Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT03436303
Status:
UNKNOWN
Last Update Posted:
2018-02-19
First Post:
2018-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Benefits and Risks of Different Menopausal Hormone Replacement Therapy Regimes in the Treatment of Menopause Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C031278', 'term': '2-chloroethyl ethyl sulfide'}, {'id': 'D004394', 'term': 'Dydrogesterone'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomly assigned to three groups: CEE 0.3 mg/micronized progesterone (MP) 100 mg group, CEE 0.625 mg/MP 100 mg group,CEE 0.625 mg/dydrogesterone 10 mg group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-10', 'studyFirstSubmitDate': '2018-02-02', 'studyFirstSubmitQcDate': '2018-02-10', 'lastUpdatePostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LDL-cholesterol', 'timeFrame': '5 minutes'}, {'measure': 'body fat mass percentage', 'timeFrame': '5 minutes', 'description': 'DEXA method'}, {'measure': 'breast mammography', 'timeFrame': '5 minutes'}], 'secondaryOutcomes': [{'measure': 'glucose', 'timeFrame': '5 minutes'}, {'measure': 'bone mineral density', 'timeFrame': '5 minutes'}, {'measure': 'Mini-mental State Examination score', 'timeFrame': '5 minutes', 'description': 'Questionnaire.The score range is 0-30.Total score greater than or equal to 24 points indicates a normal cognition,below this, scores can indicate cognitive impairment.'}, {'measure': 'HAD scale', 'timeFrame': '5 minutes', 'description': 'questionnaire to evaluate anxiety and depression.The total score is 0-20.Total score 0-7 is normal,8-10 maybe borderline anxiety or depression,11-20 indicates obvious anxiety or depression.'}, {'measure': 'modified Kupperman score', 'timeFrame': '5 minutes', 'description': 'questionnaire to evaluate the menopause symptom.The total score range is 0-63.Total score below 6 is normal,6-15 is mild,16-30 is moderate, above 30 is severe'}, {'measure': 'Endometrial thickness', 'timeFrame': '5 minutes', 'description': 'ultrasound'}, {'measure': 'weight', 'timeFrame': '5 minutes'}, {'measure': 'serum creatinine', 'timeFrame': '5 minutes'}, {'measure': 'serum glutamic pyretic transaminase', 'timeFrame': '5 minutes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Menopause Syndrome', 'low dose estrogen', 'progestin'], 'conditions': ['Menopause Syndrome']}, 'referencesModule': {'references': [{'pmid': '17689624', 'type': 'BACKGROUND', 'citation': "Thorneycroft IH, Lindsay R, Pickar JH. Body composition during treatment with conjugated estrogens with and without medroxyprogesterone acetate: analysis of the women's Health, Osteoporosis, Progestin, Estrogen (HOPE) trial. Am J Obstet Gynecol. 2007 Aug;197(2):137.e1-7. doi: 10.1016/j.ajog.2007.05.042."}, {'pmid': '15252707', 'type': 'BACKGROUND', 'citation': "Margolis KL, Bonds DE, Rodabough RJ, Tinker L, Phillips LS, Allen C, Bassford T, Burke G, Torrens J, Howard BV; Women's Health Initiative Investigators. Effect of oestrogen plus progestin on the incidence of diabetes in postmenopausal women: results from the Women's Health Initiative Hormone Trial. Diabetologia. 2004 Jul;47(7):1175-1187. doi: 10.1007/s00125-004-1448-x. Epub 2004 Jul 14."}]}, 'descriptionModule': {'briefSummary': 'A prospective, open-label, randomized controlled clinical trial to compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(CEE) plus natural progesterone or dydrogesterone in menopausal hormone therapy .', 'detailedDescription': 'This is a prospective, open-label, randomized controlled clinical trial compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(CEE) plus natural progesterone or dydrogesterone in menopausal hormone therapy during window phase. 120 Healthy postmenopausal women with intact uterus seeking treatment for menopausal symptoms are enrolled in this study.Participants are randomized into three groups, the CEE 0.3 mg/micronized progesterone (MP) 100 mg group; CEE 0.625 mg/MP 100 mg group; CEE 0.625 mg/dydrogesterone 10 mg group,metabolic parameters,body composition,bone mineral density,breast cancer risk factors and life quality will be measure at baseline,one year and two year intervention.The investigators hypothesize there may be differences of these parameters measured among three groups after intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 40 and 60 years old;\n2. natural amenorrhea for more than 6 months but less than 5 years;\n3. suffered by menopause symptoms and seeking for treatment;\n4. serum follicle-stimulating hormone levels \\>40 IU/L and serum estradiol \\<30 pg/ml.\n\nExclusion Criteria:\n\n1. contraindications for menopausal hormone therapy;\n2. complications including: uterine myoma more than 3 centimeter in diameter, endometriosis, uncontrolled hypertension or diabetes mellitus, thromboembolic disease history or high risk for developing thromboembolic disease, epilepsy, asthma, hyperprolactinemia, first degree relative has breast cancer;\n3. cardiovascular, chronic liver, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol;\n4. alcohol or drug abuse within the last 3 months;\n5. use of hormone therapy in the past 3months;\n6. endometrial thickness more than 5mm even after progestin withdrawal;\n7. abnormal cervical scraping smear;\n8. allergic to any ingredient of the drugs;\n9. participation in other clinical trials within the last 6 months."}, 'identificationModule': {'nctId': 'NCT03436303', 'briefTitle': 'The Benefits and Risks of Different Menopausal Hormone Replacement Therapy Regimes in the Treatment of Menopause Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Effect and Risk of Conjugated Estrogens Combined With Different Types of Progestin in the Treatment of Menopause Syndrome During Window Phase', 'orgStudyIdInfo': {'id': 'HRT14021808'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CEE 0.625 mg/MP 100mg', 'description': 'CEE 0.625 mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years', 'interventionNames': ['Drug: CEE 0.625 mg/MP 100mg']}, {'type': 'EXPERIMENTAL', 'label': 'CEE 0.3 mg/MP 100mg', 'description': 'CEE 0.3mg/micronized progesterone (MP) 100 mg daily for the last 12 days of every 28 days for two years', 'interventionNames': ['Drug: CEE 0.3 mg/MP 100mg']}, {'type': 'EXPERIMENTAL', 'label': 'CEE 0.625 mg/dydrogesterone 10mg', 'description': 'CEE 0.625 mg/dydrogesterone 10 mg daily for the last 12 days of every 28 days for two years', 'interventionNames': ['Drug: CEE 0.625mg/dydrogesterone']}], 'interventions': [{'name': 'CEE 0.625 mg/MP 100mg', 'type': 'DRUG', 'description': 'CEE 0.625 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years', 'armGroupLabels': ['CEE 0.625 mg/MP 100mg']}, {'name': 'CEE 0.3 mg/MP 100mg', 'type': 'DRUG', 'description': 'CEE 0.3 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years', 'armGroupLabels': ['CEE 0.3 mg/MP 100mg']}, {'name': 'CEE 0.625mg/dydrogesterone', 'type': 'DRUG', 'description': 'CEE 0.3 mg/dydrogesterone 10mg daily for the last 12 days of every 28 days for two years', 'armGroupLabels': ['CEE 0.625 mg/dydrogesterone 10mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'China/Beiing', 'country': 'China', 'facility': 'Lei Li', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Aijun Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital,Peking Union Medical College, Chinese Academy of Medicine Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Within 2 months after the trial complete', 'ipdSharing': 'YES', 'description': 'Network platform, and the website will be attached later.', 'accessCriteria': 'Data access requests will be reviewed by an external independent review panel.Requestors will be required to sign a Data Access Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Aijun Sun', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}