Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-28 @ 12:02 AM
Study NCT ID:
NCT00465192
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2007-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004958', 'term': 'Estradiol'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '1995-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2007-04-23', 'studyFirstSubmitQcDate': '2007-04-23', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1995-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relief of vaginal symptoms', 'timeFrame': 'following 12 weeks of treatment.'}], 'secondaryOutcomes': [{'measure': 'Adverse events'}, {'measure': 'Hematology and chemisty tests, and endometrial biopsy'}, {'measure': 'Vaginal and urethral cytology, and grading of vaginal health'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Menopause', 'Postmenopausal Vaginal Atrophy']}, 'referencesModule': {'references': [{'pmid': '18165394', 'type': 'DERIVED', 'citation': 'Bachmann G, Lobo RA, Gut R, Nachtigall L, Notelovitz M. Efficacy of low-dose estradiol vaginal tablets in the treatment of atrophic vaginitis: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):67-76. doi: 10.1097/01.AOG.0000296714.12226.0f.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy\n* Postmenopausal\n* Hysterectomized or non-hysterectomized\n* Moderate or severe vaginal dryness and soreness\n\nExclusion Criteria:\n\n* Known, suspected, or past history of breast cancer\n* Known, suspected, or past history of hormone-dependent tumor\n* Genital bleeding of unknown etiology\n* Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use\n* Vaginal infection\n* Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study\n* Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study\n* History of treatment with diethylstilbestrol'}, 'identificationModule': {'nctId': 'NCT00465192', 'briefTitle': 'Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis', 'orgStudyIdInfo': {'id': 'VAG/PD/009/USA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'estradiol, 10 mcg', 'type': 'DRUG'}, {'name': 'estradiol, 25 mcg', 'type': 'DRUG'}, {'name': 'placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}