Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women

Not Applicable

Recruiting

• Conditions: Menopause; Menopausal Women; Soy Isoflavone Effect; Quality of Life

• Registration Number: NCT06759350
• Lead Sponsor: Universidad Nacional Autonoma de Honduras

Brief Summary

Within the context of the proposed research study, the effect of soy isoflavonoid supplements on the quality of life and coagulation of menopausal women. It has been observed that menopause, as a physiological process, is associated with alterations in the physical, mental and sexual quality of life, making the use of hormone replacement therapy necessary; however, hormone therapy is associated with hypercoagulability, since it has been seen that women have higher levels of thrombogenic microvesicles such as: platelets with a greater probability of causing blood clotting were more likely to present a greater amount of white matter hyperintensities, which appear in the MRI scan.

Detailed Description

The following study is aimed at clarifying the effects of soy isoflavonate supplements on the quality of life and markers of hypercoagulability in menopausal women. The reasons for conducting this research arise from the concern of minimizing side effects such as hypercoagulation caused by hormone replacement therapy, which is intended to be replaced with soy isoflavonates to evaluate its efficacy.

Study Timeline

• Study First Submitted: 2024-12-29
• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-03
• Study First Posted: 2025-01-06
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-07-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Submission of a signed and dated informed consent form.
• Declared willingness to comply with all study procedures and availability for the duration of the study.
• Can read and write
• Female, age 45 to 65 years
• Female with more than 1 year of amenorrhea.
• No hormone replacement therapy or herbal medications in the 6 months prior to the investigation.
• Ability to take oral medication and willing to comply with the <study intervention regimen.
• Agreement to comply with Lifestyle Considerations for the duration of the study.
• Have a smartphone-type cell phone
• Residence in Francisco Morazán

Exclusion Criteria

• Patient does not sign informed consent
• Patient does not wish to participate
• History of thrombo embolism
• History of cardiovascular disease
• Presence of estrogen-dependent neoplasm
• Presence of abnormal genital bleeding
• Uncontrolled metabolic diseases
• Smoking and drinking habits
• Use of anticoagulant or acetylsalicylic acid
• Known allergic reactions to soy isoflavonate components
• History of thrombophilias such as: Antithrombin deficiency, Protein C deficiency, Protein S deficiency, Factor V Leiden, Prothrombin G20210A, Hyperhomocysteinemia, Antiphospholipid syndrome, Acquired activated protein C resistance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MENCAV	One month from the first intervention until 6 months	Change in MENCAV questionnaire scores, with 37 items likert type scale, the lowest point is zero and the maximun is 259 points

Secondary Outcome Measures

Name	Time	Method
D-dimer	One month from the first intervention until 6 months	Changes in D-dimer values
side effects	One month from the first intervention until 6 months	incidence of side effects of soy isoflavones.

Trial Locations

Locations (1)

Hospital Escuela; 🇭🇳 Tegucigalpa, FM, Honduras