Postmenopausal vaginal atrophy vaginal atrophy
Conditions
Interventions
The participant took the medicine by insert it into vagina.
Each individual would take the medicine everyday during the first 14 days and would continue taking them twice a week in the next 10 weeks,
Active Comparator Drug,Active Comparator Drug
estradiol hemihydrate with doses of 12.5 microgram vaginally,estradiol hemihydrate with doses of 12.5 microgram vaginally
Sponsors
Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
Female
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Postmenopausal women aged 45 years older 2.Who were amenorrhea for 12 months or who had undergone bilateral oophorectomy since 6 weeks or more 3.Vaginal symptoms related to postmenopausal status (vaginal dryness, vaginal or vulvar irritation, vaginal soreness, vaginal discharge, and/or dyspareunia). 4.Endometrial thickness no more than 5 mm as measured by transvaginal ultrasonography among women with uterus 5.Normal cervical cytology within 3 years 6.Informed consent
Exclusion criteria
Exclusion criteria: 1.Known or suspected history of breast cancer 2.Abnormal uterine bleeding with unknown cause 3.Thromboembolism 4.Hypersensitivity to the study medication or ingredient 5.Previous hormone use within 90 days 6.Genital tract infection 7.Cardiovascular disease 8.Liver disease or gallbladder disease 9.Denied to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaginal maturation value 12 week vaginal maturation index | — |
Secondary
| Measure | Time frame |
|---|---|
| MBS score 12 week MBS score,vaginal pH 12 weeks vaginal pH,VHI 12 week VHI,FSFI 12 week FSFI,serum estradiol level 12 weeks serum estradiol level,endometrium thickness 12 weeks endometrium thickness | — |
Countries
Thailand
Contacts
Public ContactArphamart Nanthiphatthanachai
Faculty of Medicine Siriraj Hospital
Outcome results
None listed