Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-03-09 @ 7:17 AM
Study NCT ID:
NCT00238732
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2005-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C447119', 'term': 'bazedoxifene'}, {'id': 'D004966', 'term': 'Estrogens, Conjugated (USP)'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 650}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-19', 'studyFirstSubmitDate': '2005-10-12', 'studyFirstSubmitQcDate': '2005-10-12', 'lastUpdatePostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.'}, {'measure': 'Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.'}], 'secondaryOutcomes': [{'measure': 'Vaginal pH at screening, and weeks 4 and 12.'}, {'measure': 'Most bothersome moderate or severe vulvar/vaginal atrophy sympton at screening, and weeks 4 and 12.'}]}, 'conditionsModule': {'keywords': ['Vaginal Atrophy', 'Postmenopause'], 'conditions': ['Vaginal Atrophy']}, 'referencesModule': {'references': [{'pmid': '37619252', 'type': 'DERIVED', 'citation': 'Lara LA, Cartagena-Ramos D, Figueiredo JB, Rosa-E-Silva ACJ, Ferriani RA, Martins WP, Fuentealba-Torres M. Hormone therapy for sexual function in perimenopausal and postmenopausal women. Cochrane Database Syst Rev. 2023 Aug 24;8(8):CD009672. doi: 10.1002/14651858.CD009672.pub3.'}, {'pmid': '28539177', 'type': 'DERIVED', 'citation': 'Pinkerton JV, Bushmakin AG, Komm BS, Abraham L. Relationship between changes in vulvar-vaginal atrophy and changes in sexual functioning. Maturitas. 2017 Jun;100:57-63. doi: 10.1016/j.maturitas.2017.03.315. Epub 2017 Mar 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy, postmenopausal women, aged 40 to 65 years\n* Intact uterus\n* At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome\n\nExclusion Criteria:\n\n* Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia\n* Thrombophlebitis, thrombosis or thromboembolic disorders\n* Neuro-ocular disease'}, 'identificationModule': {'nctId': 'NCT00238732', 'briefTitle': 'Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause', 'organization': {'class': 'INDUSTRY', 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