NCT01283555

Comparative Safety Study of Two Vaginal Applicators With Tenofovir

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: PATH · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Microbicide Applicator

Interventions

Type	Name	Description
DRUG	Tenofovir	Delivered using prefilled and user-filled applicator

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-01-26
• Last updated: 2012-07-16
• Results posted: 2012-06-22

Locations

1 site across 1 country: Dominican Republic