Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-05 @ 6:27 PM
Study NCT ID:
NCT00184795
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D000077563', 'term': 'Norethindrone Acetate'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009640', 'term': 'Norethindrone'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 576}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2005-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-15', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean number of moderate to severe hot flushes per week', 'timeFrame': 'At week 8'}], 'secondaryOutcomes': [{'measure': 'Urogenital symptoms', 'timeFrame': 'Week 0; week 24'}, {'measure': 'Vaginal cytology and pH', 'timeFrame': 'Week 0; week 24'}, {'measure': 'Bleeding profile', 'timeFrame': 'Week 0; week 24'}, {'measure': 'Adverse Events', 'timeFrame': 'Week 0; week 24'}, {'measure': 'Menopausal symptoms and quality of life (Greene Climacteric Scale)', 'timeFrame': 'Week 0; week 24'}, {'measure': 'Hot flush weekly weighted score', 'timeFrame': 'Week 0; week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hot flashes'], 'conditions': ['Menopause', 'Menopausal Vasomotor Symptoms']}, 'referencesModule': {'references': [{'pmid': '18202966', 'type': 'RESULT', 'citation': 'Sturdee DW, Archer DF, Rakov V, Lang E; CHOICE Study Investigators. Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women. Climacteric. 2008 Feb;11(1):63-73. doi: 10.1080/13697130701852390.'}, {'pmid': '17487652', 'type': 'RESULT', 'citation': 'Lundstrom E, Bygdeson M, Svane G, Azavedo E, von Schoultz B. Neutral effect of ultra-low-dose continuous combined estradiol and norethisterone acetate on mammographic breast density. Climacteric. 2007 Jun;10(3):249-56. doi: 10.1080/13697130701385805.'}, {'pmid': '17453860', 'type': 'RESULT', 'citation': 'Panay N, Ylikorkala O, Archer DF, Gut R, Lang E. Ultra-low-dose estradiol and norethisterone acetate: effective menopausal symptom relief. Climacteric. 2007 Apr;10(2):120-31. doi: 10.1080/13697130701298107.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone replacement therapy) on frequency and severity of menopausal symptoms, bleeding patterns and safety of different hormonal combinations will be evaluated and compared to placebo over the six month treatment period.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal status\n* Subject should have had a minimum of 7 moderate to severe hot flushes per day, or a minimum of 50 moderate to severe hot flushes per week, during the last 2 weeks of the run-in (screening) period.\n* Subject with an intact uterus\n\nExclusion Criteria:\n\n* In accordance with existing labelling for estrogen/progestogen combinations\n* Body Mass Index (BMI) \\> 35.0 kg/m2\n* Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)\n* Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to influence estrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepin'}, 'identificationModule': {'nctId': 'NCT00184795', 'acronym': 'CHOICE', 'briefTitle': 'Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Six Month Double-blind, Randomised, Parallel-group, Placebo-controlled, Multi-centre Trial to Investigate the Efficacy and Safety of Two Ultra-low Dose Combinations With 0.5 mg Estradiol and 0.1 mg or 0.25 mg Norethisterone Acetate (Activelle Low Dose 0.1/Activelle Low Dose 0.25) for Treatment of Menopausal Symptoms', 'orgStudyIdInfo': {'id': 'ALD-1537'}, 'secondaryIdInfos': [{'id': '2004-000103-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALD 0.1', 'interventionNames': ['Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)']}, {'type': 'EXPERIMENTAL', 'label': 'ALD 0.25', 'interventionNames': ['Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': '0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)', 'type': 'DRUG', 'description': 'One tablet per day for 24 weeks', 'armGroupLabels': ['ALD 0.1']}, {'name': '0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)', 'type': 'DRUG', 'description': 'One tablet per day for 24 weeks', 'armGroupLabels': ['ALD 0.25']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo tablets for 24 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A 1060', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': 'A 1090', 'city': 'Vienna', 'country': 'Austria', 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