MenopauseFLAVOCAVNCT06759350
Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women
A study testing Soy isoflavone supplement in people with Menopause and Menopausal Women, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Menopausal Women, Soy Isoflavone Effect
- What is being tested?
- Soy isoflavone supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteHonduras
- Study dates
- 1 Feb 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women: Randomized Double-blind Clinical Trial: FLAVOCAV TRIAL
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.
Read the 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.
- Conditions
- Menopause, Menopausal Women, Soy Isoflavone Effect, Quality of Life
- Being tested
- Soy isoflavone supplement, Control (placebo) group
- Keywords
- menopause, Menopausal Women, Soy isoflavone effect, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy isoflavone supplementDietary supplement
2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU.
Control (placebo) groupOther
Also called Multivitamin compound
2 placebo capsules containing a multivitamin compound.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU. Receives: Dietary Supplement: Soy isoflavone supplement |
| control | Placebo comparator | 2 placebo capsules containing a multivitamin compound. Receives: Other: Control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
MENCAV
Change in MENCAV questionnaire scores, with 37 items likert type scale, the lowest point is zero and the maximun is 259 points
Measured: One month from the first intervention until 6 months
Secondary outcomes (2)
D-dimer
Changes in D-dimer values
Measured: One month from the first intervention until 6 months
side effects
incidence of side effects of soy isoflavones.
Measured: One month from the first intervention until 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Feb 2025
- Primary completion31 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, efficacy, parallel-group, superiority, randomized clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Honduras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
- Investigators
- Ricardo A. Gutierrez Ramirez, MD, MSc, Study director, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759350
- Sponsor's protocol ID
- PGO-UNAH-48-3-2025
- Acronym
- FLAVOCAV
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not necessary, none of the 18 HIPAA identifiers will be placed
Publications
Chen LR, Chen KH. Utilization of Isoflavones in Soybeans for Women with Menopausal Syndrome: An Overview. Int J Mol Sci. 2021 Mar 22;22(6):3212. doi: 10.3390/ijms22063212.
PubMed 33809928
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women: Randomized Double-blind Clinical Trial: FLAVOCAV TRIAL
- ClinicalTrials.gov ID
- NCT06759350
- Acronym / sponsor ID
- FLAVOCAV / PGO-UNAH-48-3-2025
- Conditions
- Menopause, Menopausal Women, Soy Isoflavone Effect, Quality of Life
- Keywords
- menopause, Menopausal Women, Soy isoflavone effect, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Nacional Autonoma de HondurasUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double-blind, efficacy, parallel-group, superiority, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Soy isoflavone supplement2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU. |
| control | Placebo comparator | Other: Control (placebo) group2 placebo capsules containing a multivitamin compound. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy isoflavone supplement2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU. | Dietary supplement | Intervention |
| Control (placebo) groupAlso: Multivitamin compound2 placebo capsules containing a multivitamin compound. | Other | control |
Primary outcome
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
2 secondary outcomes
D-dimer
Time frame: One month from the first intervention until 6 months
side effects
Time frame: One month from the first intervention until 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 33809928Chen LR, Chen KH. Utilization of Isoflavones in Soybeans for Women with Menopausal Syndrome: An Overview. Int J Mol Sci. 2021 Mar 22;22(6):3212. doi: 10.3390/ijms22063212.
- Individual participant dataSharing planned: No. It is not necessary, none of the 18 HIPAA identifiers will be placed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo A. Gutierrez Ramirez, MD, MSc study director
Universidad Nacional Autonoma de Honduras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy isoflavone supplement in people with Menopause and Menopausal Women, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MENCAV (time frame: One month from the first intervention until 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06759350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.