Overview

Ovarian Function With ENG Implant and UPA Use

Status:
Recruiting
Trial end date:
2023-03-03
Target enrollment:
Participant gender:
Summary
Same day initiation of the etonogestrel (ENG) implant and oral ulipristal acetate (UPA) would overcome contraceptive access barriers to women with recent unprotected intercourse to ongoing contraception. Current clinical guidelines recommend delaying implant initiation for at least 1 week following UPA, as well as waiting 7 days before relying on the implant for contraception after initiation alone. This pilot will assess the effects of the implant alone and the implant inserted with same-day as UPA usage on ovarian activity. A total of 40 women desiring the implant, who are not at risk for pregnancy during the study timeline, will be recruited. Participants will be randomized to implant alone or same-day implant + oral UPA. Participants will have daily ultrasounds and blood draws to assess timing of ovulation for 1 week and then an exit visit at 14 days after randomization. The primary outcome is the incidence of ovulation in the 2 randomized treatment groups. Participants may continue the implant after the study per FDA guidelines and rely on it for contraception after the study is completed.
Phase:
Early Phase 1
Details
Lead Sponsor:
University of Utah
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Contraceptive Agents
Etonogestrel
Ulipristal acetate