Christine Mauck, Andrea Thurman, Jeffrey T Jensen, Courtney A Schreiber, Jeff Baker, Melody Y Hou, Steven Chavoustie, Clint Dart, Hongsheng Wu, Jacques Ravel, Pawel Gajer, Betsy C Herold, Terry Jacot, Nadene Zack, Jessica Hatheway, Dave Friend
OBJECTIVE: Evaluate safety of Ovaprene, an investigational non-hormonal vaginal contraceptive designed for monthly use. STUDY DESIGN: Open-label, multicenter study enrolling heterosexually-active women with previous permanent contraception who underwent assessments during five menstrual cycles: baseline postcoital test cycle, diaphragm postcoital test cycle, Ovaprene safety cycle, and two Ovaprene postcoital test cycles. Safety outcomes included treatment emergent adverse events (TEAEs), systemic laboratory findings, pelvic examinations, colposcopies, Nugent scores, determination of community state types of vaginal microbiota, and anti-Escherichia coli activity and inflammatory markers in cervicovaginal fluids...
March 27, 2024: Contraception