Effects of a novel estrogen-free, progesterone receptor modulator contraceptive vaginal ring on inhibition of ovulation, bleeding patterns and endometrium in normal women

Vivian Brache, Regine Sitruk-Ware, Alistair Williams, Diana Blithe, Horacio Croxatto, Narender Kumar, Sushma Kumar, Yun Yen Tsong, Irving Sivin, Anita Nath, Heather Sussman, Leila Cochon, Maria Jose Miranda, Verónica Reyes, Anibal Faundes, Daniel Mishell

Research output: Contribution to journalArticlepeer-review

38 Citations (Scopus)

Abstract

Background: Progesterone receptor modulators (PRMs) delivered by contraceptive vaginal rings provide an opportunity for development of an estrogen-free contraceptive that does not require daily oral intake of steroids. The objective of this proof-of-concept study was to determine whether continuous delivery of 600-800 mcg of ulipristal acetate (UPA) from a contraceptive vaginal ring could achieve 80% to 90% inhibition of ovulation. Study Design: This was a prospective, controlled, open-labeled, multicenter international trial to examine the effectiveness and safety of this prototype vaginal ring. Thirty-nine healthy women, 21-40 years old and not at risk of pregnancy, were enrolled at three clinic sites. Volunteers participated in a control cycle, a 12-week treatment period and a post-treatment cycle. Pharmacodynamic effects on follicular function and inhibition of ovulation, effects on endometrium, bleeding patterns and serum UPA levels were evaluated. Results: Mean UPA levels during treatment were nearly constant, approximately 5.1 ng/mL throughout the study. Ovulation was documented in 32% of 111 "4-week treatment cycles." A correlation was observed between serum UPA and degree of inhibition of ovarian activity. There was no evidence of hyperplasia of endometrium, but PRM-associated endometrial changes were frequently observed (41%). Conclusion: In this study, the minimum effective contraceptive dose was not established. Further studies are required testing higher doses of UPA to attain ovulation suppression in a higher percentage of subjects.

Original languageEnglish
Pages (from-to)480-488
Number of pages9
JournalContraception
Volume85
Issue number5
DOIs
Publication statusPublished - May 2012

Keywords

  • Contraceptive vaginal ring
  • Follicular development
  • Ovulation inhibition
  • PRM-associated endometrial changes
  • Progesterone receptor modulators
  • Ulipristal acetate

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynaecology

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