Effects of vaginal erbium laser versus local estrogen for the treatment of genitourinary syndrome of menopause, a randomized controlled trial
Phase 3
- Conditions
- -Menopause-The participant with at least one clinical symptom of genitourinary syndrome of menopause(vaginal dryness,dyspareunia,itching,irritation)Genitourinary syndrome of menopauseVaginal estrogenVaginal laser
- Registration Number
- TCTR20200714006
- Lead Sponsor
- Ratchadapisek sompotch Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- Female
- Target Recruitment
- 98
Inclusion Criteria
1. Natural postmenopause women (more than 12 months of amenorrheic period without other related organic pathologies)
2. Age 45-75 years
3. Women presenting with at least one clinical symptom of genitourinary syndrome of menopause(vaginal dryness, dyspareunia, itching, irritation)
Exclusion Criteria
1. Receive treatment with vaginal moisturizers, vaginal lubricant, vaginal laser, systemic or local estrogens within 90 days before recruitment
2. Pelvic organ prolapse stage 3 or higher
3. BMI of more than 35 kg/m2
4. Vaginal infection within 30 days
5. Any type of vaginal surgery within 90 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vaginal Maturation Index 4,8,112 weeks Vaginal Maturation Index
- Secondary Outcome Measures
Name Time Method patient symptoms(dryness, dyspareunia, ithching, irritation) 12 weeks Visual analogue scale,patient satisfation 12 weeks Visual analogue scale,vaginal health index (VHI) 12 weeks clinical evaluation,adverse effects 12 weeks Bleeding, infection, pain incidence