Safety, tolerance and acceptability of the Invisible Condom® and its vaginal applicator in healthy women and their male sexual partners☆

Abstract 

Objectives

The study was conducted to evaluate the safety and acceptability of the Invisible Condom® when applied once or twice daily for 14 days in healthy women and their male sexual partners.

Study Design

Forty-one women and 23 men divided into three cohorts were enrolled. Cohort 1: 14 sexually abstinent women applying gel twice daily for 14 days; Cohort 2: 14 sexually active women with tubal ligation applying gel once daily for 14 days and their 14 sexual partners who did not use gel; Cohort 3: 13 women on oral contraceptive applying gel once daily for 14 days and 9 of their sexual partners.

Results

No serious adverse events (AEs) were reported. Colposcopy showed no genital ulceration nor epithelial lesions. No major changes in vaginal flora or vaginal pH were detected. None of the women had to stop product application because of AEs. The majority of AEs were mild. Common AEs were itching, dryness, burning sensation, erythema and discharge. Satisfaction questionnaire showed that the gel and applicator were acceptable.

Conclusion

The Invisible Condom® and applicator were safe, well tolerated and acceptable when applied intravaginally for 14 days. Thus, expanded safety and effectiveness evaluation is warranted.

Keywords: Phase I trial, Invisible Condom®, Women, Vaginal microbicides, HIV prevention