Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-08 @ 11:57 PM
Study NCT ID:
NCT02497560
Status:
TERMINATED
Last Update Posted:
2016-08-04
First Post:
2015-07-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Role of calcium in menopause is not clear. Product maybe reformulated and the study relaunched.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2015-07-06', 'studyFirstSubmitQcDate': '2015-07-10', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hot flashes episodes', 'timeFrame': '12 weeks', 'description': 'Diary'}], 'secondaryOutcomes': [{'measure': 'Work productivity', 'timeFrame': '12 weeks', 'description': 'Questionnaire'}, {'measure': 'Quality of Life', 'timeFrame': '12 weeks', 'description': 'Questionnaire'}]}, 'conditionsModule': {'conditions': ['Menopause']}, 'descriptionModule': {'briefSummary': 'This is a randomized, masked, placebo controlled study to assess the effect on a nutritional dietary supplement on menopausal signs and symptoms in perimenopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age group between 45 and 65 at the time of informed consent.\n* Physician diagnosis of menopause.\n* History of substantial hot flashes \\> 4 episodes /day for last 2 weeks.\n* Being post-menopausal with an intact uterus.\n* Subject has provided signed and dated written informed consent before admission to the study.\n\nExclusion Criteria:\n\n* Concurrent hot flash therapies (prescription medications including hormone replacement therapies, gabapentin or over the counter supplements), vaginal hormonal products (rings, creams, gels) or transdermal estrogen or estrogen/progestin products for 30 days before screening visit.\n* Women currently or previously on anticoagulants, Vitamin K antagonists like warfarin in the past 3 months, or expected to be on anticoagulants in the near future.\n* Women involved in other clinical studies within the last 30 days.\n* Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.'}, 'identificationModule': {'nctId': 'NCT02497560', 'briefTitle': 'A Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Physician Recommended Nutriceuticals'}, 'officialTitle': 'A Randomized Double Blind Placebo-Controlled Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms', 'orgStudyIdInfo': {'id': 'PRN 20144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'description': 'all natural dietary supplement', 'interventionNames': ['Dietary Supplement: proprietary formula']}, {'type': 'OTHER', 'label': 'Treatment + Omega-3s', 'description': 'all natural dietary supplement + omega-3s', 'interventionNames': ['Dietary Supplement: proprietary formula']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'vegetable oil', 'interventionNames': ['Dietary Supplement: proprietary formula']}], 'interventions': [{'name': 'proprietary formula', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo', 'Treatment', 'Treatment + Omega-3s']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80910', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': "Comprehensive Women's Care", 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '19148', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Dittrich Clinic', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Physician Recommended Nutriceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}