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NCT01421368 · ClinicalTrials.gov registry record · Phase 1
Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use
A Phase 1 study, sponsored by CONRAD.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT01421368: Completed Phase 1 study, sponsored by CONRAD.
NCT01421368 is a Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421368, a Phase 1 study, has completed, sponsored by CONRAD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
The purpose of the study is to examine the effects of two contraceptive methods and the menstrual cycle on the pharmacokinetics, pharmacodynamics of tenofovir 1% gel and the effect of the contraceptive methods on markers of mucosal safety.
Primary Outcome
* composite of pharmacokinetics for TFV in plasma, vaginal aspirate \& genital tissue * composite of pharmacokinetics for TFV-DP in PBMCs, endocervical cells \& genital tissue * rates of HIV-1 infection in an explant challenge assay (one site only) * immune cell activation \& mucosal histology in genital tissue * genitourinary AEs
Interventions
- DRUG Tenofovir 1% vaginal gel
- DRUG Depo-medroxyprogesterone acetate (DMPA)
- DRUG Oral contraceptive: LNG 150 mcg and EE 30 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
What the finished NCT01421368 record still lists
NCT01421368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 3 interventions - of which Tenofovir 1% vaginal gel is the first listed.
NCT01421368 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01421368 about?
NCT01421368 is a clinical study titled "Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use". The purpose of the study is to examine the effects of two contraceptive methods and the menstrual cycle on the pharmacokinetics, pharmacodynamics of tenofovir 1% gel and the effect of the contraceptive methods on markers of mucosal safety.
What is the current status of trial NCT01421368?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2012-03. Estimated completion is 2014-03.
What interventions are being tested in trial NCT01421368?
The interventions under investigation include: Tenofovir 1% vaginal gel (DRUG), Depo-medroxyprogesterone acetate (DMPA) (DRUG), Oral contraceptive: LNG 150 mcg and EE 30 mcg (DRUG).
Who is sponsoring clinical trial NCT01421368?
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 NCT01421368's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 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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