Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT00601367
Status:
COMPLETED
Last Update Posted:
2014-06-20
First Post:
2008-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland', 'Norway']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kbarbour@sproutpharma.com', 'phone': '9198820850', 'title': 'Krista Barbour, Ph.D.', 'organization': 'Sprout Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Flibanserin Flexible Dose', 'description': 'Initial dosage:\n\nPatients were to take one 50 mg flibanserin tablet in the evening.\n\nSubsequent dosage titrations:\n\nFlibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.', 'otherNumAtRisk': 480, 'otherNumAffected': 275, 'seriousNumAtRisk': 480, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 78, 'numAffected': 69}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 71, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 54, 'numAffected': 47}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 47, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 52, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 29, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast Cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine with aura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exomphalos', 'stats': [{'groupId': 'EG000', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Flibanserin Flexible Dose', 'description': 'Initial dosage:\n\nPatients were to take one 50 mg flibanserin tablet in the evening.\n\nSubsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.'}], 'classes': [{'title': 'patients with any adverse event', 'categories': [{'measurements': [{'value': '331', 'groupId': 'OG000'}]}]}, {'title': 'patients with drug-related adverse events', 'categories': [{'measurements': [{'value': '206', 'groupId': 'OG000'}]}]}, {'title': 'patients with adverse events leading to discontinu', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': 'patients with severe adverse events', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'patients with serious adverse events', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 weeks', 'unitOfMeasure': 'participants with any adverse event', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flibanserin Flexible Dose', 'description': 'Initial dosage:\n\nPatients were to take one 50 mg flibanserin tablet in the evening.\n\nSubsequent dosage titrations:\n\nFlibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '480'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '293'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Flibanserin Flexible Dose', 'description': 'Initial dosage:\n\nPatients were to take one 50 mg flibanserin tablet in the evening.\n\nSubsequent dosage titrations:\n\nFlibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.\n\nFlibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site.\n\nflibanserin flexible dose: Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening.\n\nSubsequent dosage titrations:\n\nFlibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the pati'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-29 years', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '211', 'groupId': 'BG000'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '170', 'groupId': 'BG000'}]}]}, {'title': '50 years and older', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '480', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '442', 'groupId': 'BG000'}]}]}, {'title': 'White Hispanic', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 480}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-20', 'studyFirstSubmitDate': '2008-01-15', 'resultsFirstSubmitDate': '2014-04-22', 'studyFirstSubmitQcDate': '2008-01-25', 'lastUpdatePostDateStruct': {'date': '2014-06-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-20', 'studyFirstPostDateStruct': {'date': '2008-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Adverse Events', 'timeFrame': '28 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sexual Dysfunctions, Psychological']}, 'descriptionModule': {'briefSummary': 'Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women with a primary diagnosis of HSDD who still needs to be treated according to the investigator's opinion and willing to continue in this study. This continuation requires adequate compliance, in the Investigators judgement, with trial medication and the trial visit required in the parent clinical trial (Visit 1 to visit 9).\n* Patients must have used a medically acceptable method of contraception \\[i.e., double barrier method (e.g., diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable, intra-vaginal, or oral contraceptive), intrauterine device, tubal sterilization, or partner's surgical sterilization\\] for at least 3 months before the Screen Visit and continue to use that medically acceptable method of contraception during the trial.\n\nExclusion Criteria:\n\n* Patients with a history of MDD within 6 months prior the Screen Visit or a score of 14 on the Beck Depression Inventory II, or a history of suicide attempt according to the Beck Scale for Suicide Ideation, or patient with any non-zero statement in the first five items for the Beck Scale for Suicide Ideation.\n* Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Inclusion Visit.\n* Patients with findings at the Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.\n* Patients experiencing major life stress (including parenting pressure, eldercare, loss of income, death of a family member, etc.) or relationship discord that could interfere with sexual activity, except distress about HSDD.\n* Clinically significant ECG abnormalities at the Screen Visit, according to the investigators opinion or the cardiologist who have performed the ECG. The following ECG values are considered to be exclusionary: QTc intervals \\>480 milliseconds (ms), PR intervals \\>240 ms, and QRS intervals \\>110 ms."}, 'identificationModule': {'nctId': 'NCT00601367', 'briefTitle': 'Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sprout Pharmaceuticals, Inc'}, 'officialTitle': 'A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD', 'orgStudyIdInfo': {'id': '511.118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'flibanserin flexible dose', 'description': 'Initial dosage:\n\nPatients were to take one 50 mg flibanserin tablet in the evening.\n\nSubsequent dosage titrations:\n\nFlibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.\n\nFlibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY.\n\nFlibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.', 'interventionNames': ['Drug: flibanserin flexible dose']}], 'interventions': [{'name': 'flibanserin flexible dose', 'type': 'DRUG', 'description': 'Initial dosage:\n\nPatients were to take one 50 mg flibanserin tablet in the evening.\n\nSubsequent dosage titrations:\n\nFlibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.\n\nFlibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY.\n\nFlibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.', 'armGroupLabels': ['flibanserin flexible dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Innsbruck', 'country': 'Austria', 'facility': '511.118.43005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Vienna', 'country': 'Austria', 'facility': '511.118.43002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Vienna', 'country': 'Austria', 'facility': '511.118.43004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Wörgl', 'country': 'Austria', 'facility': '511.118.43006 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.48906, 'lon': 12.06174}}, {'city': "Braine-l'Alleud", 'country': 'Belgium', 'facility': '511.118.32004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.68363, 'lon': 4.36784}}, {'city': 'Edegem', 'country': 'Belgium', 'facility': '511.118.32003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': '511.118.32005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': '511.118.32006 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Yvoir', 'country': 'Belgium', 'facility': '511.118.32002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'city': 'Olomouc', 'country': 'Czechia', 'facility': '511.118.42001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 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'country': 'Germany', 'facility': '511.118.49004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'facility': '511.118.49001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Dresden', 'country': 'Germany', 'facility': '511.118.49006 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': '511.118.49008 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': '511.118.49003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Hanover', 'country': 'Germany', 'facility': '511.118.49002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': '511.118.49005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': '511.118.36001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Kecskemét', 'country': 'Hungary', 'facility': '511.118.36005 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 46.90618, 'lon': 19.69128}}, {'city': 'Szeged', 'country': 'Hungary', 'facility': '511.118.36003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Szentes', 'country': 'Hungary', 'facility': '511.118.36004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 46.65834, 'lon': 20.2608}}, {'city': 'Catania', 'country': 'Italy', 'facility': '511.118.39004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Pavia', 'country': 'Italy', 'facility': 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