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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 is a Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 66 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03279120
The ClinicalTrials.gov registry entry for NCT03279120 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 66 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 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03279120 reports 0 study locations.
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.
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