Results

Non-Comparative Contraceptive Effectiveness Trial of Cellulose Sulfate (CS) Gel

CK Mauck, R Frezieres, T Walsh, K Peacock, J Schwartz, MM Callahan. Obstetrics & Gynecology, (2006: April) 107:14S

Objectives: To assess the 6-month cumulative probability of pregnancy, safety, and acceptability of cellulose sulfate (CS) vaginal contraceptive gel.

Methods: 200 fertile heterosexual couples were enrolled at this single-center, Phase II, 6-month non-comparative study conducted at the California Family Health Council in Los Angeles, CA. Couples did not desire a pregnancy, were at low risk for sexually transmitted infections (STIs), and agreed to use 3.5 ml of CS intravaginally before each coital act as their primary means of contraception. Scheduled follow-up visits took place after one menstrual cycle and at study completion, which occurred after six months and six menstrual cycles had elapsed. In addition, participants were instructed to call the site at the onset of each menses to review their diary card.

Results: The cumulative probabilities of pregnancy during 6 months and 6 cycles of typical use were 13.4% (7.5-19.4) and 13.9% (7.7-20.2), respectively, and during 6 cycles of consistent use: 3.0% (0.0-7.2). Slightly over one quarter of the women and one man reported experiencing gel-related adverse events, two thirds of which were mild and only possibly related to the gel. Three quarters of women and men reported that they would buy CS gel for contraception.

Conclusion: CS appears to be safe and effective when used as a vaginal contraceptive gel among couples at low risk for STIs. The pregnancy probabilities compare well with nonoxynol-9 (N-9).

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