Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
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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