NCT01768962

Tenofovir Levels Following Local Application of Tenofovir Reduced-Glycerin 1% Gel

A Phase 1 Crossover Trial Evaluating the Pharmacokinetics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: CONRAD · Academic / Other
• Sex: Female
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To compare local and systemic pharmacokinetics of tenofovir reduced-glycerin (TFV RG) 1% gel after 2 weeks of daily rectal use and after 2 weeks of daily vaginal use

Conditions

• HIV Prevention

Interventions

Type	Name	Description
DRUG	Once Daily Application of TFV RG 1% Gel - Vaginal	Vaginal application
DRUG	Once Daily Application of TFV RG 1% gel - Rectal	Rectal application
DRUG	Once Daily Application of TFV RG 1% gel - Rectal	Rectal application
DRUG	Once Daily Application of TFV RG 1% Gel - Vaginal	Vaginal application

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-01-16
• Last updated: 2021-06-28

Locations

1 site across 1 country: United States