Clinical study to assess the safety and tolerability of live quadruple lactobacillus capsules for vaginal use in subjects with postmenopausal atrophic vaginitis

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100054168

Enrollment

Unknown

Registered

2021-12-10

Start date

2021-12-13

Completion date

Unknown

Last updated

2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal atrophic vaginitis

Interventions

Experimental group:Live quadruple lactobacillus capsules

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women with natural menopause; 2. Diagnosed with PAV symptoms including vaginal dryness, vulvovaginal pain, pruritus, painful intercourse, and have the characteristics of repeated attacks; one or more of the symptoms is the main distress symptoms, and one of the symptoms score is 2 ~ 3 points; 3. AV score >= 4 or Nugent score >= 7 during screening evaluation; 4. Do not use antimicrobial drugs or microbiological drugs without permission during the study; 5. Voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Other reproductive tract infections; 2. Undergone surgical vaginal manipulation, pelvic or cervical-related surgical treatment or vaginal speculum examination showing significant vaginal wall damage within 3 months prior to using the IP; 3. Having serious diseases of respiratory system, circulatory system, endocrine system, digestive system, nervous system, etc., which cannot be effectively controlled; 4. Diabetic patients; 5. Received any vaccine within 7 days prior to using IP; 6. Use estrogen within 3 months; 7. Use antimicrobial drugs and microbial drugs within 7 days before screening; 8. Participated in other drug clinical trials or device clinical trials within 3 months, use of any other intravaginal medicinal product or medical device; 9. Malignant tumors of reproductive system; 10. Allergic to any ingredient in this product and accessories; 11. Unsuitable for the study assessed by investigator.

Design outcomes

Primary

Measure	Time frame
Vital signs;Physical examination;Gynecological examination;Laboratory examination;Liquid based thin-layer cytology;12 lead ECG;Adverse events;	—

Countries

China

Contacts

Public ContactYu Qin

West China Second University Hospital, Sichuan University

yanyangswkj@163.com+86 18980602109

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026