# A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04

> **NCT01989663** · PHASE1 · COMPLETED · sponsor: **CONRAD** · enrollment: 78 (actual)

## Conditions studied

- HIV

## Interventions

- **DRUG:** 1% vaginally applied tenofovir gel
- **DRUG:** Tenofovir film- 10mg
- **DRUG:** Tenofovir Film-40 mg
- **OTHER:** HEC Placebo Gel
- **OTHER:** Placebo Vaginal Film

## Key facts

- **NCT ID:** NCT01989663
- **Lead sponsor:** CONRAD
- **Sponsor class:** OTHER
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-11
- **Primary completion:** 2015-01
- **Final completion:** 2015-01
- **Target enrollment:** 78 (ACTUAL)
- **Last updated:** 2016-07-27

## Collaborators

- [object Object]
- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01989663

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01989663, "A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT01989663. Licensed CC0.

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