Background: IPM is evaluating the safety and efficacy of a dapivirine vaginal ring for the prevention of HIV-1 acquisition through male to female transmission. Once the safety and efficacy of the dapivirine vaginal ring have been proven, it should be fully compatible with concurrent use of male and female condoms. The functionality of female condoms (FCs) with the vaginal ring was evaluated.
Methods: The total clinical failure rate of FCs in the presence and absence of a placebo vaginal ring was assessed in an open-label, randomized, two-period, crossover non-inferiority trial. Eighty-one healthy, monogamous, heterosexual couples, aged 18-55 years, were enrolled. Each couple used 4 study FCs when the female was wearing the vaginal ring and 4 study FCs when the female was not wearing the ring. The total clinical failure rate was defined as the number of FCs with breakage, complete slippage, misdirection or invagination during intercourse, divided by the number of FCs used. The safety, tolerability and acceptability of FCs in the presence of the vaginal ring and the frequency of ring expulsion or removal were assessed.
Results: 297 FCs were used with the vaginal ring and 299 FCs without the ring. The total clinical failure rate was 14.1% with the vaginal ring and 15.7% without the ring. The difference “with ring–without ring” was -2.1% (95% CI: -7.8%; 3.6%). The upper bound of the CI was less than the pre-defined non-inferiority margin of 8%. No clinical breakage during intercourse was reported with or without the ring. Five adverse events (AEs) were reported: genital burning sensation (1 male), pelvic discomfort, bacterial vaginitis and two events of vulvovaginal discomfort (4 females). Two product-related AEs were reported (Grade 1): bacterial vaginitis (with ring) and vulvovaginal discomfort (without ring). No serious AEs were reported; no AE led to trial discontinuation. Use of the vaginal ring resulted in more couples feeling the vaginal ring or FC inner ring, more movement of these rings during intercourse and more interference of the rings with intercourse, which increased the odds of them being bothered by the vaginal ring, affecting sexual satisfaction.
Conclusions: Female condom use was safe with vaginal ring use. The presence of the vaginal ring did not negatively affect the total clinical failure rate of FCs. No ring expulsions or removals during intercourse were reported.