Ignite Creation Date:
2025-12-25 @ 1:37 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT07117994
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radicle Revive 24: A Study of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Peri-Menopausal Health Issues
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received."}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be stratified then randomized to one of the study arms. Each participant will have an equal chance of being assigned to each study arm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Perceived Stress', 'timeFrame': '6 weeks', 'description': 'Change in perceived stress: Difference between rates of change over time in Perceived Stress score as assessed by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress)'}], 'secondaryOutcomes': [{'measure': 'Change in General Menopausal Health', 'timeFrame': '6 weeks', 'description': 'Change in other menopausal health issues: Other menopausal health issues assessed by Radicle General Menopausal Health Issues (Point range: 6 - 68; where higher scores correspond to more severe menopausal health issues)'}, {'measure': 'Change in Sleep Disturbance', 'timeFrame': '6 weeks', 'description': 'Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)'}, {'measure': 'Change in Fatigue', 'timeFrame': '6 weeks', 'description': 'Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)'}, {'measure': 'Minimal clinically important difference (MCID) in perceived stress', 'timeFrame': '7 weeks', 'description': 'Likelihood of experiencing minimal clinically important difference in perceived stress, as assessed by NIH Toolbox Perceived Stress Survey (scale 10-50; where the higher scores correspond to worse perceived stress)'}, {'measure': 'Minimal clinically important difference (MCID) in menopausal health issues', 'timeFrame': '7 weeks', 'description': 'Likelihood of experiencing minimal clinically important difference in menopausal health issues score assessed by Radicle General Menopausal Health Issues (Point range: 6 - 68; where higher scores correspond to more severe menopausal health issues)'}, {'measure': 'Minimal clinically important difference (MCID) in fatigue', 'timeFrame': '7 weeks', 'description': 'Likelihood of experiencing minimal clinically important difference in fatigue score as assessed by PROMIS Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)'}, {'measure': 'Minimal clinically important difference (MCID) in sleep', 'timeFrame': '7 weeks', 'description': 'Likelihood of experiencing minimal clinically important difference in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress', 'Menopause', 'Fatigue', 'Sleep']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.radiclescience.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-Blind, Placebo-Controlled, Direct-to-Consumer Trial Assessing the Impact of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women with Peri-Menopausal Health Issues', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.\n\nEligible participants (1) are females, (2) have peri-menopausal-related health issues for 3 months or longer, (3) have the opportunity to improve by at least 30% in the primary outcome, and (4) express acceptance in taking study products and not knowing the formulation identities until the end of the study.\n\nParticipants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and ag who are pregnant or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.\n\nSelf-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities\n* Assigned sex at birth is female\n* Resides in the United States\n* Identifies menstrual status as perimenopausal\n* Has the opportunity for at least 30% improvement in their primary health outcome\n* Indicates having peri-menopausal issues for 3 months or longer\n* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study\n\nExclusion Criteria:\n\n* Individuals who report any of the following during screening will be excluded from participation:\n* Reports being pregnant or breastfeeding\n* Unable to provide a valid US shipping address and mobile phone number\n* Reports current enrollment in another clinical trial\n* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)\n* Unable to read and understand English\n* Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.\n* Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.\n* NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure\n* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.\n* Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products\n* Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk to participants\n* Reports an allergy to and/or disinterest in any of the possible study product ingredients\n* Lack of reliable daily access to the internet'}, 'identificationModule': {'nctId': 'NCT07117994', 'briefTitle': 'Radicle Revive 24: A Study of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Peri-Menopausal Health Issues', 'organization': {'class': 'INDUSTRY', 'fullName': 'Radicle Science'}, 'officialTitle': 'Radicle Revive™ 24_VPH: A Randomized, Double-Blind, Placebo-Controlled, Direct-to-Consumer Trial Assessing the Impact of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Peri-Menopausal Health Issues', 'orgStudyIdInfo': {'id': 'RADX_P_2414_VPH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control 1', 'description': 'Radicle Revive Placebo Control Form 1', 'interventionNames': ['Dietary Supplement: Radicle Revive Placebo Control Form 1']}, {'type': 'EXPERIMENTAL', 'label': 'Active Product 1', 'description': 'Radicle Revive Active Study Product 1', 'interventionNames': ['Dietary Supplement: Radicle Revive Active Study Product 1']}], 'interventions': [{'name': 'Radicle Revive Placebo Control Form 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.', 'armGroupLabels': ['Placebo Control 1']}, {'name': 'Radicle Revive Active Study Product 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will use their Radicle Revive Active Study Product 1 as directed for a period of 6 weeks.', 'armGroupLabels': ['Active Product 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92014-2605', 'city': 'Del Mar', 'state': 'California', 'country': 'United States', 'facility': 'Radicle Science, Inc', 'geoPoint': {'lat': 32.95949, 'lon': -117.26531}}], 'overallOfficials': [{'name': 'Susan Hewlings', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radicle Science Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared with researchers outside of Radicle Collaborators on this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radicle Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}