Assess Performance Attributes and Acceptability of Non-medicated Intravaginal Rings Among Sexually Active Women in Atlanta, GA

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorPopulation Council

About this trial

A randomized open label crossover trial to assess performance attributes and acceptability of non-medicated intravaginal rings among sexually active women in Atlanta, GA

Eligibility criteria

Qualifiers

1. Cisgender female aged 18-49 years old, inclusive, at screening based on self-report.

Disqualifiers

1. Known or suspected allergy to silicone or EVA, as reported by participant. 2. Positive pregnancy test at screening or enrollment based on urine hCG test. 3. Positive for HIV at screening based on rapid test per site SOPs. 4. Presence of any clinically significant genital epithelial findings (e.g. abrasions, ulcerations, lacerations, or vesicles) at screening.

Trial design

Treatments tested in this trial

  • Pro-type IVR

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

Population Council

Lead sponsor

Emory University

Collaborator