Actively Recruiting
A Randomized Open Label Crossover Trial to Assess Performance 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
26 weeks
Total Duration
On this page
Sponsors
P
Population Council
Lead Sponsor
E
Emory University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates the performance and acceptability of three different non-medicated intravaginal rings (IVRs) among sexually active women aged 18 to 49. The study aims to understand how these IVRs, made from different materials, are perceived and tolerated during typical daily activities. The trial is an early phase 1, randomized open-label crossover study focusing on contraceptive usage without medication. Participants will test three types of non-medicated IVRs—two made of silicone and one made of EVA—across two one-day clinic visits. On the first day, women will handle and vaginally insert two rings, performing tasks simulating daily activities; on the second day, they will test the third ring. The study evaluates acceptability using the Intravaginal Ring Acceptability Scale (IVR-AS) over a treatment period of about 13 weeks. Women taking part will undergo screening including medical and pelvic exams to confirm health status and eligibility. During the study, they will be assessed on how acceptable each ring is and how well they perform, with mean acceptability scores measured from enrollment until the end of treatment. Participants must attend all study visits and follow IVR use instructions. The study includes monitoring for safety and adherence, lasting about 13 weeks in total.
CONDITIONS
Brief 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 to 49 years inclusive at screening
- Sexually active with penile-vaginal sex at least once a week over the past three months with the same male partner and plans to continue
- Healthy based on medical history and physical exam including pelvic exam
- Using effective non-vaginal contraception such as oral contraception, injectable, patch, IUD, sterilization, or male condoms
- Able 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 for HIV at screening
- Clinically significant genital epithelial findings such as abrasions, ulcerations, lacerations, or vesicles
- Positive test for chlamydia, gonorrhea, or trichomoniasis at screening
- Symptomatic vulvovaginal candidiasis, bacterial vaginosis, or urinary tract infection at screening
- Genital abnormalities contraindicating 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
- Gynecological surgery within six months prior to screening
- Within six weeks post abortion or six months postpartum
- Using vaginal contraception such as diaphragm, female condom, spermicide, or IVR
- Known current drug or alcohol abuse
- Any condition that may jeopardize health or wellbeing as assessed by clinician
- Unable to comply with study requirements including attending 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
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Approximately 13 weeks
Participants test three non-medicated intravaginal rings on two one-day clinic visits by inserting each ring and performing daily activities with the ring in place.
2 visits (in-person) over 2 days
Trial Site Locations
Total: 1 location
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
I
Irene Bruce
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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