Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women

Last updated: August 26, 2025
Sponsor: Universidad Nacional Autonoma de Honduras
Overall Status: Completed

Phase

N/A

Condition

Menopause

Treatment

Control (placebo) group

Soy isoflavone supplement

Clinical Study ID

NCT06759350
PGO-UNAH-48-3-2025
  • Ages 45-65
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Submission of a signed and dated informed consent form.

  • Declared willingness to comply with all study procedures and availability for theduration 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 theinvestigation.

  • Ability to take oral medication and willing to comply with the <study interventionregimen.

  • Agreement to comply with Lifestyle Considerations for the duration of the study.

  • Have a smartphone-type cell phone

  • Residence in Francisco Morazán

Exclusion

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

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Control (placebo) group
Phase:
Study Start date:
February 01, 2025
Estimated Completion Date:
August 01, 2025

Study 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.

Connect with a study center

  • Hospital Escuela

    Tegucigalpa, FM 11101
    Honduras

    Site Not Available

  • Hospital Escuela

    Tegucigalpa 3600949, FM 11101
    Honduras

    Site Not Available

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