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NCT06163274 · ClinicalTrials.gov registry record · Early Phase 1

Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Rings

A Early Phase 1 study, sponsored by University of Pittsburgh.

Terminated
Registry status
Early Phase 1
Development phase
93
Enrollment target

NCT06163274: Clinical Trial Early Phase 1 study, sponsored by University of Pittsburgh.

NCT06163274 is a Early Phase 1 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 93 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06163274, a Early Phase 1 study, was terminated before completion, sponsored by University of Pittsburgh.

TERMINATED
Registry status
Early Phase 1
Development phase
93 participants
Enrollment target

Study Summary

This research study is being conducted to find out how easy, comfortable, and safe intravaginal rings are for women to use. The two rings used in this study do not dispense any medications, are the same size, but differ in their flexibility and hardness. This study will enroll approximately 100 HIV-negative persons, aged18-45 years, and assigned female sex at birth from sites in the United States, South Africa, and Zimbabwe. Participants will be randomly assigned to use (self-insert) Ring A for 4 weeks and then Ring B for 4 weeks or Ring B first followed by Ring A. There will be a 1-3-week rest period between using the two different rings. The study involves answering questions, undergoing pelvic examinations, and collecting blood and vaginal fluid samples over a total of 7 in-person visits and 2 telephone calls over approximately 9-11 weeks. In addition, both participants and approximately 30 of their sexual partners will be asked to take part in in-depth interviews to further assess acceptability, attitudes, and experiences with ring use to gauge interest in the future use of intravaginal rings as a HIV prevention option.

Primary Outcome

Number of participants that report a preference to use placebo intravaginal Ring A versus Ring B

Interventions

  • DEVICE Placebo Intravaginal Ring A
  • DEVICE Placebo Intravaginal Ring B

Trial Details

FieldValue
Enrollment Target 93 participants
Start Date 2024-02-28
Est. Completion 2025-01-24
Phase Early Phase 1
University of Pittsburgh

1,238 total trials

Why NCT06163274 stopped before completion

NCT06163274 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (75% higher).

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

NCT06163274 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06163274 about?

NCT06163274 is a clinical study titled "Trial to Assess Acceptability and Safety of Two Placebo Intravaginal Rings". This research study is being conducted to find out how easy, comfortable, and safe intravaginal rings are for women to use. The two rings used in this study do not dispense any medications, are the same size, but differ in their flexibility and hardness. This study will enroll approximately 100 HIV-...

What is the current status of trial NCT06163274?

This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 93 participants. The study started on 2024-02-28. Estimated completion is 2025-01-24.

What interventions are being tested in trial NCT06163274?

The interventions under investigation include: Placebo Intravaginal Ring A (DEVICE), Placebo Intravaginal Ring B (DEVICE).

Who is sponsoring clinical trial NCT06163274?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06163274's enrollment target sits among peer trials

93 229th of 2000 higher than 1,772 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early 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 NCT06163274, the US trial registry maintained by the National Library of Medicine. NCT06163274 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.