An Early Phase 1 interventional study of Pro-type IVR in Contraceptive Usage, sponsored by Population Council. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by Population Council · Early Phase 1, Interventional, and Other
A randomized open label crossover trial to assess performance attributes and acceptability of non-medicated intravaginal rings among sexually active women in Atlanta, GA
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's planned enrollment of 60 is below the median of 382 across 106 interventional studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →Population Council is the lead sponsor of 26 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 (oral contraception, injectable, patch, IUD, sterilization, male condoms) 5. Competent to provide written based on Investigator's assessment.
6. Agrees to not participate in any other clinical research involving 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 at screening based on rapid test per site SOPs. 4. Presence of any 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 (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 or marketed products currently or within one month of participation prior to screening, including any trial of a spermicide, microbicide and/or drug.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
60 women comparing acceptability of three different non-medicated IVRs (2 silicone and 1 EVA) based on the Intravaginal Ring Acceptability Scale (IVR-AS).
Device: Pro-type IVR
Women will test three non-medicated IVRs on two one-day clinic visits (two on the first day, one on the second day) by manipulating them, vaginally inserting each ring and then performing a controlled set of tasks simulating routine daily activities with the ring in the vagina.
Mean Acceptability Score per IVR
For the primary outcome we will compute the mean acceptability score per IVR, for each of three IVRs of different compression strengths. The scores women give each of the three rings will be compared using a mixed-effects model with orthogonal contrasts, with all 3 pairwise comparisons using the Bonferroni method to adjust for multiple comparisons.
Time frame: From enrollment to the end of treatment at approximately 13 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Apr 2026, 8 months after the start.
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