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


METHODS
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.


CONCLUSIONS
The Ovaprene device is well tolerated and acceptable to sexually active women and their partners.
Del Priore
Giuseppe
G
Research Department, NY Downtown, New York, New York, USA.
Malanowska-Stega
Jeanetta
J
Shalaby
Shalaby W
SW
Richman
Susan
S
D000282:Administration, Intravaginal; D000328:Adult; D003274:Contraceptive Devices, Female / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D018579:Patient Selection; D010865:Pilot Projects; D011795:Surveys and Questionnaires