Noncomparative contraceptive efficacy of cellulose sulfate gel.
OBJECTIVE
To estimate the 6-month cumulative probability of pregnancy, short-term adverse effects, and acceptability of cellulose sulfate vaginal contraceptive gel.


METHODS
Two hundred fertile heterosexual couples were enrolled in this single-center, phase II, 6-month noncomparative study conducted at the California Family Health Council in Los Angeles, California. Couples did not desire pregnancy, were at low risk for sexually transmitted diseases, and agreed to use 3.5 mL of cellulose sulfate gel 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 6 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 cards.


RESULTS
The cumulative probabilities of pregnancy during 6 months and six cycles of typical use were 13.4% (95% confidence interval [CI] 7.5-19.4%) and 13.9% (95% CI 7.7-20.2%), respectively, and during 6 cycles of correct and consistent ("perfect") use: 3.9% (95% CI 0.0-9.2%). Slightly over one fourth 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 cellulose sulfate gel for contraception.


CONCLUSIONS
Cellulose sulfate vaginal gel yields pregnancy rates comparable to nonoxynol-9 and few adverse events among couples at low risk for sexually transmitted diseases.
Mauck
Christine K
CK
CONRAD, Eastern Virginia Medical School (EVMS), Arlington, Virginia 22209, USA. cmauck@conrad.org
Freziers
Ron G
RG
Walsh
Terri L
TL
Peacock
Karen
K
Schwartz
Jill L
JL
Callahan
Marianne M
MM
D000328:Adult; D002482:Cellulose / Q000031:analogs & derivatives* / Q000494:pharmacology; D003267:Contraception / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D011247:Pregnancy; D012747:Sexual Partners; D013089:Spermatocidal Agents / Q000494:pharmacology*; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies / Q000494:pharmacology*
D013089:Spermatocidal Agents; D014622:Vaginal Creams, Foams, and Jellies; D002482:Cellulose; C020254:cellulose sulfate