A Clinical Study of Chinese Herbal Formula TJAOA103 in Treating Genitourinary Syndrome of Menopause (NCT07160127) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
A Clinical Study of Chinese Herbal Formula TJAOA103 in Treating Genitourinary Syndrome of Menopause
China113 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range45 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
severity of the most bothersome symptom (MBS)
Timeframe: From enrollment to the end of treatment at 4 or 12 weeks