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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: Completed Phase 1 study, sponsored by CONRAD.

NCT02235662 is a Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 86 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Number of treatment-emergent adverse events

Interventions

  • DRUG TFV/LNG IVR
  • DRUG TFV IVR
  • OTHER Placebo IVR

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2014-10
Est. Completion 2015-12
Phase Phase 1
CONRAD

33 total trials

What the finished NCT02235662 record still lists

NCT02235662 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% higher).

The record links to 0 conditions, and to 3 interventions - of which TFV/LNG IVR is the first listed.

NCT02235662 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02235662's enrollment target sits among peer trials

86 652nd of 2000 higher than 1,345 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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Source: ClinicalTrials.gov NCT02235662, the US trial registry maintained by the National Library of Medicine. NCT02235662 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.