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Could a simple cup cut STIs and BV? new trial hopes so

NCT ID NCT05666778

Disease control Sponsor: Rush University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This study tests whether giving menstrual cups to economically vulnerable women in Kenya can lower rates of bacterial vaginosis (BV) and sexually transmitted infections (STIs). The cup is a reusable silicone device that collects menstrual blood and can be worn during sex. Researchers will track 408 women for up to three years to see if using the cup leads to a 25% drop in BV and fewer STIs like chlamydia and gonorrhea.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Menstrual cup (reusable silicone device)
What this could lead to
If it works, this could offer a low-cost, reusable tool to reduce bacterial vaginosis and sexually transmitted infections in vulnerable women.
What could go wrong
This is a single-arm trial with no comparison group, so results may be less reliable. The study is still early (Phase 2) and focused on a specific population in Kenya, so findings may not apply elsewhere.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

408 people

The number who actually took part.

Started

Feb 2023

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 35 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * age 15-35 years, * able to provide informed consent, * residing in Kisumu County, * not currently pregnant, * has experienced a menstrual period in the past 2 months, and * dependent on sex for livelihood as defined above. Exclusion Criteria: * pregnancy, * post-natal (within 6 months), * post-menopausal, * amenorrhea, * IUD in situ.

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Conditions

The condition(s) this trial relates to.

bacterial vaginosis chlamydia trachomatis infectious disease gonorrhea Trichomonas vaginitis urogenital infection trichomoniasis sexually transmitted disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bacterial vaginosis Chlamydia trachomatis infection Neisseria gonorrheae infection Trichomonas vaginitis Vaginal microbiome

Contacts and locations

Locations

  • Nyanza Reproductive Health Society

    Kisumu, Nyanza, Kenya

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

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