NCT02245945

Safety and Acceptability of Tenofovir 1% Gel in Adolescent Females

Phase I Safety and Acceptability of Tenofovir 1% Gel in Adolescent Females

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: CONRAD · Academic / Other
• Sex: Female
• Age: 15 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to assess the safety and acceptability of Tenofovir (TFV) 1% gel in adolescent females over 12 weeks of a minimum of twice weekly dosing following the BAT24 regimen.

Conditions

• HIV Prevention

Interventions

Type	Name	Description
DRUG	TFV 1% vaginal gel	Tenofovir 1% gel is supplied as a clear, transparent, viscous gel packaged in pre-filled single use applicators. Each applicator contains 4.0 mL of tenofovir gel (equal to 4.4 gm) at a concentration of 1% (weight for weight) formulated in purified water with edetate disodium, citric acid, glycerin, methylparaben, propylparaben and hydroxyethylcellulose, and is pH adjusted to 4-5.
DRUG	HEC Placebo Gel	Placebo gel contains hydroxyethylcellulose (HEC) as the gel thickener, purified water, sodium chloride, sorbic acid and sodium hydroxide. The gel is isotonic and formulated at a pH of 4.4. Each pre-filled applicator will contain approximately 4 mL of placebo gel for delivery.

Timeline

• Primary completion: 2015-04-01
• First posted: 2014-09-22
• Last updated: 2015-05-01

Locations

2 sites across 1 country: United States