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NCT01989663 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04
A Phase 1 study, sponsored by CONRAD.
- Completed
- Registry status
- Phase 1
- Development phase
- 78
- Enrollment target
NCT01989663: Completed Phase 1 study, sponsored by CONRAD.
NCT01989663 is a Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 78 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01989663, a Phase 1 study, has completed, sponsored by CONRAD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 78 participants
- Enrollment target
Study Summary
This is a Phase I, five arm, single site, randomized, double blind placebo-controlled trial assessing the safety of tenofovir vaginal gel and film formulations. HIV negative women will be randomized to gel or film, tenofovir or placebo. This study will provide additional information in the evaluation of vaginal films containing microbial agents in humans. In addition to safety, the efficacy of these formulations against HIV in an ex vivo biopsy challenge model will be compared. This study is the first study assessing the safety of tenofovir film in humans. Tenofovir film is formulated in a cellulose based vaginal film containing hydroxypropyl methyl cellulose (HPMC) E5 (5 cp), hydroxyethyl cellulose (HEC), Sodium Carboxymethylcellulose (NaCMC), and glycerin. The excipients of the film have documented safety in other clinical settings. While the tenofovir film has not been studied extensively in preclinical studies, there are favorable safety data from the macaque study and a substantial body of research with tenofovir gel. It is appropriate to advance the tenofovir film products into a clinical trial for the following reasons: * No safety concerns were note in the tenofovir film macaque trial. * The toxicity of tenofovir administered vaginally has been studied extensively. No clinically significant toxicity associated with this route of administration has been observed to date. * All of the active ingredients of the tenofovir film have been tested in pre-clinical toxicity studies; therefore, the influence of these ingredients on the toxicity profile of tenofovir has been adequately evaluated and has been shown to result in no local or systemic effects. * The individual components of the tenofovir film have been adequately evaluated and have been shown to be safe.
Primary Outcome
To assess the safety of gel and two film formulations of tenofovir
Interventions
- OTHER Placebo Vaginal Film
- DRUG 1% vaginally applied tenofovir gel
- DRUG Tenofovir film- 10mg
- DRUG Tenofovir Film-40 mg
- OTHER HEC Placebo Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT01989663 record still lists
NCT01989663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo Vaginal Film is the first listed.
NCT01989663 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01989663 about?
NCT01989663 is a clinical study titled "A Phase I Trial to Assess the Safety of Tenofovir Gel and Film Formulations: FAME 04". This is a Phase I, five arm, single site, randomized, double blind placebo-controlled trial assessing the safety of tenofovir vaginal gel and film formulations. HIV negative women will be randomized to gel or film, tenofovir or placebo. This study will provide additional information in the evaluatio...
What is the current status of trial NCT01989663?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2013-11. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01989663?
The interventions under investigation include: Placebo Vaginal Film (OTHER), 1% vaginally applied tenofovir gel (DRUG), Tenofovir film- 10mg (DRUG), Tenofovir Film-40 mg (DRUG), HEC Placebo Gel (OTHER).
Who is sponsoring clinical trial NCT01989663?
This trial is sponsored by CONRAD, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01989663's enrollment target sits among peer trials
78 697th of 2000 higher than 1,298 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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