Efficacy and Safety Study of BPR-101 Capsules in Combination With Metronidazole in BV Patients (NCT07483671) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Efficacy and Safety Study of BPR-101 Capsules in Combination With Metronidazole in BV Patients
China80 participantsStarted 2026-04-15
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;