Actively Recruiting

Early Phase 1
Age: 18Years - 49Years
FEMALE
Healthy Volunteers
NCT07039591

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

Led by Population Council · Updated on 2025-09-05

60

Participants Needed

1

Research Sites

64 weeks

Total Duration

On this page

Sponsors

P

Population Council

Lead Sponsor

E

Emory University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 49Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Cisgender female aged 18-49 years old at screening based on self-report
  • Sexually active with penile-vaginal sex at least once a week on average over the past three months with the same male partner and plans to continue at this frequency for at least three months
  • Healthy based on medical history, physical exam, and pelvic exam with visual inspection at screening
  • Using effective non-vaginal contraception (oral contraception, injectable, patch, IUD, sterilization, male condoms)
  • Competent to provide written informed consent
  • Agrees not to participate in other clinical research involving investigational or marketed products during this trial
Not Eligible

You will not qualify if you...

  • Known or suspected allergy to silicone or EVA
  • Positive pregnancy test at screening or enrollment
  • Positive HIV test at screening
  • Presence of clinically significant genital epithelial findings such as abrasions, ulcerations, lacerations, or vesicles at screening
  • Positive test for chlamydia, gonorrhea, or trichomoniasis at screening
  • Symptomatic vulvovaginal candidiasis, bacterial vaginosis, or urinary tract infection at screening
  • Genital abnormalities on visual exam that contraindicate IVR use
  • History of significant uterine or vaginal prolapse or urethral obstruction
  • Unexplained vaginal bleeding within the last three months
  • Currently breastfeeding
  • Partial or complete hysterectomy
  • History of gynecological surgery in the six months prior to screening
  • Within six weeks post abortion or six months postpartum
  • Using vaginal contraception (diaphragm, female condom, spermicide, IVR)
  • Known current drug or alcohol abuse
  • Any condition deemed by clinician to jeopardize participant's health and wellbeing
  • Unable to comply with study requirements including attending all visits and using IVRs as directed
  • Participation in other clinical research trials involving investigational or marketed products currently or within one month prior to screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

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Research Team

I

Irene Bruce

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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