Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-02-27 @ 11:19 AM
Study NCT ID:
NCT02086032
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2014-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Different Types of Progestin on Sleeping of Menopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004967', 'term': 'Estrogens'}, {'id': 'D004394', 'term': 'Dydrogesterone'}, {'id': 'D011374', 'term': 'Progesterone'}, {'id': 'C000624167', 'term': 'Utrogestan'}], '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': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-28', 'studyFirstSubmitDate': '2014-03-01', 'studyFirstSubmitQcDate': '2014-03-12', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improving of sleeping quality (assessed by the PSQI score)', 'timeFrame': 'from March 2014 up to 15 months'}], 'secondaryOutcomes': [{'measure': 'The side effects comparing the 2 arms.', 'timeFrame': 'from March 2014 up to 15 months', 'description': 'Acne,melanoma, breast tenderness, abnormal vaginal bleeding, weight change'}, {'measure': 'The climacteric symptoms comparing the 2 arms.', 'timeFrame': 'from March 2014 up to 15 months', 'description': 'self reported of hot flash, fatigue and weakness'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sleeping quality', 'menopause', 'climacteric', 'progestin', 'dydrogesterone', 'micronized progesterone'], 'conditions': ['Menopausal and Postmenopausal Disorders']}, 'referencesModule': {'references': [{'pmid': '28609128', 'type': 'DERIVED', 'citation': 'Leeangkoonsathian E, Pantasri T, Chaovisitseree S, Morakot N. The effect of different progestogens on sleep in postmenopausal women: a randomized trial. Gynecol Endocrinol. 2017 Dec;33(12):933-936. doi: 10.1080/09513590.2017.1333094. Epub 2017 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'Investigators have found that sleeping disorder is an important problem in menopausal women.\n\nThere have been papers reporting the effect of hormonal therapy on sleeping, but fews have reported the effect of different progestogens on sleeping quality. There is a need for more in-depth study and more conclusive evidence about the progestins which have the most beneficial effects on sleeping disorders in menopausal women.\n\nThis study is going to collect the data from newly identified menopausal patients who are eligible for continuous estrogen-progestogen therapy for their climacteric treatment. The affects of the therapy will be monitored for 3 months.', 'detailedDescription': 'New patients who are eligible for hormonal therapy will be selected.\n\nThey will be allocated randomly into 2 different groups, each group being prescribed 1 of 2 regimens of hormonal therapy:\n\n* 17 beta estradiol 1mg/day plus oral micronized progesterone 100mg/day\n* 17 beta estradiol 1mg/day plus dydrogesterone 10mg/day Patients will have their sleeping quality accessed using the Pittsburgh sleep quality index(PSQI) at their 1st visit and once a month for 3 months. The first and third PSQI score will be analysed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* new menopausal patients at Maharaj Nakorn Chiang Mai Hospital\n* suitable for estrogen plus progesterone treatment\n\nExclusion Criteria:\n\n* contraindication for hormone replacement therapy\n* recently used sleep enhancing medicine\n* recently used psychotic medicine'}, 'identificationModule': {'nctId': 'NCT02086032', 'briefTitle': 'The Effect of Different Types of Progestin on Sleeping of Menopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'The Effect of Different Types of Progestin on Sleeping of Menopausal Women', 'orgStudyIdInfo': {'id': 'OBG-2556-02070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'micronized progesterone', 'description': '1 mg 17 beta-estradiol plus 100 mg micronized progesterone taken orally once a day for 3 months.', 'interventionNames': ['Drug: 1mg 17 beta-estradiol', 'Drug: micronized progesterone']}, {'type': 'EXPERIMENTAL', 'label': 'dydrogesterone', 'description': '1mg 17 beta-estradiol plus 10 mg dydrogesterone taken orally once a day for 3 months.', 'interventionNames': ['Drug: 1mg 17 beta-estradiol', 'Drug: Dydrogesterone']}], 'interventions': [{'name': '1mg 17 beta-estradiol', 'type': 'DRUG', 'otherNames': ['Estrogen'], 'description': 'Comparing sleeping quality between micronized progesterone and dydrogesterone users.', 'armGroupLabels': ['dydrogesterone', 'micronized progesterone']}, {'name': 'Dydrogesterone', 'type': 'DRUG', 'otherNames': ['Duphaston'], 'description': 'Comparing sleeping quality between micronised progesterone and dydrogesterone users.', 'armGroupLabels': ['dydrogesterone']}, {'name': 'micronized progesterone', 'type': 'DRUG', 'otherNames': ['Utrogestan'], 'description': 'Comparing sleeping quality between micronised progesterone and dydrogesterone users', 'armGroupLabels': ['micronized progesterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Muang', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Obstetrics and Gynecology department, Faculty of Medicine, Chiang Mai University'}], 'overallOfficials': [{'name': 'Tawiwan Pantasri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Chiang Mai University, Thailand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ekachai Leeangkoonsathian', 'investigatorAffiliation': 'Chiang Mai University'}}}}