Comparative Safety Study of Two Vaginal Applicators With Tenofovir

Summary

The primary objective of this study is to compare the effect of two vaginal applicators, delivering the candidate microbicide Tenofovir, on symptoms and signs of irritation of the external genitalia, cervix and vagina as seen on colposcopy after seven days of twice daily use. The secondary objectives are to: 1. Evaluate and compare the dosing accuracy and precision of the user-filled applicator and pre-filled applicator with the candidate microbicide, Tenofovir. 2. Compare the acceptability of the user-filled applicator with the pre-filled applicator.

Timeline

Start

2011-01

Primary completion

2011-06

Completion

2011-06

Outcome

Missed primary endpoint

registry Baseline Colposcopic Findings vs Colposcopic Findings After 7 Days of Product Use; p = 0.4870; Fisher Exact NCT01283555 ↗

Drugs

Indications

No indication recorded.