A pilot safety and tolerability study of a nonhormonal vaginal contraceptive ring

Giuseppe Del Priore, Jeanetta Malanowska-Stega, Shalaby W. Shalaby, Susan Richman

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: To conduct a pilot safety and tolerability study of the Ovaprene ring (Poly-Med Inc., Clemson University, Clemson, South Carolina) as a barrier contraceptive. STUDY DESIGN: Open-label, single-arm, observational study in a convenient sample of volunteers. Women meeting inclusion criteria and using another contraceptive method were instructed in proper insertion of the ring at the completion of their menses, with removal at their subsequent menses or 29 days. Baseline Pap smears, vaginal cultures and colposcopy were performed, with follow-up postcoital testing and acceptability questionnaires. RESULTS: Twenty women enrolled: all completed one cycle of use. Rings were inserted properly and retained in place (range, 5-29 days). Patient questionnaires revealed no pain or bleeding, and no colposcopic abnormalities were seen. Semiquantitative cultures yielded no significant changes in vaginal flora. Postcoital testing revealed nonviable sperm (motile/total, mean count/10 high power fields) 2/> 20 in the vaginal pool and 0/0 in cervical mucus. There were no serious adverse effects. CONCLUSION: The Ovaprene device is well tolerated and acceptable to sexually active women and their partners.

Original languageEnglish (US)
Pages (from-to)685-690
Number of pages6
JournalJournal of Reproductive Medicine for the Obstetrician and Gynecologist
Volume54
Issue number11-12
StatePublished - Nov 1 2009

Keywords

  • Barrier contraception
  • Ovaprene
  • Postcoital testing

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Reproductive Medicine

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