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NCT03279120 · ClinicalTrials.gov registry record · Phase 1
Safety, PK, and PD Study of IVRs Releasing TFV and LNG
A Phase 1 study, sponsored by CONRAD.
- Completed
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
NCT03279120: Completed Phase 1 study, sponsored by CONRAD.
NCT03279120 is a Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03279120, a Phase 1 study, has completed, sponsored by CONRAD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
Study Summary
This multi-center Phase I study is designed to characterize the safety, PK, and PD of TFV/LNG IVR to assess systemic and genital tract bioavailability in healthy women. The IVRs to be used in the study are TFV/LNG IVR (8-10mg per day/20μg per day) or placebo IVR. Samples will be obtained before, during and after 90 days of continuous or interrupted IVR use.
Primary Outcome
Treatment-emergent adverse events (TEAEs)
Interventions
- DRUG Placebo
- DRUG TFV/LNG IVR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2017-09-28 |
| Est. Completion | 2018-12-26 |
| Phase | Phase 1 |
What the finished NCT03279120 record still lists
NCT03279120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03279120 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03279120 about?
NCT03279120 is a clinical study titled "Safety, PK, and PD Study of IVRs Releasing TFV and LNG". This multi-center Phase I study is designed to characterize the safety, PK, and PD of TFV/LNG IVR to assess systemic and genital tract bioavailability in healthy women. The IVRs to be used in the study are TFV/LNG IVR (8-10mg per day/20μg per day) or placebo IVR. Samples will be obtained before, dur...
What is the current status of trial NCT03279120?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2017-09-28. Estimated completion is 2018-12-26.
What interventions are being tested in trial NCT03279120?
The interventions under investigation include: Placebo (DRUG), TFV/LNG IVR (DRUG).
Who is sponsoring clinical trial NCT03279120?
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 NCT03279120's enrollment target sits among peer trials
66 786th of 2000 higher than 1,203 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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