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NCT01232803 · ClinicalTrials.gov registry record · Phase 1
Rectal Safety and Acceptability Study of Tenofovir 1% Gel
A Phase 1 study of Rectal Microbicides, sponsored by CONRAD.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 3
- Study locations
NCT01232803 is a Phase 1 study of Rectal Microbicides that has completed, run by CONRAD. The registered enrollment target is 65 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT01232803, a Phase 1 study of Rectal Microbicides, has completed, sponsored by CONRAD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 3
- Study locations
Study Summary
MTN-007 is a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study of vaginally formulated tenofovir 1% gel (a reduced-glycerin formulation), when applied rectally. The primary objective of this study is to assess the safety of vaginally formulated tenofovir 1% gel when applied rectally. After completing screening and baseline evaluation, eligible participants will be randomized to receive tenofovir 1% gel, 2% nonoxynol-9 gel (N-9) or placebo gel. The study will also include a no treatment arm. There will be 15 participants in each arm. Participants will return to the clinic, where they will self-administer a single dose of the study gel under observation. Within approximately 30 minutes, lavage, stool, and rectal biopsy specimens will be obtained. After a one-week recovery period, participants will return to the clinic for assessment. If no significant adverse events (AEs) are reported they will begin to self-administer once-daily outpatient doses of the study gel for 7 days. Participants will return to clinic for evaluation and specimen collection after completion of 7 days of daily dosing.
Conditions Studied
Interventions
- DRUG Tenofovir 1% gel
- DRUG 2% N-9 gel
- DRUG HEC Placebo gel
Study Locations (3)
Alabama
- University of Alabama at Birmingham - Birmingham
Massachusetts
- The Fenway Institute - Boston
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2010-10 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01232803
The ClinicalTrials.gov registry entry for NCT01232803 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CONRAD, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rectal Microbicides appearing as the primary indexed condition, and to 3 interventions - of which Tenofovir 1% gel is the first listed.
NCT01232803 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Alabama, Massachusetts, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01232803 about?
NCT01232803 is a clinical study titled "Rectal Safety and Acceptability Study of Tenofovir 1% Gel". MTN-007 is a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study of vaginally formulated tenofovir 1% gel (a reduced-glycerin formulation), when applied rectally. The primary objective of this study is to assess the safety of vaginally formulated tenofovir 1% gel when app...
What is the current status of trial NCT01232803?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2010-10. Estimated completion is 2011-07.
What conditions does trial NCT01232803 study?
This clinical trial studies the following conditions: Rectal Microbicides.
What interventions are being tested in trial NCT01232803?
The interventions under investigation include: Tenofovir 1% gel (DRUG), 2% N-9 gel (DRUG), HEC Placebo gel (DRUG).
Who is sponsoring clinical trial NCT01232803?
This trial is sponsored by CONRAD, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01232803 being conducted?
This trial has 3 study locations across Alabama, Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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