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NCT02006264 · ClinicalTrials.gov registry record · Phase 1

Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring

A Phase 1 study, sponsored by Albert Einstein College of Medicine.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT02006264: Completed Phase 1 study, sponsored by Albert Einstein College of Medicine.

NCT02006264 is a Phase 1 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02006264, a Phase 1 study, has completed, sponsored by Albert Einstein College of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

This prospective, randomized, single-blinded, placebo controlled trial will examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate (TDF) vaginal ring when used continuously for 14 consecutive days. The primary objective is to assess the safety of TDF vaginal rings when used continuously for 14 days by healthy, HIV-uninfected, sexually abstinent women, as compared with a placebo vaginal ring.

Primary Outcome

Grade 1 or higher Genitourinary events as defined by the DAIDS (Division of AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events during the trial period judged to be related to study product

Interventions

  • DRUG TDF Intravaginal Ring
  • DRUG Placebo Intravaginal Ring

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2013-11-19
Est. Completion 2014-11-06
Phase Phase 1
Albert Einstein College of Medicine

175 total trials

What the finished NCT02006264 record still lists

NCT02006264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 2 interventions - of which TDF Intravaginal Ring is the first listed.

NCT02006264 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02006264 about?

NCT02006264 is a clinical study titled "Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring". This prospective, randomized, single-blinded, placebo controlled trial will examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate (TDF) vaginal ring when used continuously for 14 consecutive days. The primary objective is to assess the safety of TDF vaginal ri...

What is the current status of trial NCT02006264?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2013-11-19. Estimated completion is 2014-11-06.

What interventions are being tested in trial NCT02006264?

The interventions under investigation include: TDF Intravaginal Ring (DRUG), Placebo Intravaginal Ring (DRUG).

Who is sponsoring clinical trial NCT02006264?

This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02006264's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 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 NCT02006264, the US trial registry maintained by the National Library of Medicine. NCT02006264 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.