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

NCT07160127 | Not Yet Recruiting Early Phase 1

• 1 other identifier: TJ-IRB202508073-GSM
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does TJAOA103 alleviate the symptoms of GSM in participants or have any other benefits?
2. 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.
3. 3.Take TJAOA103 twice daily for 4 to 12 weeks.
4. 4.Complete the tests and/or questionnaires on schedule through online follow-up or outpatient visits.
5. 5.Record their use of TJAOA103 and any adverse events.

Conditions

Genitourinary Syndrome of Menopause (GSM)

Keywords

Genitourinary Syndrome of Menopause; Traditional Chinise Medicine

Outcome Measures

Primary Outcomes (1)

• severity of the most bothersome symptom (MBS)

  The MBS is derived from a selected list of common GSM symptoms, including vulvovaginal dryness, vulvovaginal itching/irritation, vulvovaginal burning/pain, dyspareunia, and dysuria/urinary frequency/urgency. At baseline, participants will be instructed to rate the severity of each symptom as absent (0), mild (1), moderate (2), or severe (3). They will then be asked to select a single MBS among those symptoms they classify as moderate or severe (i.e., a score ≥ 2). The MBS will be tracked through to the end of treatment, and the changes in its severity will be used to assess symptomatic improvement.

  From enrollment to the end of treatment at 4 or 12 weeks

Secondary Outcomes (8)

• total score of GSM symptoms

  From enrollment to the end of treatment at 4 or 12 weeks

• score for a specific GSM symptom

  From enrollment to the end of treatment at 4 or 12 weeks

• Vaginal Health Index Score (VHIS)

  From enrollment to the end of treatment at 4 or 12 weeks

• vaginal pH

  From enrollment to the end of treatment at 4 or 12 weeks

• Female Sexual Function Index-6 (FSFI-6)

  From enrollment to the end of treatment at 4 or 12 weeks

Study Arms (1)

TJAOA103

EXPERIMENTAL

Once enrolled, participants will be administered TJAOA103 for 4 to 12 weeks.

Drug: TJAOA103

Interventions

TJAOA103 DRUG

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.

TJAOA103

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females aged 45-70 years during the menopausal transition or postmenopausal period.
• Presence of at least one moderate-to-severe (score ≥ 2) symptom of GSM, including vulvovaginal dryness, or vulvovaginal itching/irritation, or vulvovaginal burning/pain, or dyspareunia, or dysuria/urinary frequency/urgency.
• Willing to participate in this trial and sign a written informed consent form.

You may not qualify if:

• Acute or recurrent genitourinary infection.
• Acute or chronic dermatosis of the vulva or vagina.
• A grade 3 or higher degree of prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
• Unexplained abnormal uterine bleeding.
• Ovarian/adnexal mass ≥ 4 cm, or adenomyosis, or adenomyoma/uterine myoma ≥ 4 cm.
• Breast Imaging Reporting and Data System (BI-RADS) classification of breast ultrasound ≥ 4.
• Presence of precancerous lesions or diagnosed malignancy.
• Liver or kidney function indicators (ALT, AST, Urea, Cr) exceeding the upper limits of reference ranges upon repeated testing.
• Severe primary diseases of the nervous, circulatory, respiratory, digestive, urinary or hematopoietic systems; or mental diseases;
• Known allergy to any specific ingredient of the trial drugs.
• Systemic hormone therapy within the past 2 months.
• Application of vaginal moisturizers, lubricants, hormone preparations, or alternative therapies for GSM within the past month.
• Current participation in another clinical trial or participation in another trial within the past month.
• Unwillingness to discontinue the use of moisturizers, lubricants, or any form of hormonal drugs during the trial.
• Other conditions deemed unsuitable for participation by the investigators.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

Central Study Contacts

Jinjin Zhang, Associate Professor

CONTACT

+8613469995233; jinjinzhang@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

CN (1)