dose of Nestorone® and Estradiol (NES-E2 CVR).
This will be a multi-site, open-label, randomized clinical trial. The investigators will randomize 300 eligible participants in a 1:1 ratio to two different treatment regimens that are to be followed when using a contraceptive vaginal ring delivering a daily dose of Nestorone® and estradiol (NES-E2 CVR).
The total duration of the study for each participant is expected to be approximately
13.5-15.5 months: including screening and enrollment (up to 8 weeks), 12 months of
participation, and a post-removal follow up period removal of at least 17 days. After
enrollment, subject visits occur at day 31, 92, 183, 274, and 364 with telephone calls at day
60, 120, 150, 210, 240, 300, and 330. Subjects will use a home pregnancy test 17 days
post-removal of the ring and will call the site report the result and for safety follow-up.
Another phone call will be required after that if the subject chooses not to being a hormonal
contraceptive; this call will occur at the time of the subject's first spontaneous menses.
Subject recruitment is expected to begin Q1 (in the first quarter of) 2018 and is planned to
continue through Q1 2019. However, if the enrollment rate declines, the enrollment period may
be extended beyond this date. If this enrollment timeline is met, all subjects should finish
active treatment by approximately the end of Q1 2020. The end of the study will occur when
the last subject to be enrolled has completed her post-removal telephone call(s).
Preliminary results of the study are expected to be available Q3 of 2020 based on the current
study plan.
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