Surgical menopause
Conditions
Interventions
The isoflavone preparation used in this study will be the commercial soy isoflavone product (1 tablet contains not less than 30 mg isoflavone genistein,
manufactured by the Faculty of Pharmacy,
Chiang Mai University,
administered 1 tablet twice a day (12 weeks). ,The placebo will be the instant powder,
prepared in an identical appearance and flavor but without soy isoflavones,
administered 1 tablet twice a day (12 weeks).
Soy isoflavone product,Placebo
Sponsors
Chiang Mai University
Department of Pharmacology Faculty of Medicine,
Chiang Mai University
Eligibility
Sex/Gender
Female
Age
30 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Surgical menopause (6 weeks postsurgical bilateral oophorectomy with or without hysterectomy). 2. Age >30 years. 3. Serum follicle-stimulating hormone concentration >35 IU/L. 4. Average of five or more hot flush symptoms per day.
Exclusion criteria
Exclusion criteria: 1. History of chronic renal, liver, pulmonary, cardiovascular or gastrointestinal diseases, thromboembolic disorders, thyroid disease and a history of cardiovascular disease or stroke. 2. Recent cigarette smoking or alcoholic consumption. 3. History of substance abuse or addiction. 4. Use of HRT or oral contraceptives in the past 6 months. 5. Intake of nutritional supplements containing vitamins, minerals, fibers and isoflavones within the previous 2 weeks. 6. Allergy or hypersensitivity to soy or cow milk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hot flushes symptoms Baseline, 4, 8 and 12 weeks Hot flushes Diary | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life Baseline, 4, 8 and 12 weeks The Menopause-Specific Quality of Life (MENQOL) questionnaire,Vaginal cytology Baseline and 12 weeks Maturation Value (MV). | — |
Contacts
Public ContactAssoc. Prof. Dr. Supanimit Teekachunhatean
Department of Pharmacology Faculty of Medicine, Chiang Mai University
Outcome results
None listed