Gynecologic infections and colposcopy findings from a phase 3 efficacy and safety study of a contraceptive vaginal gel compared with nonoxynol-9

Abstract

Objectives: We aimed to determine safety findings from a Phase 3 study of a contraceptive vaginal gel (L-lactic acid, citric acid and potassium bitartrate). Methods: An open-label, randomized, noninferiority study of vaginal gel versus nonoxynol-9 4% evaluated 2935 women for urinary tract infections (UTIs), bacterial vaginosis (BV) and monilia over seven cycles. A subset of 138 women was examined for lesions by colposcopy. Results: Over the seven-cycle use of either vaginal gel or nonoxynol-9, less than 1% of users had a documented UTI. The prevalence of BV at baseline and at cycle seven was 6% in both product groups, and approximately two thirds of the cases were asymptomatic. At baseline, the prevalence of monilia was 4.4% and 5.2% in the vaginal gel and nonoxynol-9 product groups, respectively, and at cycle seven, the prevalence was 7.3% and 8.3% in the vaginal gel and nonoxynol-9 product groups, respectively. Some 76.1% and 73.8% of women with monilia were asymptomatic in the vaginal gel and nonoxynol-9 product groups at cycle seven, respectively. Colposcopic examinations revealed that the majority of women (69.4% and 66.7% of vaginal gel and nonoxynol-9 users, respectively) had no lesions. Across the vaginal gel and nonoxynol-9 groups, 18% and 8% of women had one to two lesions and three to four lesions, respectively. Five to six lesions were reported in 2.8% and 7.6% of vaginal gel and nonoxynol-9 product groups, respectively. One woman using vaginal gel and none using nonoxynol-9 had seven to eight lesions. Conclusions: Gynecologic infections and colposcopy findings related to the use of vaginal gel or nonoxynol-9 were minimal after seven cycles.