Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT01724658
Status:
COMPLETED
Last Update Posted:
2014-01-29
First Post:
2012-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2014-05-19', 'unreleaseDateUnknown': True}, {'resetDate': '2015-02-06', 'releaseDate': '2015-01-23'}], 'estimatedResultsFirstSubmitDate': '2014-05-19'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C010792', 'term': 'testosterone undecanoate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-28', 'studyFirstSubmitDate': '2012-10-12', 'studyFirstSubmitQcDate': '2012-11-07', 'lastUpdatePostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'female sexual function index score', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'adverse effects of the drug', 'timeFrame': '8 week', 'description': '1. weight gain\n2. acne\n3. hirsutism.\n4. vaginal bleeding'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['female sexual function', 'postmenopause', 'testosterone'], 'conditions': ['Female Sexual Dysfunction']}, 'referencesModule': {'references': [{'pmid': '12626215', 'type': 'RESULT', 'citation': 'Floter A, Nathorst-Boos J, Carlstrom K, von Schoultz B. Addition of testosterone to estrogen replacement therapy in oophorectomized women: effects on sexuality and well-being. Climacteric. 2002 Dec;5(4):357-65.'}, {'pmid': '26631095', 'type': 'DERIVED', 'citation': 'Tungmunsakulchai R, Chaikittisilpa S, Snabboon T, Panyakhamlerd K, Jaisamrarn U, Taechakraichana N. Effectiveness of a low dose testosterone undecanoate to improve sexual function in postmenopausal women. BMC Womens Health. 2015 Dec 2;15:113. doi: 10.1186/s12905-015-0270-6.'}]}, 'descriptionModule': {'briefSummary': 'Additional testosterone undecanoate can improve female sexual function in postmenopausal women which one aspects of quality of life. The dose adjustment can reduce incidence of adverse effects and low cost of treatment with effective outcome.', 'detailedDescription': 'Research Question:\n\n" Does oral testosterone undecanoate improve sexual problem in postmenopausal women? " Type Research:Clinical research\n\nStudy design:\n\nRandomized double-blinded placebo controlled trial'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* postmenopausal women with age between 40-60 years\n* Women complain about her sexual problem and her score of Female Sexual Function Index ≤ 26.5\n\nExclusion Criteria:\n\n* women with previous use of hormonal replacement or anti-psychiatric drugs within 3 months\n* women with history of or present premalignancies/malignancies\n* women present with liver disease or abnormal liver enzyme\n* women with active cardiovascular, cerebrovascular or thromboembolic disorders\n* women with Present psychiatric disease\n* Partner have sexual dysfunction'}, 'identificationModule': {'nctId': 'NCT01724658', 'briefTitle': 'Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Effectiveness of Testosterone Undecanoate to Improve Sexual Function in Postmenopausal Women', 'orgStudyIdInfo': {'id': 'CU0115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Testosterone undecanoate', 'description': 'testosterone undecanoate 40 mg orally twice a week plus progynova 1mg oral daily', 'interventionNames': ['Drug: Testosterone undecanoate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo twice a week with progynova 1 mg oral daily', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Testosterone undecanoate', 'type': 'DRUG', 'otherNames': ['Andriol'], 'description': 'testosterone undecanoate 40 mg orally twice a week', 'armGroupLabels': ['Testosterone undecanoate']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo orally twice a week with progynova 1 mg oral daily', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'state': 'Bankok', 'country': 'Thailand', 'facility': 'King Chulalongkorn memorial hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Reuthairat Tungmunsakulchai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Menopause unit of Chulalongkorn hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-05-19', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2015-01-23', 'type': 'RELEASE'}, {'date': '2015-02-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Chulalongkorn University'}}}}