A clinical trial to study the effect of isoflavones on thyroid function in oophorectomised women.

Phase 3

Completed

• Registration Number: CTRI/2009/091/000870
• Lead Sponsor: PGIMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2013-12-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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

(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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Menopause symptom score (MSS), <br/ ><br>serum follicle stimulating hormone (FSH) and <br/ ><br>estradiol levelsTimepoint: MSS : 0, 3, 6, 9 & 12 weeks <br/ ><br>FSH & estradiol levels: 0 & 12 weeks