Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-27 @ 2:42 AM
Study NCT ID:
NCT01105793
Status:
COMPLETED
Last Update Posted:
2011-10-26
First Post:
2010-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005348', 'term': 'Fibrocystic Breast Disease'}], 'ancestors': [{'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003613', 'term': 'Danazol'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-25', 'studyFirstSubmitDate': '2010-04-13', 'studyFirstSubmitQcDate': '2010-04-15', 'lastUpdatePostDateStruct': {'date': '2011-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in breast pain', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cyclic mastalgia', 'cyclic breast pain', 'fibrocystic breast disease'], 'conditions': ['Moderate to Severe Cyclic Mastalgia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety of topical FP1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of FP1198.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* menstruating females at least 18 years of age\n* BMI less than 30\n* moderate to severe breast pain associated with the menstrual cycle\n* in good general health\n\nExclusion Criteria:\n\n* pregnant within the last 6 months\n* has taken in the last 3 months or currently taking hormonal contraception\n* history of malignancy or currently being treated for cancer of the breast or genital organs\n* has had breast implants or breast reduction surgery'}, 'identificationModule': {'nctId': 'NCT01105793', 'briefTitle': 'An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia', 'organization': {'class': 'INDUSTRY', 'fullName': 'FemmePharma Global Healthcare, Inc.'}, 'orgStudyIdInfo': {'id': 'FP1198-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Danazol', 'type': 'DRUG', 'description': 'High dose FP1198 applied once daily to both breasts for 6 treatment cycles.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Women's Health Care", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Horizons Clinical Research', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Medical Research Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Salt Lake Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FemmePharma Global Healthcare, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}