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NCT02235662 · ClinicalTrials.gov registry record · Phase 1
Phase I One-month Safety, PK, PD, and Acceptability Study of IVR Releasing TFV and LNG or TFV Alone
A Phase 1 study, sponsored by CONRAD.
- Completed
- Registry status
- Phase 1
- Development phase
- 86
- Enrollment target
NCT02235662 is a Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 86 participants.
The verdict
NCT02235662, a Phase 1 study, has completed, sponsored by CONRAD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 86 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety of the TFV/LNG intravaginal ring (IVR), TFV-only IVR, and placebo IVR, evaluate pharmacokinetics (PK) of TFV and LNG, evaluate pharmacodynamic (PD) surrogates of contraceptive efficacy of LNG, and to evaluate acceptability of the IVRs.
Interventions
- DRUG TFV/LNG IVR
- DRUG TFV IVR
- OTHER Placebo IVR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02235662
The ClinicalTrials.gov registry entry for NCT02235662 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 86 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 3 interventions - of which TFV/LNG IVR is the first listed.
NCT02235662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02235662 about?
NCT02235662 is a clinical study titled "Phase I One-month Safety, PK, PD, and Acceptability Study of IVR Releasing TFV and LNG or TFV Alone". The purpose of the study is to evaluate the safety of the TFV/LNG intravaginal ring (IVR), TFV-only IVR, and placebo IVR, evaluate pharmacokinetics (PK) of TFV and LNG, evaluate pharmacodynamic (PD) surrogates of contraceptive efficacy of LNG, and to evaluate acceptability of the IVRs.
What is the current status of trial NCT02235662?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2014-10. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02235662?
The interventions under investigation include: TFV/LNG IVR (DRUG), TFV IVR (DRUG), Placebo IVR (OTHER).
Who is sponsoring clinical trial NCT02235662?
This trial is sponsored by CONRAD, which has 33 total clinical trials registered on ClinicalTrials.gov.
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