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.
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；
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;
Parallel
BPR-101 capsules:Investigational product for the treatment of BV
Drugadministered vaginally and orally as per study protocol.
Placebo：matching the investigational product in appearance, dosage form, and route of administration
Other interventionadministered vaginally and orally as per study protocol.
The recurrence rate of BV
Nugent score + Amsel's test; any positive result indicates a relapse
The recurrence rate of BV
The cure rate of BV
The recurrence rate of BV in cured patients
The time from the last dose of trial medication to the first recurrence of BV
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This trial is not recruiting at the moment. You can still explore other options:
