Status:
NOT_YET_RECRUITING
A Clinical Study of Chinese Herbal Formula TJAOA103 in Treating Genitourinary Syndrome of Menopause
Lead Sponsor:
Tongji Hospital
Conditions:
Genitourinary Syndrome of Menopause (GSM)
Eligibility:
FEMALE
45-70 years
Phase:
EARLY_PHASE1
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 quest...
Detailed Description
Genitourinary syndrome of menopause (GSM) refers to a collection of symptoms and signs such as atrophy of the genital and urinary tracts and sexual dysfunction in women during the menopausal transitio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2027
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT07160127
Start Date
September 15 2025
End Date
September 15 2027
Last Update
September 17 2025
Active Locations (1)
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1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China