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NCT00561496 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel
A Phase 1 study, sponsored by CONRAD.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT00561496: Completed Phase 1 study, sponsored by CONRAD.
NCT00561496 is a Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00561496, a Phase 1 study, has completed, sponsored by CONRAD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
This is a multi-center, pharmacokinetic study involving a single-dose phase, a wash out phase and a two-week once or twice-daily dosing phase for each of 49 volunteers. In the single-dose phase, each volunteer will apply the single dose in the clinic. Participants will be randomized to have cervicovaginal samples and biopsies collected at one of seven time-points \[0.5, 1, 2, 4, 6, 8, and 24 hour(s)\] after the single-dose. Blood samples will be drawn at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) after the single-dose. In the two-week phase, the study supplies will be distributed and the participants will be randomized to apply each dose either once or twice-daily for two weeks. At the one week follow-up visit a blood sample will be drawn prior to the morning dose to obtain a trough value and cervicovaginal samples will be collected four hours after the morning dose. At the two week follow-up visit blood samples will be drawn prior to the morning dose to obtain a trough value and then at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) from the final morning dose. Participants will be randomized to have cervicovaginal samples and biopsies collected at either 4, 8 or 24 hours after the final morning dose. Up to 10 participants who have completed the first two phases of the study, will be asked to participate in a third phase to have cervicovaginal samples, biopsies and blood samples collected 12 hours after a single-dose.
Interventions
- DRUG Tenofovir gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-04 |
| Phase | Phase 1 |
What the finished NCT00561496 record still lists
NCT00561496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 1 intervention - of which Tenofovir gel is the first listed.
NCT00561496 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00561496 about?
NCT00561496 is a clinical study titled "Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel". This is a multi-center, pharmacokinetic study involving a single-dose phase, a wash out phase and a two-week once or twice-daily dosing phase for each of 49 volunteers. In the single-dose phase, each volunteer will apply the single dose in the clinic. Participants will be randomized to have cervico...
What is the current status of trial NCT00561496?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2007-03. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00561496?
The interventions under investigation include: Tenofovir gel (DRUG).
Who is sponsoring clinical trial NCT00561496?
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 NCT00561496's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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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