Phytoestrogens for controlling climacteric symptoms

Phase 4

• Conditions: vasomotor symptoms, psychoemotional symptoms, urogenital symptoms; E28.3

• Registration Number: RBR-76mm75
• Lead Sponsor: ICAMP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: recruitment completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria consisted of postmenopausal women between 40 and 60 years of age who had had their last menstrual period more than 12 months previously, had follicle-stimulating hormone (FSH) levels higher than 30mIU/mL and estradiol levels lower than 20 pg/ml, who were having more than 8 hot flashes in 24 hours, had not been using any form of hormonal treatment during the previous six months and were not currently using any lipid-lowering drugs, antidiabetic drugs, soybean derived products or herbal supplements.

Exclusion Criteria

The exclusion criteria consisted of: previous hysterectomy, chronic gastrointestinal disorder, any contraindication to hormone therapy or patients participating in another clinical trial. Finally, women were excluded if they had a known allergy or hypersensitivity to soy or cow milk or were not willing to cease consumption of soy products for the 16 weeks of the study.

Study & Design

• Study Type: Intervention
• Study Design: Not specified