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New combo pill aims to end recurring vaginal infections

NCT ID NCT07483671

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether BPR-101 capsules, taken with the antibiotic metronidazole, can prevent bacterial vaginosis (BV) from coming back. Eighty women with BV will receive either the active treatment or a placebo. The main goal is to see if the combination lowers the rate of BV recurrence over time.

What this could mean

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

Active substance
BPR-101 capsules
What this could lead to
If successful, this could lead to a new way to prevent bacterial vaginosis from coming back after treatment.
What could go wrong
This is an early phase IIb trial with only 80 participants, so results may not apply to everyone. The combination therapy might not reduce recurrence as hoped.

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

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Females aged ≥18 years and ≤50 years, of childbearing age with a history of sexual activity; 2. Clinically diagnosed with Bacterial Vaginosis (BV), this test requires meeting at least 3 of the following 4 Amsel criteria (with a positive clue cell test being a mandatory condition): positive clue cells; positive amine test; vaginal discharge pH \> 4.5; and Vaginal discharge is homogeneous, thin, and grayish-white in appearance; 3. Nugent score ≥ 7 points; 4. Vaginal administration is acceptable, and the patient agrees to avoid using any other vaginal products (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) except as specified in the trial throughout the entire trial period; 5. Researchers have assessed that the menstrual cycle is regular; 6. Subjects must voluntarily sign a written informed consent form before the trial, understand the procedures and methods of the trial, and be willing to strictly abide by the clinical trial protocol and complete the trial. Exclusion Criteria: 1. Currently suffering from pelvic inflammatory disease, acute cervicitis, and urinary tract infection requiring intervention, among other acute infections of the genitourinary system; 2. Presence of vulvovaginitis caused by other pathogens, which researchers considered to affect trial evaluation, such as aerobic vaginitis (AV), vulvovaginal candidiasis (VVC), and trichomoniasis; 3. Currently, other vaginal or vulvar diseases are considered by researchers to affect the evaluation of the trial, such as human papillomavirus infection; or gynecological examinations showing condyloma acuminata or genital herpes; 4. Unexplained abnormal vaginal bleeding within 6 months prior to screening or during the screening visit; 5. Those who currently have uterine fibroids, endometrial hyperplasia, endometriosis, or adenomyosis, and for whom researchers believe that intervention is necessary during the trial; 6. Received local or systemic antifungal or antibiotic treatment or probiotic treatment within 2 weeks prior to screening; or vaginal douching or other vaginal treatments (such as Jieeryin, Jieyinkang, etc.) within 1 week prior to screening, and/or expected to receive the above treatments during the trial; 7. Used systemic steroids (oral or injectable), disulfiram, lithium salts within 14 days prior to screening., and/or expected to receive such treatment during the trial; 8. Currently using and/or expected to require cimetidine, warfarin (or other anticoagulation therapy) during the trial; 9. Products containing alcohol or propylene glycol that are expected to be used within 3 days prior to screening and/or during the trial period; 10. Hhistory of malignant tumors within 5 years prior to screening and deemed unsuitable for inclusion by the researchers, except for those with adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ; 11. Hhistory of major gynecological surgery within 6 months prior to screening(deep wounds, long recovery time), or superficial gynecological surgery or common procedures within 60 days prior to screening,or whose screening visit is within 60 days of their last termination of pregnancy; 12. History of or currently suffering from serious diseases of the cardiovascular, liver, kidney, lung, digestive tract, nervous and mental system, genitourinary system, endocrine system, etc., and are deemed unsuitable for inclusion by the researchers; 13. Laboratory tests meeting any of the following criteria, and the investigator deems them unsuitable for inclusion: serum creatinine \> 1.5 times the upper limit of normal (ULN); urea/urea nitrogen \> 1.5 ULN; alanine aminotransferase (ALT) \> 2 ULN; aspartate aminotransferase (AST) \> 2 ULN; 14. Known hypersensitivity to any component of BPR-101 capsules or to other similar drugs (such as Live Lactobacillus Capsule for Vaginal Use ); or nitroimidazole, metronidazole, or any of the excipients; 15. Women who are pregnant or breastfeeding, or whose pregnancy test results are positive, or who plan to become pregnant throughout the trial and within 3 months after the last dose; or who cannot accept the use of reliable contraception (absence of sexual intercourse or barrier contraception with condoms throughout the study period); 16. Participated in other drug or device clinical trials within 1 month prior to screening and have used the investigational drug or device; 17. The researchers believe that the subject has any other circumstances that would make them unsuitable to participate in the trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tianjin Medical University General Hospital

    Tianjin, 300000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.