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A Crossover Study Evaluating 3 Non-medicated Silicone IVRs

NCT05128136 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-02-09

No results posted yet for this study

Summary

The overall aim of this study is to assess different external diameters of intravaginal rings (IVRs) for adherence, preference, and acceptability. To assess these domains, women in male-partnered relationships will use three different size IVRs.

Conditions

  • Hiv
  • Pregnancy Related

Interventions

DEVICE

Impact of ring size on adherence

The study design is a randomized, open-label, parallel group 3-way crossover study comparing adherence, preference and overall acceptability of 3 different-sized placebo IVRs (IVRs A, B and C) in 24 US couples. At enrollment, each couple will be randomly assigned to 1 of 6 sequences of IVR use: A-B-C, A-C-B, B-A-C, B-C-A, C-A-B or C-B-A. Each couple will use each of the 3 IVRs (IVRs A, B and C) for 30 days per IVR, 90 days total.

Sponsors & Collaborators

  • Albert Einstein College of Medicine

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • Population Council

    lead OTHER

Principal Investigators

  • Barbara Friedland, MPH · Population Council

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2022-12-31
Completion
2023-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05128136 on ClinicalTrials.gov