Efficacy of vitamin D on vulvovaginal atrophy in menopausal wome
Phase 1
Recruiting
- Conditions
- menopausal women who have vulvovaginal atrophyvulvovaginal atrophy, menopausal women , vitamin D, vaginal maturation value, vaginal atrophy symptoms (The most bothersome symptom), modified vaginal health index , vaginal atrophy score , vitamin D level
- Registration Number
- TCTR20231107003
- Lead Sponsor
- Maharat Nakhon Ratchasima Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 48
Inclusion Criteria
1. Women who have vulvovaginal atrophy symptoms, 2. Menopausal women, who absence of menstruation for at least 1 year, 3. Women who previous bilateral oophorectomy, 4. Women who have serum FSH level more than 40 IU/
Exclusion Criteria
1. Women who have history of hormonal or vitamin D treatments or supplement within a previous 12 weeks, 2. Women who have abnormal pap smear, 3. Women who have active sexual transmitted disease, 4. Women who have abnormal uterine bleeding, 5. women who have severe medical condition (e.g. liver failure, renal failure), 6. women who have history of vitamin D or calcium allergy, 7. Unwillingness to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method vaginal maturation value 12 weeks Histological
- Secondary Outcome Measures
Name Time Method vaginal atrophy symptoms (The most bothersome symptom) 0, 6, 12 weeks Patient reported outcome using a questionnaire interview,modified vaginal health index 0, 6, 12 weeks Physical examination,vaginal atrophy score 0, 6, 12 weeks Physical examination,vitamin D level 0, 6, 12 weeks Electrochemiluminescence immunoassay (ECLIA)