A Clinical Study of Chinese Herbal Formula TJAOA103 in Treating Genitourinary Syndrome of Menopause
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age45-70
SponsorTongji Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TJAOA103
Treatment groups
113 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov