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NCT05666778 · ClinicalTrials.gov registry record · Phase 2
Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs
A Phase 2 study of Bacterial Vaginosis and Chlamydia Trachomatis Infection, sponsored by Rush University Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 408
- Enrollment target
- 2
- Study locations
NCT05666778 is a Phase 2 study of Bacterial Vaginosis and Chlamydia Trachomatis Infection that is active but no longer recruiting, run by Rush University Medical Center. The registered enrollment target is 408 participants, above the 311-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (31% higher). The trial reports 2 study locations across 2 states.
The verdict
NCT05666778, a Phase 2 study of Bacterial Vaginosis and Chlamydia Trachomatis Infection, is active but no longer recruiting, sponsored by Rush University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 408 participants
- Enrollment target
- 2
- Study locations
Study Summary
HIV remains a global pandemic with 37 million infected. In western Kenya, 16% of women in the general population and 29% of the poorest women have HIV. The HIV and sexually transmitted infection (STI) epidemics overlap with broader reproductive health concerns. Menstrual hygiene management is a big problem in low- and middle-income countries and a lack of menstrual products negatively impacts women's work-life. This comes from cultural taboos, stigma, and discrimination, promoting secrecy around menstruation, high cost of menstrual products, use of traditional materials (e.g. rags, cotton wool, etc.) causing leakage and odor, and lack of water and safe hygiene facilities. Menstrual cups designed for use during sex may help women prevent Bacterial vaginosis (BV) and STIs through hygienic period practices, and may help them avoid bad practices in an attempt to maintain vaginal dryness. The goal of this interventional trial is to test the impact of menstrual cups on vaginal microbiome, BV, and STIs of poor women at high risk for STIs and HIV. We predict to see 25% less BV, our primary outcome, over one year. This trial aims to learn more about the safety of the intervention, and understand what is needed to fully implement the program.
Conditions Studied
Interventions
- DEVICE Menstrual Cup
Study Locations (2)
Illinois
- Rush University Medical Center - Chicago
Nyanza
- Nyanza Reproductive Health Society - Kisumu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 408 participants |
| Start Date | 2023-02-13 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05666778
The ClinicalTrials.gov registry entry for NCT05666778 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 408 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 311-participant average among 15 other Bacterial Vaginosis trials with a reported enrollment target (31% higher). The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Bacterial Vaginosis appearing as the primary indexed condition, and to 1 intervention - of which Menstrual Cup is the first listed.
NCT05666778 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Illinois, Nyanza.
Frequently Asked Questions
What is clinical trial NCT05666778 about?
NCT05666778 is a clinical study titled "Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs". HIV remains a global pandemic with 37 million infected. In western Kenya, 16% of women in the general population and 29% of the poorest women have HIV. The HIV and sexually transmitted infection (STI) epidemics overlap with broader reproductive health concerns. Menstrual hygiene management is a big ...
What is the current status of trial NCT05666778?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 408 participants. The study started on 2023-02-13. Estimated completion is 2027-07-31.
What conditions does trial NCT05666778 study?
This clinical trial studies the following conditions: Bacterial Vaginosis, Chlamydia Trachomatis Infection, Trichomonas Vaginitis, Neisseria Gonorrheae Infection, Vaginal Microbiome.
What interventions are being tested in trial NCT05666778?
The interventions under investigation include: Menstrual Cup (DEVICE).
Who is sponsoring clinical trial NCT05666778?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05666778 being conducted?
This trial has 2 study locations across Illinois, Nyanza. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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