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Menstrual Cups for Vaginal Infections (POWWERHealth Trial)

Phase 2

Recruiting

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

POWWERHealth Trial Summary

This trial aims to reduce bacterial vaginosis and STIs in Kenyan women at high risk of HIV with the use of menstrual cups. It will also measure the safety & impact of menstrual cups on vaginal microbiome.

Who is the study for?

This trial is for women aged 15-35 in Kisumu County, Kenya who are not pregnant, post-menopausal, or within six months postnatal. Participants must have had a menstrual period in the last two months and rely on sex for livelihood. They should be able to give informed consent and not currently use an IUD.Check my eligibility

What is being tested?

The study tests if using menstrual cups can reduce bacterial vaginosis (BV) and sexually transmitted infections (STIs) among economically vulnerable women at high risk of STIs/HIV. The goal is to see a 25% reduction in BV over one year while assessing safety and implementation needs.See study design

What are the potential side effects?

Potential side effects may include discomfort or irritation from the menstrual cup use. However, since this is a non-drug intervention, fewer side effects are expected compared to medicinal treatments.

POWWERHealth Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the impact of menstrual cups on BV

Secondary outcome measures

Evaluate the impact of menstrual cups on STI

Evaluate the impact of menstrual cups on vaginal microbiome (VMB)

POWWERHealth Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention ArmExperimental Treatment1 Intervention

After completing 12 months observation of usual practices of menstrual hygiene management, all participants will be provided reusable menstrual cups that can be worn during sex. The menstrual cup training is comprised of a 2 hour group session that covers basic information on reproductive health, menstrual health, and menstrual hygiene, cup use (insertion/removal), storage, cleaning. In the first three months after intervention delivery, there are monthly phone calls to assess usage and for trouble shooting. There are 12 months of observation in the menstrual cup arm, with Bacterial vaginosis (BV) and vaginal microbiome (VMB) assessment at the beginning of the 12-month period, at 6 months, and at 12 months. Sexually transmitted infection (STI) is measured at the beginning of the 12- month intervention period, and then at 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Menstrual Cup

2017

N/A

~4140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,099 Total Patients Enrolled

Nyanza Reproductive Health SocietyOTHER

3 Previous Clinical Trials

1,283 Total Patients Enrolled

Liverpool School of Tropical MedicineOTHER

85 Previous Clinical Trials

717,708 Total Patients Enrolled

Media Library

Menstrual Cup (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05666778 — Phase 2

Bacterial Vaginosis Research Study Groups: Intervention Arm

Bacterial Vaginosis Clinical Trial 2023: Menstrual Cup Highlights & Side Effects. Trial Name: NCT05666778 — Phase 2

Menstrual Cup (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05666778 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experimental protocol open to individuals aged 30 and above?

"This medical trial seeks volunteers aged between 15 and 35 years old."

Answered by AI

What criteria must a potential participant meet to be considered for this experiment?

"To be eligible for this study, participants must have bacterial vaginosis and fit within the specified age range of 15 to 35. The research team is targeting a total pool size of 402 patients."

Answered by AI

What regulatory approval has been granted for this intervention?

"The safety of the proposed treatment is assessed as a 2, since there are some studies which demonstrate its security but none that attest to its efficacy."

Answered by AI

What is the sample size of this experiment?

"Affirmative. According to the information available on clinicaltrials.gov, this trial - initially posted February 13th 2023 and most recently adjusted April 28th of the same year - is now actively enrolling patients. Specifically, 402 individuals are required for 2 different locations."

Answered by AI

Are there still opportunities to participate in this experiment?

"The research project, which was initially advertised on February 13th 2023 is still recruiting participants. This information has been corroborated with the most recent update to clinicaltrials.gov on April 28th of this year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs

2023. "Single Arm Trial of Menstrual Cups Among Economically Vulnerable Women to Reduce Bacterial Vaginosis and STIs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05666778.