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NCT00408538 · ClinicalTrials.gov registry record · Phase 1

Safety and Acceptability Study of the UC-781 Microbicide Gel Applied Rectally

A Phase 1 study, sponsored by University of California, Los Angeles.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT00408538 is a Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 36 participants.

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The verdict

NCT00408538, a Phase 1 study, has completed, sponsored by University of California, Los Angeles.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study Summary

This study is the first to try this product in the rectum of humans. This study is only to find out if the gel is safe for use in the rectum, not to see if the gel works. Information gathered from this study will help investigators decide whether this gel is safe enough to move onto the next phase of studies. Information gathered from this study will also help investigators determine what participants did and did not like about the product and what types of products people might want to use in the future. Currently condoms and abstinence are the only methods proven to prevent the spread of HIV sexually.

Interventions

  • DRUG placebo
  • DRUG UC-781 microbicide gel (0.1% and 0.25%)

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2006-12
Est. Completion 2008-04
Phase Phase 1

What the Registry Record Tells You About NCT00408538

The ClinicalTrials.gov registry entry for NCT00408538 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00408538 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00408538 about?

NCT00408538 is a clinical study titled "Safety and Acceptability Study of the UC-781 Microbicide Gel Applied Rectally". This study is the first to try this product in the rectum of humans. This study is only to find out if the gel is safe for use in the rectum, not to see if the gel works. Information gathered from this study will help investigators decide whether this gel is safe enough to move onto the next phase o...

What is the current status of trial NCT00408538?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2006-12. Estimated completion is 2008-04.

What interventions are being tested in trial NCT00408538?

The interventions under investigation include: placebo (DRUG), UC-781 microbicide gel (0.1% and 0.25%) (DRUG).

Who is sponsoring clinical trial NCT00408538?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.