Effect of estradiol vaginal gel on vaginal atrophy in menopausal women: A randomized control trial
Phase 1
Completed
- Conditions
- -Manopausal woman -Symptom of vaginal atrophy
- Registration Number
- TCTR20170322001
- Lead Sponsor
- a research grant from the Faculty of Medicine Siriraj Hospital, Mahidol University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 80
Inclusion Criteria
-Aged 45 years or older
-Natural menopause/surgical menopause
-Symptom of vaginal atrophy
-TVS reveal endometrial thickness less than 5 mm
-Normal cervical cytology within 3 years
Exclusion Criteria
-Known or suspected histories of breast cancer, cardiovascular disease, liver disease, gallbladder disease
-Genital tract infection
-Abnormal uterine bleeding with unknown cause
-Thromboembolism
-Previous hormonal used within 90 days
-Hypersensitivity to study medication
-All contraindications for administration of estrogen.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective was the mean change from baseline to week 4 and 8 in vaginal maturation value 8 weeks Vaginal maturation value
- Secondary Outcome Measures
Name Time Method the change of VMI, MBS, vaginal pH, VHI, FSFI, serum estradiol level, endometrium thickness 8 weeks VMI, MBS, vaginal pH, VHI, FSFI, serum estradiol level, endometrial thickness