NCT07039591 · Population Council
Assess Performance Attributes and Acceptability of Non-medicated Intravaginal Rings Among Sexually Active Women in Atlanta, GA
What this study is about
A randomly assigned open label crossover trial to assess performance attributes and acceptability of non-medicated intravaginal rings among sexually active women in Atlanta, GA
View original scientific description
A randomized open label crossover trial to assess performance attributes and acceptability of non-medicated intravaginal rings among sexually active women in Atlanta, GA
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Atlanta, Georgia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 5, 2025 · Source of record for eligibility and locations