Comparative Safety Study of Two Vaginal Applicators With Tenofovir

Microbicide Applicator Clinical Trial

Official title: Comparative Safety Study of Pre-Filled Plastic and User-Filled Paper Vaginal Applicators With Candidate Microbicide, Tenofovir

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Microbicide Applicator

• NCT number: NCT01283555
• Study type: Interventional
• Source: PATH
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Completion date: June 2011