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A Clinical Study of Chinese Herbal Formula TJAOA103 in Treating Genitourinary Syndrome of Menopause

NCT07160127 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2025-09-17

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if Chinese herbal formula TJAOA103 works to treat genitourinary syndrome of menopause (GSM). It will also learn about the safety of TJAOA103. The main questions it aims to answer are:

1. Does TJAOA103 alleviate the symptoms of GSM in participants or have any other benefits?
2. What medical problems do participants have when taking TJAOA103? Researchers will conduct a pre-post comparison to see if TJAOA103 works to treat GSM.

Participants will:

1. Take TJAOA103 twice daily for 4 to 12 weeks.
2. Complete the tests and/or questionnaires on schedule through online follow-up or outpatient visits.
3. Record their use of TJAOA103 and any adverse events.

Conditions

  • Genitourinary Syndrome of Menopause (GSM)

Interventions

DRUG

TJAOA103

Once enrolled, participants will be administered TJAOA103 for 4 to 12 weeks. TJAOA103 should be taken orally twice a day, one sack each time. Dissolve it in about 200 mL of warm water and drink it all. Participants can take it half an hour before breakfast in the morning and half an hour before bedtime in the evening.

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-06-15
Completion
2027-09-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07160127 on ClinicalTrials.gov