Live Double Combined Lactobacillus Capsule for Vaginal Use(IIb) (BV)

Guangdong Longchuangji Pharmaceutical Co., Ltd.

Status and phase: Completed; Phase 2

Conditions: Bacterial Vaginosis

Treatments: Drug: Placebo; Drug: Vaginal Lactobacillus Dual Probiotic Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT07418918

CTS-CO-2417 (Registry Identifier)

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, placebo-controlled phase IIb clinical study, to evaluate the efficacy and safety of the dual - live Lactobacilli-containing vaginal capsule for the treatment of bacterial vaginosis.

Enrollment: 66 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subject fully understands the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participates in the study, and provides written informed consent prior to trial commencement;
2. Female aged 18 to 50 years (inclusive of the boundary values);
3. History of sexual activity, willing to undergo vaginal administration of medication, and agrees to refrain from using other intravaginal products (e.g., contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) and from engaging in sexual activity throughout the entire trial period;
4. Has a normal and regular menstrual cycle;
5. Clinically diagnosed with bacterial vaginosis (BV), defined as having at least three positive findings on Amsel's criteria, including the presence of clue cells (i.e., clue cells accounting for >20% of the total vaginal epithelial cells); and a 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 infection;
3. Vulvovaginitis due to other infectious etiologies, such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), aerobic vaginitis (AV score ≥5), gonorrhea, or Chlamydia trachomatisinfection,etc;
4. Pelvic examination at screening reveals the presence of condyloma acuminata (genital warts);
5. History of complicated or recurrent VVC within 1 year prior to screening;
6. Known diagnosis of uterine fibroids or adenomyosis requiring intervention as assessed by the investigator;
7. Vaginal speculum examination at screening indicates significant vaginal mucosal injury (e.g., mucosal edema, ulceration, erosion);
8. History of significant diseases affecting the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine, or psychiatric systems, which in the investigator's judgment may compromise subject safety;
9. Use of vaginal douching or other intravaginal treatments (e.g., products such as 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 contraceptive injections or oral contraceptives at screening;
12. History of gynecological surgery within 2 months prior to screening;
13. Positive virological tests for syphilis or HIV at screening;
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 and reliable contraceptive method from the time of signing the informed consent until 3 months after the last dose of the study drug;
15. Women who are pregnant or breastfeeding;
16. Participation in any other drug or medical device clinical trial within 3 months prior to dosing, involving the use of investigational drugs or devices; Any other medical condition that, in the investigator's judgment, may affect the assessment of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

Vaginal Lactobacillus Dual Probiotic Capsules

Experimental group

Treatment:

Drug: Vaginal Lactobacillus Dual Probiotic Capsules

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo