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Completed

NCT Number: NCT06759350

Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women

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.

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Key information

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Escuela

Tegucigalpa, FM, 11101, Honduras

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Soy isoflavone supplement

Dietary Supplement

2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU.

Control (placebo) group

Other

2 placebo capsules containing a multivitamin compound.

Other names: Multivitamin compound

Primary outcomes

  1. MENCAV

    Time frame: 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 outcomes

  1. D-dimer

    Time frame: One month from the first intervention until 6 months

    Changes in D-dimer values

  2. side effects

    Time frame: One month from the first intervention until 6 months

    incidence of side effects of soy isoflavones.

Sponsors and collaborators

Lead sponsor

Universidad Nacional Autonoma de Honduras

Other

Registry information

Official study title

Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women: Randomized Double-blind Clinical Trial: FLAVOCAV TRIAL

Acronym: FLAVOCAV

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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