Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 5:11 AM
Study NCT ID:
NCT01647360
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
2012-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008595', 'term': 'Menorrhagia'}, {'id': 'D008796', 'term': 'Metrorrhagia'}], 'ancestors': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-27', 'studyFirstSubmitDate': '2012-07-19', 'studyFirstSubmitQcDate': '2012-07-20', 'lastUpdatePostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EQ-5D Quality of Life questionnaire', 'timeFrame': '3 months', 'description': 'The EQ-5D assesses five dimensions of HRQOL: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension is measured on a three-point ordinal scale where a higher score corresponds to a worse health state (no limitation, some limitation, and greatest limitation in HRQOL). This will be evaluated at baseline and then at each follow up visit to see impact on quality of life.'}], 'secondaryOutcomes': [{'measure': 'Pictorial Blood Assessment Chart (PBAC) score', 'timeFrame': '3 months', 'description': 'PBAC score of 100 or more corresponds with heavy menstrual bleeding. PBAC score will be assessed at each visit to see any improvement.'}, {'measure': 'Menstrual Cycle Diary', 'timeFrame': '3 months', 'description': "Change in the nature of menstruation will be taken into account based on the subjects' perception as recorded on the Menstrual Cycle Diary."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metrorrhagia', 'Menorrhagia'], 'conditions': ['Menorrhagia', 'Metrorrhagia']}, 'descriptionModule': {'briefSummary': 'Dydrogesterone is a retroprogesterone with a molecular structure similar to natural progesterone. As a C-21 steroid, it has a high affinity for progesterone receptors, a low antigonadotropic activity and antiestrogenic activity, but almost no estrogenic or androgenic activity. Dydrogesterone (Duphaston©) is indicated for dysfunctional bleeding.\n\nIn this study, women suffering from menorrhagia and who are treated with dydrogesterone will be observed for impact on QoL with the reduction in severity of bleeding.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women with heavy menstrual bleeding', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Females aged 18 to 45 years\n* Subjects presenting with Heavy Menstrual Bleeding (HMB)\n* Subjects with Pictorial Blood Assessment Chart (PBAC) score of 100 or more\n* Subjects will be treated with dydrogesterone in accordance to the local label after enrollment in the trial\n\nExclusion Criteria\n\n* Subjects with structural or organic pathology as an underlying cause of HMB.\n* Subjects with hypersensitivity to dydrogesterone\n* Known or suspected progestogen dependent neoplasms\n* Subjects with vaginal bleeding who have not been screened for organic or structural pathology as an underlying cause\n* Subjects with acute or chronic liver disease\n* Patients with depressive illness\n* Subjects who are known to have rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption\n* Nursing mothers\n* Use of any other medication for uterine bleeding (including but not limited to progesterone, oral contraceptive pills, tranexamic acid etc)\n* Use of Non-Steroidal Anti inflammatory Drugs (NSAIDs)'}, 'identificationModule': {'nctId': 'NCT01647360', 'briefTitle': 'Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Post- Marketing, Prospective,Multicenter, Observational Program: Severity of Bleeding as a Predictor of Quality of Life (QoL) in Women With Heavy Menstrual Bleeding (HMB) Under Dydrogesterone Treatment', 'orgStudyIdInfo': {'id': 'P13-699'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with Heavy Menstrual Bleeding (HMB)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad, Federal Capital', 'country': 'Pakistan', 'facility': 'Site reference ID/Investigator# 79836', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'zip': '74000', 'city': 'Karachi, Sindh', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 77674', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '74000', 'city': 'Karachi, Sindh', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 77675', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '74000', 'city': 'Karachi, Sindh', 'country': 'Pakistan', 'facility': 'Site reference ID/Investigator# 77676', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '74000', 'city': 'Karachi, Sindh', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 77677', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '74000', 'city': 'Karachi, Sindh', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 77680', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '74000', 'city': 'Karachi, Sindh', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 77681', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '54000', 'city': 'Lahore, Punjab', 'country': 'Pakistan', 'facility': 'Site reference ID/Investigator # 77690', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54000', 'city': 'Lahore, Punjab', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 77691', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54000', 'city': 'Lahore, Punjab', 'country': 'Pakistan', 'facility': 'Site reference ID/Investigator# 77694', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54000', 'city': 'Lahore, Punjab', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 77695', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54000', 'city': 'Lahore, Punjab', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 77696', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54000', 'city': 'Lahore, Punjab', 'country': 'Pakistan', 'facility': 'Site reference ID/Investigator# 77698', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '54000', 'city': 'Lahore, Punjab', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 77699', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'zip': '60000', 'city': 'Multan, Punjab', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 77686', 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}, {'zip': '60000', 'city': 'Multan, Punjab', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 77687', 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}, {'zip': '6000', 'city': 'Multan, Punjab', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 77684', 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}, {'zip': '6000', 'city': 'Multan, Punjab', 'country': 'Pakistan', 'facility': 'Site Reference ID/Investigator# 77689', 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}, {'zip': '46000', 'city': 'Rawalpindi, Punjab', 'country': 'Pakistan', 'facility': 'Site reference ID/Investigator # 77693', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}, {'zip': '46000', 'city': 'Rawalpindi, Punjab', 'country': 'Pakistan', 'facility': 'Site reference ID/Investigator# 79834', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Raeef Ahmed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}