Efficacy of soy isoflavone product on hot flushes symptoms in surgical menopausal wome

Phase 2

Active, not recruiting

• Conditions: Surgical menopause

• Registration Number: TCTR20200622006
• Lead Sponsor: Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-22
• Study Completion: 2021-06-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hot flushes symptoms Baseline, 4, 8 and 12 weeks Hot flushes Diary

Secondary Outcome Measures

Name	Time	Method
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).