Efficacy and Safety of Vaginal Lactobacillus Dual Probiotic Capsules in Bacterial Vaginosis

Sponsored by Guangdong Longchuangji Pharmaceutical Co., Ltd.

About this trial

Last updated 4 months ago

Study ID

CTS-CO-2666

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18 to 50 Years

Female

Trial Timing

Ended a year ago

What is this trial about?

Primary Objective: To confirm that the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules for bacterial vaginosis (BV) is superior to placebo at the 21-30 day post-treatment visit (Day 21 to Day 30). Key Secondary Objective: To compare the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules versus placebo for BV at the 15-18 day post-treatment visit (Day 15 to Day 18). Other Secondary Objectives: 1) To comprehensively assess the therapeutic efficacy of the study drug versus placebo for BV at Day 15 to 18 and Day 21 to 30; 2) To evaluate the safety profile of the study drug for BV treatment compared with placebo, including adverse events and clinical laboratory findings. Study Design \& Randomization: This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. An independent biostatistician generated the subject and drug randomization lists via SAS software, which were imported into an Interactive Web Response System (IWRS). Investigators at each site obtain randomization and drug numbers through the IWRS for subject allocation. Blinding \& Allocation Concealment: Double-blinding is implemented for both investigators and subjects. The study drug and placebo are identical in appearance, shape, specification, and dosage form. Blinding procedures are performed by personnel unrelated to the trial, with a complete and detailed record of the entire blinding process maintained throughout the study.

What are the participation requirements?

Inclusion Criteria

1. The subjects fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate in the study, and sign an informed consent form before the trial begins;

2. Females aged ≥18 years and ≤50 years, with normal and regular menstrual cycles;

3. Have a history of sexual activity, are willing to undergo vaginal medication, and agree to avoid using other intravaginal products (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) and sexual activity throughout the entire trial period;

4. Clinically diagnosed with Bacterial Vaginosis (BV), requiring the simultaneous satisfaction of all four Amsel criteria:

* Positive clue cells;

* Positive amine (whiff) test;

* Vaginal discharge pH > 4.5;

* Vaginal discharge is homogeneous, thin, and grayish-white in appearance.

5. Nugent score ≥ 7 points.

Exclusion Criteria

1. Known allergy to any component of the investigational drug;

2. Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital tract infections;

3. Presence of vulvovaginitis caused by other infectious etiologies, such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), aerobic vaginitis (AV score ≥3), gonorrhea, Chlamydia trachomatisinfection, etc.;

4. Pelvic examination at screening reveals the presence of condyloma acuminata;

5. History of complicated or recurrent VVC within 1 year prior to screening;

6. Known diagnosis of uterine myoma or adenomyosis requiring interventional treatment, as judged by the investigator;

7. Vaginal speculum examination at screening shows significant vaginal mucosal injury (e.g., mucosal edema, ulceration, erosion);

8. History of significant diseases involving the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine, or psychiatric systems, which in the investigator's judgment may affect participant safety;

9. Use of vaginal douching or other intravaginal treatments (e.g., products like Jie Er Yin, Jie Yin Kang) within 72 hours prior to dosing or anticipated use during the trial period;

10. Received antibiotic or antifungal treatment (systemic and/or intravaginal) within 2 weeks prior to dosing;

11. Current use of long-acting injectable contraceptives or long-acting oral contraceptives at screening;

12. History of gynecological surgery or common procedures that may affect the vaginal microenvironment within 2 months prior to screening (including but not limited to Bartholin's cyst/abscess incision, intrauterine device removal/insertion, cervical or vaginal wall biopsy, cervical conization or loop electrosurgical excision procedure [LEEP]);

13. Virological testing at screening is positive for syphilis or HIV;

14. Positive pregnancy test at screening; or history of pregnancy termination within 2 months prior to screening; or women of childbearing potential who, in the investigator's judgment, cannot use a medically approved, reliable method of contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug;

15. Women who are pregnant or breastfeeding;

16. Participation in other drug or device clinical trials within 3 months prior to dosing, involving the use of investigational drugs or devices;

17. Any other medical condition that, in the investigator's judgment, may interfere with the assessment of this study.