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Official title Assess Performance Attributes and Acceptability of Non-medicated Intravaginal Rings Among Sexually Active Women in Atlanta, GA
ClinicalTrials.gov ID: NCT07039591
What this study is testing
- What it's testing
- A randomized open label crossover trial to assess performance attributes and acceptability of non-medicated intravaginal rings among sexually active women in Atlanta, GA
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 49, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
- 6\. Agrees to not participate in any other clinical research involving investigational or marketed products for the duration of this trial.
You likely can't join if
- 1\. Known or suspected allergy to silicone or EVA, as reported by participant. 2. Positive pregnancy test at screening or enrollment based on urine...
- 5\. Positive chlamydia, gonorrhea, or trichomoniasis test at screening. 6. Symptomatic vulvovaginal candidiasis, bacterial vaginosis (BV), or urinary...
- 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...
- 13\. Within six weeks post abortion or six months postpartum, per self-report. 14. Using vaginal contraception (diaphragm, female condom, spermicide...
- 17\. Unable to comply with study requirements, including but not limited to, attending all study visits and using the IVRs as directed.
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 49 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.