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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 is a Early Phase 1 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 93 participants.
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.
Interventions
- DEVICE Placebo Intravaginal Ring A
- DEVICE Placebo Intravaginal Ring B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2024-02-28 |
| Est. Completion | 2025-01-24 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06163274
The ClinicalTrials.gov registry entry for NCT06163274 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Intravaginal Ring A is the first listed.
NCT06163274 reports 0 study locations.
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.
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