Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-03 @ 6:55 PM
Study NCT ID:
NCT06531668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-01
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Examine the Efficacy of a Supplement to Support Hormone Regulation in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hormone Levels Blood Panel (estradiol, testosterone, DHEA, insulin, and progesterone)', 'timeFrame': 'Baseline (Day 0), Midline (Day 45), and Endline (Day 90)', 'description': 'Measurement of hormone levels. Blood tests will be conducted to evaluate these levels at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period).'}], 'secondaryOutcomes': [{'measure': "Participants' Perceptions of Quality of Life", 'timeFrame': 'Baseline (Day 0), Midline (Day 45), and Endline (Day 90)', 'description': "Evaluation of participants' perceptions of the product's effects on quality of life with a self-reported questionnaire."}, {'measure': "Participants' Mood and Energy Levels using the Visual Analog Scale (VAS)", 'timeFrame': 'Baseline (Day 0), Midline (Day 45), and Endline (Day 90)', 'description': "Assessment of participants' mood and energy levels using the Visual Analog Scale (VAS). These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period)."}, {'measure': "Participants' Monthly Cycle Symptoms using the Menstrual Cycle Symptom Diary (MCSD)", 'timeFrame': 'Baseline (Day 0), Midline (Day 45), and Endline (Day 90)', 'description': "Evaluation of participants' monthly cycle symptoms using the Menstrual Cycle Symptom Diary (MCSD). These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period)."}, {'measure': "Participants' Libido using a Libido Questionnaire", 'timeFrame': 'Baseline (Day 0), Midline (Day 45), and Endline (Day 90)', 'description': "Assessment of participants' libido using a Libido Questionnaire. These assessments will be conducted at Baseline (Day 2-5 of the first menstrual period), Midline (Day 2-5 of the second menstrual period), and Endline (Day 2-5 of the third menstrual period)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Women's Health", 'Menstrual Cycle', 'Estrogen'], 'conditions': ['Hormone Regulation']}, 'descriptionModule': {'briefSummary': "This randomized, triple-blind, placebo-controlled trial will evaluate the efficacy of Live Conscious's Beyond Hormone supplement in regulating hormone production in women. The study involves 50 generally healthy female participants aged 25-45 who are not menopausal. The trial spans three menstrual cycles and assesses both objective hormone levels and subjective well-being through blood tests and questionnaires, respectively."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female at-birth, aged 25-45.\n* Not menopausal or perimenopausal.\n* Regularly menstruating.\n* Not taking any medication, supplement, or vitamin affecting hormone levels.\n* Generally healthy and not living with any uncontrolled chronic disease.\n\nExclusion Criteria:\n\n* Medical conditions or treatments affecting hormonal regulation.\n* Endocrine disorders, gynecological or reproductive health conditions.\n* Use of hormonal contraceptives or hormone therapy.\n* Recent major illness or surgery.\n* Severe allergies or hypersensitivities.'}, 'identificationModule': {'nctId': 'NCT06531668', 'briefTitle': 'A Clinical Trial to Examine the Efficacy of a Supplement to Support Hormone Regulation in Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scale Media Inc'}, 'officialTitle': 'A Clinical Trial to Examine the Efficacy of a Supplement to Support Hormone Regulation in Women', 'orgStudyIdInfo': {'id': '20431'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beyond Hormone Supplement', 'description': 'Participants in this arm will receive the Beyond Hormone supplement.', 'interventionNames': ['Dietary Supplement: Beyond Hormone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in this arm will receive a placebo consisting of rice flour encapsulated in a vegetable cellulose capsule.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Beyond Hormone', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will take three capsules once daily with their morning meal for the duration of three menstrual cycles.', 'armGroupLabels': ['Beyond Hormone Supplement']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will take three capsules once daily with their morning meal for the duration of three menstrual cycles.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scale Media Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}