None listed
Conditions
Interventions
Intervention1: Isoflavone: 75 mg Daily Orally for 3 months
Control Intervention1: Matched Placebo: Orally daily for 3 months
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: (1). undergone bilateral oophorectomy, (2). less than 55 years of age, (3). baseline thyroid stimulating hormone (TSH) values within the normal range (4). willing to comply with the protocol.
Exclusion criteria
Exclusion criteria: (1) suffering from any thyroid disease, (2) suffering from any autoimmune disorder, (3) already on isoflavones, (4) taken HRT/ estrogen replacement therapy (ERT) within previous 8 weeks, (5) presence of renal and/or hepatic disease, (6) active major psychiatric disorders, (7) history of thrombophlebitis or thromboembolism or cerebrovascular disorders, (8) uncontrolled hypertension with blood pressure > 180/100, (9) uncontrolled diabetes, (10) on any drug which can affect thyroid function, (11) presence of active infection or malignancy and (12) present or past history of soy or nut related food allergies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete serum thyroid profile (Thyroid stimulating hormone, free T3, free T4, Thyroid binding globulin and anti-TPO antibodies)Timepoint: Baseline, 6 and 12 weeks;Complete serum thyroid profile (Thyroid stimulating hormone, free T3, free T4, Thyroid binding globulin and anti-TPO antibodies)Timepoint: Baseline, 6 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Menopause symptom score (MSS), serum follicle stimulating hormone (FSH) and estradiol levelsTimepoint: MSS : 0, 3, 6, 9 & 12 weeks FSH & estradiol levels: 0 & 12 weeks | — |
Countries
India
Contacts
Public ContactDebasish Hota
Assistant Professor in Endocrinology
Outcome results
None listed