Non-medicated intravaginal rings for comfort and acceptability in sexually active women
A Randomized Open Label Crossover Trial to Assess Performance Attributes and Acceptability of Non-medicated Intravaginal Rings Among Sexually Active Women in Atlanta, GA
This study will test non-medicated intravaginal rings to see if sexually active women aged 18–49 find them comfortable and acceptable during regular sex.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | Population Council Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT07039591 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label crossover trial in Atlanta where participants will try pro-type non-medicated intravaginal rings in sequence and report on performance attributes and acceptability. Eligible participants are healthy cisgender women aged 18–49 who have penile-vaginal sex at least once weekly with the same male partner and use a non-vaginal contraceptive method. Screening includes medical and pelvic exams and a pregnancy test, and people with silicone or EVA allergies are excluded. Participants must agree to avoid other investigational products for the trial duration and attend in-person visits at Emory University.
Who should consider this trial
Good fit: Ideal candidates are healthy cisgender women 18–49 who have penile-vaginal sex about once a week with the same male partner, use an effective non-vaginal contraceptive, are not pregnant, and have no silicone/EVA allergy.
Not a fit: People who are pregnant, trying to conceive, not sexually active as defined, have a silicone or EVA allergy, or who need hormonal contraception are unlikely to benefit from this non-medicated device study.
Why it matters
Potential benefit: If successful, the results could inform design of more comfortable, acceptable intravaginal rings that improve user experience and uptake.
How similar studies have performed: Previous acceptability and performance studies of intravaginal rings have reported mixed but generally positive user feedback, though data specifically on non-medicated prototype rings are more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Cisgender female aged 18-49 years old, inclusive, at screening based on self-report. 2\. Sexually active, defined as having penile-vaginal sex at least once a week, on average, over the past three months with the same male partner, and intends to continue having sexual intercourse at the current frequency for at least three months. 3\. Healthy based on medical history, physical exam (including pelvic exam with visual inspection) at screening. 4\. Using effective non-vaginal method of contraception (oral contraception, injectable, patch, IUD, sterilization, male condoms) 5. Competent to provide written informed consent based on Investigator's assessment. 6\. Agrees to not participate in any other clinical research involving investigational or marketed products for the duration of this trial. Exclusion Criteria: * 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. 5\. Positive chlamydia, gonorrhea, or trichomoniasis test at screening. 6. Symptomatic vulvovaginal candidiasis, bacterial vaginosis (BV), or urinary tract infection (UTI) at screening. (Participants who are symptomatic at initial screening will be referred for testing and treatment and may be reconsidered for eligibility after completing treatment and/or if no longer symptomatic). 7\. Presence of genital abnormalities on visual exam with speculum that would contraindicate IVR use. 8\. History of significant uterine or vaginal prolapse, or urethral obstruction. 9. Unexplained vaginal bleeding per self-report within the last three months. 10. Currently breastfeeding per self-report. 11. Partial or complete hysterectomy per self-report. 12. History of gynecological surgery in the six months prior to screening per self-report. 13\. Within six weeks post abortion or six months postpartum, per self-report. 14. Using vaginal contraception (diaphragm, female condom, spermicide, IVR). 15. Known current drug abuse, including illicit drugs, or alcohol abuse. 16. Any other condition the clinician feels would jeopardize the health and wellbeing of the participant after assessing the participant's potential eligibility for the study. 17\. Unable to comply with study requirements, including but not limited to, attending all study visits and using the IVRs as directed. 18\. Participation in any other clinical research trial involving investigational or marketed products currently or within one month of participation prior to screening, including any trial of a spermicide, microbicide and/or drug.
Where this trial is running
Atlanta, Georgia
- Emory University — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Study coordinator: Irene Bruce
- Email: ibruce@popcouncil.org
- Phone: 16468215100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.