Effects of soy isoflavones on quality of life in menopausal women
Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women: Randomized Double-blind Clinical Trial: FLAVOCAV TRIAL
This study is testing if soy isoflavone supplements can improve the quality of life for menopausal women as an alternative to hormone replacement therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | Female |
| Sponsor | Universidad Nacional Autonoma de Honduras Academic / other |
| Locations | 1 site (Tegucigalpa, FM) |
| Trial ID | NCT06759350 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of soy isoflavone supplements on the quality of life and coagulation markers in menopausal women. It aims to provide an alternative to hormone replacement therapy, which can lead to hypercoagulability and associated risks. Participants will be randomly assigned to receive either the soy isoflavone supplement or a placebo, and their quality of life will be assessed throughout the study. The research seeks to clarify the efficacy of soy isoflavones in improving menopausal symptoms while minimizing side effects.
Who should consider this trial
Good fit: Ideal candidates are women aged 45 to 65 who have experienced menopause for over a year and are not currently on hormone replacement therapy.
Not a fit: Patients with a history of thromboembolism, cardiovascular disease, or those currently using anticoagulants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a safer alternative to hormone replacement therapy for menopausal women, improving their quality of life.
How similar studies have performed: While the use of soy isoflavones has been explored in other studies, this specific approach focusing on quality of life in menopausal women is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tegucigalpa, FM
- Hospital Escuela — Tegucigalpa, Fm, Honduras (Recruiting)
Study contacts
- Study coordinator: Ricardo A. Gutierrez Ramirez, MD, MSc
- Email: ricardo.gutierrez@unah.edu.hn
- Phone: 50497546940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.