menopausal women who have vulvovaginal atrophy vulvovaginal 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
Conditions
Interventions
ergocalciferol 20000 IU 1 cap po q monday, wednesday, friday * 12 weeks,placebo 1 cap po q monday, wednesday, friday * 12 weeks
Active Comparator Drug,Placebo Comparator No treatment
Sponsors
Maharat Nakhon Ratchasima Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
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/L
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vaginal maturation value 12 weeks VMV was determined from cells collected from the upper one-third of the bilateral vaginal wall using the liquid-based technique and cytologis will report | — |
Secondary
| Measure | Time frame |
|---|---|
| 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),Vaginal pH 0, 6, 12 weeks using acid test strips | — |
Countries
Thailand
Contacts
Public ContactChirocha Hengphrathani
Maharat Nakhon Ratchasima Hospital
Outcome results
None listed