Efficacy and Safety Study of BPR-101 Capsules in Combination With Metronidazole in BV Patients

NCT07483671 | Not Yet Recruiting Phase 2

• 1 other identifier: BT-BPR-101-IIb
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This trial employed a multicenter, randomized, double-blind, parallel, placebo-controlled design to evaluate the preventive effect of BPR-101 capsules combined with metronidazole on the recurrence of BV, as well as the cure rate and safety.

Conditions

Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

• The recurrence rate of BV

  Nugent score + Amsel's test; any positive result indicates a relapse

  Day 90

Secondary Outcomes (5)

• The recurrence rate of BV

  Day 25 and 60

• The cure rate of BV

  Day 15

• The recurrence rate of BV in cured patients

  Day 90

• The time from the last dose of trial medication to the first recurrence of BV

  From the last dose of medication in the trial to the first recurrence of BV

• Adverse events and serious adverse events, vital sign measurements, physical examination, gynecological examination, and laboratory test results (including blood/urine pregnancy test, complete blood count, blood biochemistry, and urinalysis).

  Throughout the research period

Study Arms (2)

Probiotic Group

EXPERIMENTAL

Capsules: Insert the capsule deep into the vagina. Metronidazole: Oral administration.

Drug: BPR-101 capsules:Investigational product for the treatment of BV

Control Group

PLACEBO COMPARATOR

Capsules: Insert the capsule deep into the vagina. Metronidazole: Oral administration.

Other: Placebo：matching the investigational product in appearance, dosage form, and route of administration

Interventions

BPR-101 capsules:Investigational product for the treatment of BV DRUG

administered vaginally and orally as per study protocol.

Probiotic Group

Placebo：matching the investigational product in appearance, dosage form, and route of administration OTHER

administered vaginally and orally as per study protocol.

Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: This study only included female participants.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females aged ≥18 years and ≤50 years, of childbearing age with a history of sexual activity;
• 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；
• Nugent score ≥ 7 points；
• 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；
• Researchers have assessed that the menstrual cycle is regular;
• 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.

You may not qualify if:

• Currently suffering from pelvic inflammatory disease, acute cervicitis, and urinary tract infection requiring intervention, among other acute infections of the genitourinary system;
• Presence of vulvovaginitis caused by other pathogens, which researchers considered to affect trial evaluation, such as aerobic vaginitis (AV), vulvovaginal candidiasis (VVC), and trichomoniasis；
• 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；
• Unexplained abnormal vaginal bleeding within 6 months prior to screening or during the screening visit;
• Those who currently have uterine fibroids, endometrial hyperplasia, endometriosis, or adenomyosis, and for whom researchers believe that intervention is necessary during the trial;
• 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;
• 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;
• Currently using and/or expected to require cimetidine, warfarin (or other anticoagulation therapy) during the trial;
• Products containing alcohol or propylene glycol that are expected to be used within 3 days prior to screening and/or during the trial period;
• 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;
• 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；
• 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);
• Participated in other drug or device clinical trials within 1 month prior to screening and have used the investigational drug or device;
• The researchers believe that the subject has any other circumstances that would make them unsuitable to participate in the trial.

Sponsors & Collaborators

• Chengdu Syncor Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, 300000, China

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Dosage Forms; Drug Administration Routes

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Drug Therapy; Therapeutics

Study Officials

• FengXia Xue, Doctor of Medicine(M.D.)

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke Yao

CONTACT

028-85142721; ke.yao@btyy.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 19, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): January 24, 2027
• Study Completion (Estimated): January 24, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)