Safety testing of Ovaprene: An investigational nonhormonal monthly vaginal contraceptive.

Autor: Mauck C; Daré Bioscience, Inc., San Diego, CA, United States. Electronic address: cmauck@darebioscience.com., Thurman A; Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, United States., Jensen JT; Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, OR, United States., Schreiber CA; Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, United States., Baker J; Clinical Research Prime, Idaho Falls, ID, United States., Hou MY; Department of Obstetrics and Gynecology, University of California Davis, Sacramento, CA, United States., Chavoustie S; Segal Institute for Clinical Research Inc., Miami, FL, United States., Dart C; Premier Research, Morrisville, NC, United States., Wu H; Premier Research, Morrisville, NC, United States., Ravel J; Department of Microbiology and Immunology, University of Maryland School of Medicine, Institute for Genome Sciences, Baltimore, MD, United States., Gajer P; Department of Microbiology and Immunology, University of Maryland School of Medicine, Institute for Genome Sciences, Baltimore, MD, United States., Herold BC; Department of Microbiology and Immunology, Albert Einstein College of Medicine, Bronx, NY, United States., Jacot T; Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA, United States., Zack N; Daré Bioscience, Inc., San Diego, CA, United States., Hatheway J; Daré Bioscience, Inc., San Diego, CA, United States., Friend D; Daré Bioscience, Inc., San Diego, CA, United States.
Jazyk: angličtina
Zdroj: Contraception [Contraception] 2024 Jul; Vol. 135, pp. 110440. Date of Electronic Publication: 2024 Mar 27.
DOI: 10.1016/j.contraception.2024.110440
Abstrakt: Objectives: Evaluate the safety of Ovaprene, an investigational nonhormonal 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, 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.
Results: We enrolled 38 participants. Of these, 33 used Ovaprene and completed 77 Ovaprene cycles. The most common product-related urogenital treatment-emergent adverse events were bacterial vaginosis and vaginal odor. The frequency of transitioning from Lactobacillus-dominated community state type to community state type IV (not Lactobacillus-dominated) was similar before Ovaprene use and afterwards. Mean Nugent scores were <4 at each visit without a discernible upward trend. Inflammatory markers showed wide variation but no upward trend, and E. coli inhibitory activity of cervical secretions did not change. We found no Staphylococcus aureus, the causative agent in toxic shock syndrome, on used Ovaprenes or in vaginal samples. No clinically important changes in systemic laboratory findings, pelvic examinations, or colposcopies occurred during Ovaprene use.
Conclusions: Ovaprene use did not result in cervicovaginal irritation or adverse effects on resident vaginal microbiota and did not impact transitions from a Lactobacillus-dominated community state type to community state type IV.
Implications: The finding that the use of Ovaprene, an investigational monthly user-controlled nonhormonal vaginal contraceptive, does not appear to result in adverse changes in vaginal health during short-term use supports further evaluation of the contraceptive potential of the device.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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