Assess Performance Attributes and Acceptability of Non-medicated Intravaginal Rings Among Sexually Active Women in Atlanta, GA
Launched by POPULATION COUNCIL · Jun 17, 2025
Trial Information
Current as of July 22, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well non-medicated vaginal rings (small, flexible devices placed inside the vagina) work and how comfortable women find them to use. These rings do not contain any medicine or hormones and are being tested among sexually active women in Atlanta, Georgia. The goal is to learn more about the rings’ performance and whether women like using them as a possible option related to contraception.
Women who might be eligible for this study are those between 18 and 49 years old who are healthy, have sex with the same male partner about once a week, and are currently using other effective birth control methods that are not placed inside the vagina (like the pill, patch, or condoms). Participants will need to attend study visits, use the vaginal rings as directed, and agree not to join other research studies during this trial. Women who are pregnant, breastfeeding, have certain infections, allergies to materials in the ring, or recent gynecological surgeries will not be able to join. If you take part, you can expect to have medical exams and be asked about your experience using the rings to help researchers understand how acceptable and practical this option might be.
Gender
FEMALE
Eligibility 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.
About Population Council
The Population Council is a leading nonprofit organization dedicated to advancing health and development through innovative research and evidence-based solutions. With a focus on improving the well-being of individuals and communities, the Council conducts clinical trials and studies that address critical issues in reproductive health, family planning, and HIV prevention. By collaborating with a diverse range of partners, including governments, NGOs, and academic institutions, the Population Council aims to translate scientific findings into effective policies and programs that enhance health outcomes globally. Their commitment to rigorous research and ethical practices positions them as a trusted sponsor in the field of clinical trials.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Atlanta, Georgia, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported