Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-31 @ 10:25 AM
Study NCT ID:
NCT00369434
Status:
COMPLETED
Last Update Posted:
2007-06-01
First Post:
2006-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-31', 'studyFirstSubmitDate': '2006-08-25', 'studyFirstSubmitQcDate': '2006-08-25', 'lastUpdatePostDateStruct': {'date': '2007-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number and severity of hot flushes collected throughout the study after 12 weeks of therapy.'}], 'secondaryOutcomes': [{'measure': 'The number of awakenings due to VMS and the total mood disturbance score (Profile of Mood States [POMS]).'}, {'measure': 'The scores on the Greene Climacteric Scale (GCS), the Visual Analog Scale-Pain Intensity (VAS-PI), and the Satisfaction Survey (SS).'}]}, 'conditionsModule': {'conditions': ['Menopause', 'Vasomotor System']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of 100 mg and 150 mg of DVS SR, an extended release form of desvenlafaxine succinate, in comparison to placebo for the treatment of Vasomotor Symptoms (VMS) associated with menopause in a population of postmenopausal women.', 'detailedDescription': 'To assess the efficacy and safety of 100 mg and 150 mg of DVS SR in comparison to placebo for the treatment of moderate to severe VMS associated with menopause, as well as additional outcome indicators such as sleep disruptions, overall climacteric symptoms, mood changes, somatic symptoms, and overall satisfaction with DVS SR in postmenopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy, postmenopausal women who seek treatment for hot flushes\n* Body Mass Index (BMI) less than or equal to 40 kg/m2\n\nOther inclusions apply.\n\nExclusion Criteria:\n\n* Hypersensitivity to Venlafaxine\n* Myocardial infarction and/or unstable angina within 6 months of screening\n* History of seizure disorder\n\nOther exclusions apply.'}, 'identificationModule': {'nctId': 'NCT00369434', 'briefTitle': 'Study of the Safety and Efficacy of Desvenlafaxine Succinate for Vasomotor Symptoms in Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled, Efficacy and Safety Study of DVS SR for Treatment of Vasomotor Symptoms Associated With Menopause', 'orgStudyIdInfo': {'id': '3151A2-337'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Desvenlafaxine succinate sustained-release (DVS SR)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36106', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '80910', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '34613', 'city': 'Brooksville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'zip': '34452', 'city': 'Inverness', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.83582, 'lon': -82.33037}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 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'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58501', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45267-0457', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '16502', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15090', 'city': 'Wexford', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.62646, 'lon': -80.05589}}, {'zip': '29926', 'city': 'Hilton Head Island', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.19382, 'lon': -80.73816}}, {'zip': '84047', 'city': 'Midvale', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.61106, 'lon': -111.89994}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}