Menstrual Cups for Vaginal Infections

(POWWERHealth Trial)

Not currently recruiting at 1 trial location

Overseen By Fredrick Otieno, DCMA, PhD

Age: < 65

Sex: Female

Trial Phase: Phase 2

Sponsor: Rush University Medical Center

Disqualifiers: Pregnancy, Post-natal, IUD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether menstrual cups can help prevent vaginal infections, such as bacterial vaginosis (BV) and sexually transmitted infections (STIs), in women at high risk. Participants will first maintain their usual menstrual hygiene practices for a year, then use menstrual cups for another year while researchers monitor changes in vaginal health. Women living in Kisumu County who rely on sex for income and have menstruated in the past two months may be eligible to join. The goal is to determine if menstrual cups can reduce BV by 25% over a year and improve overall vaginal health. As a Phase 2 trial, this research focuses on measuring the effectiveness of menstrual cups in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that menstrual cups are safe for use during sex?

Research has shown that menstrual cups are generally safe for period care. Studies have found that they do not affect the natural balance in the vagina, such as pH levels or healthy bacteria, meaning they do not interfere with the body's natural defenses. Additionally, another study found that menstrual cups do not cause sexually transmitted infections or vaginal infections like bacterial vaginosis.

In fact, using menstrual cups might even reduce the risk of infections. Specifically, one study showed a 26% lower risk of bacterial vaginosis for those using menstrual cups. These findings suggest that menstrual cups are well-tolerated and might even help improve vaginal health. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about using menstrual cups for vaginal infections because they offer a unique approach compared to typical treatments like antibiotics. Unlike traditional methods, which often involve oral or topical medications, menstrual cups provide a non-invasive way to manage menstrual hygiene while potentially influencing vaginal health. These cups can be worn during sex and may alter the vaginal microbiome, which could help reduce the incidence of bacterial vaginosis and other infections over time. Additionally, menstrual cups are reusable, making them a sustainable and cost-effective option for menstrual health management.

What evidence suggests that menstrual cups are effective for preventing vaginal infections?

Research has shown that menstrual cups, which participants in this trial will receive after a 12-month observation period, can lower the risk of bacterial vaginosis (BV), a common vaginal infection. One study found that people using menstrual cups were 26% less likely to develop BV compared to those who did not use them. Menstrual cups can also enhance vaginal health by increasing beneficial bacteria like Lactobacillus crispatus. These findings suggest that menstrual cups might offer a hygienic option that helps prevent infections and improve overall vaginal health. Using menstrual cups may help women avoid practices that could lead to infections. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My job does not depend on my gender.

Residing in Kisumu County

Able to provide informed consent

Exclusion Criteria

IUD in situ

Pregnancy

I have gone through menopause.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Participants are observed for 12 months using their usual menstrual hygiene management practices

12 months

Monthly phone calls for assessment and troubleshooting

Intervention

Participants receive reusable menstrual cups and are trained on their use, with assessments at baseline, 6 months, and 12 months

12 months

3 visits (in-person) for assessments at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Menstrual Cup

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Nyanza Reproductive Health Society

Collaborator

Trials

5

Recruited

4,600+

Liverpool School of Tropical Medicine

Collaborator

Trials

96

Recruited

804,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10368270/

Analysis of bacterial vaginosis, the vaginal microbiome, and ... Menstrual cups with BV and STI testing and treatment benefitted adolescent schoolgirls through lower occurrence of BV and higher L. crispatus compared with only ...

2. publichealth.uic.edu publichealth.uic.edu/news-stories/menstrual-cups-can-help-prevent-infection-improve-vaginal-health/

Menstrual cups can help prevent infection, improve vaginal ... At the end of the study, the girls with menstrual cups were 26% less likely to have bacterial vaginosis and were 37% more likely to have an ...

3. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004258

Analysis of bacterial vaginosis, the vaginal microbiome, and ... Menstrual cups with BV and STI testing and treatment benefitted adolescent schoolgirls through lower occurrence of BV and higher L. crispatus.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05666778

Single Arm Trial of Menstrual Cups Among Economically ... 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.

5. verixiv.org verixiv.org/articles/2-344

Characterizing menstrual cup microbiomes and their... This study sought to comprehensively characterize the menstrual cup microbiome, identify factors associated with putative pathogens, and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2352396422005217

Safety assessment scheme for menstrual cups and ... Specifically, they were tested to be free from sexually transmitted and vaginal infections (bacterial vaginosis, Candida spp., Trichomonas vaginalis ...