Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
Study NCT ID:
NCT06759350
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2024-12-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'To eliminate researcher bias, a third research participant will place the capsules containing the soy isoflavonate in one bottle and the placebo in another bottle. The bottles will be labeled as group A and group B, but the researchers will not know which is in which group, to ensure that the study intervention and the control/placebo are as indistinguishable as possible to the participants.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'double-blind, efficacy, parallel-group, superiority, randomized clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2024-12-29', 'studyFirstSubmitQcDate': '2025-01-03', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MENCAV', 'timeFrame': 'One month from the first intervention until 6 months', 'description': 'Change in MENCAV questionnaire scores, with 37 items likert type scale, the lowest point is zero and the maximun is 259 points'}], 'secondaryOutcomes': [{'measure': 'D-dimer', 'timeFrame': 'One month from the first intervention until 6 months', 'description': 'Changes in D-dimer values'}, {'measure': 'side effects', 'timeFrame': 'One month from the first intervention until 6 months', 'description': 'incidence of side effects of soy isoflavones.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['menopause', 'Menopausal Women', 'Soy isoflavone effect', 'Quality of life'], 'conditions': ['Menopause', 'Menopausal Women', 'Soy Isoflavone Effect', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '33809928', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Submission of a signed and dated informed consent form.\n* Declared willingness to comply with all study procedures and availability for the duration of the study.\n* Can read and write\n* Female, age 45 to 65 years\n* Female with more than 1 year of amenorrhea.\n* No hormone replacement therapy or herbal medications in the 6 months prior to the investigation.\n* Ability to take oral medication and willing to comply with the \\<study intervention regimen.\n* Agreement to comply with Lifestyle Considerations for the duration of the study.\n* Have a smartphone-type cell phone\n* Residence in Francisco Morazán\n\nExclusion Criteria:\n\n* Patient does not sign informed consent\n* Patient does not wish to participate\n* History of thrombo embolism\n* History of cardiovascular disease\n* Presence of estrogen-dependent neoplasm\n* Presence of abnormal genital bleeding\n* Uncontrolled metabolic diseases\n* Smoking and drinking habits\n* Use of anticoagulant or acetylsalicylic acid\n* Known allergic reactions to soy isoflavonate components\n* 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.'}, 'identificationModule': {'nctId': 'NCT06759350', 'acronym': 'FLAVOCAV', 'briefTitle': 'Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Nacional Autonoma de Honduras'}, 'officialTitle': 'Soy Isoflavonates Versus Placebo on Quality of Life in Menopausal Women: Randomized Double-blind Clinical Trial: FLAVOCAV TRIAL', 'orgStudyIdInfo': {'id': 'PGO-UNAH-48-3-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU.', 'interventionNames': ['Dietary Supplement: Soy isoflavone supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': '2 placebo capsules containing a multivitamin compound.', 'interventionNames': ['Other: Control (placebo) group']}], 'interventions': [{'name': 'Soy isoflavone supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules containing 10 mg natural tocotrienols, 40 mg soy isoflavonoids, 540 mg calcium, vitamin D IU.', 'armGroupLabels': ['Intervention']}, {'name': 'Control (placebo) group', 'type': 'OTHER', 'otherNames': ['Multivitamin compound'], 'description': '2 placebo capsules containing a multivitamin compound.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11101', 'city': 'Tegucigalpa', 'state': 'FM', 'country': 'Honduras', 'facility': 'Hospital Escuela', 'geoPoint': {'lat': 14.0818, 'lon': -87.20681}}], 'overallOfficials': [{'name': 'Ricardo A. Gutierrez Ramirez, MD, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad Nacional Autonoma de Honduras'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It is not necessary, none of the 18 HIPAA identifiers will be placed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Nacional Autonoma de Honduras', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Titular professor', 'investigatorFullName': 'Ricardo A Gutierrez Ramirez, MD, MSc, FACOG', 'investigatorAffiliation': 'Universidad Nacional Autonoma de Honduras'}}}}