Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT01358760
Status:
COMPLETED
Last Update Posted:
2017-06-12
First Post:
2011-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059268', 'term': 'Atrophic Vaginitis'}], 'ancestors': [{'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003687', 'term': 'Dehydroepiandrosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015068', 'term': '17-Ketosteroids'}, {'id': 'D007664', 'term': 'Ketosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'celine.martel@endoceutics.com', 'phone': '418-653-0033', 'title': 'Director of Data Analysis', 'phoneExt': '215', 'organization': 'Endoceutics'}, 'certainAgreement': {'otherDetails': 'Investigators shall provide to the SPONSOR 30 days prior to submission all documents for publication, presentation, etc that report any trial results. The SPONSOR shall have editorial rights on documents and the right to review/comment with regard to (1) proprietary information, (2) accuracy of the information, (3) correctness of the scientific evaluation/conclusions and (4) to ensure that the information is fairly balanced and in compliance with regulations.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline to Week 12 (+ 30-day follow-up period after last dose)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.', 'otherNumAtRisk': 150, 'otherNumAffected': 19, 'seriousNumAtRisk': 150, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '0.25% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.', 'otherNumAtRisk': 143, 'otherNumAffected': 17, 'seriousNumAtRisk': 143, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '0.50% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.', 'otherNumAtRisk': 148, 'otherNumAffected': 23, 'seriousNumAtRisk': 148, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 148, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 148, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Movement disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG001', 'title': '0.25% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG002', 'title': '0.50% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '60.66', 'spread': '3.40', 'groupId': 'OG000'}, {'value': '56.74', 'spread': '3.69', 'groupId': 'OG001'}, {'value': '59.54', 'spread': '3.41', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '62.22', 'spread': '3.49', 'groupId': 'OG000'}, {'value': '39.23', 'spread': '3.15', 'groupId': 'OG001'}, {'value': '33.02', 'spread': '3.09', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '1.56', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '-17.51', 'spread': '2.74', 'groupId': 'OG001'}, {'value': '-26.52', 'spread': '2.94', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.', 'unitOfMeasure': 'percentage of parabasal cells', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG001', 'title': '0.25% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG002', 'title': '0.50% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '0.93', 'spread': '0.11', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.80', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '3.43', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '3.58', 'spread': '0.41', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '2.66', 'spread': '0.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.', 'unitOfMeasure': 'percentage of superficial cells', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Vaginal pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG001', 'title': '0.25% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG002', 'title': '0.50% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.34', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '6.27', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '6.29', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '6.06', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '5.69', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '5.67', 'spread': '0.08', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.62', 'spread': '0.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.', 'unitOfMeasure': 'pH units', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG001', 'title': '0.25% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG002', 'title': '0.50% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.38', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '2.37', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '2.35', 'spread': '0.04', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.27', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '1.13', 'spread': '0.08', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-1.12', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-1.28', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-1.22', 'spread': '0.08', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.', 'unitOfMeasure': 'Severity score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Severity of Dyspareunia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG001', 'title': '0.25% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG002', 'title': '0.50% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.56', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '2.60', 'spread': '0.05', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.78', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '1.54', 'spread': '0.10', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-1.10', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-1.06', 'spread': '0.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.', 'unitOfMeasure': 'Severity score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses on dyspareunia were performed on a subgroup of the Intent to Treat (ITT) population (defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria) who had self-identified moderate to severe dyspareunia at Baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG001', 'title': '0.25% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG002', 'title': '0.50% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.71', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '2.55', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '2.55', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.33', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '2.07', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '2.07', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '0.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.', 'unitOfMeasure': 'Severity score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG001', 'title': '0.25% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG002', 'title': '0.50% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.32', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '2.19', 'spread': '0.08', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.94', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '1.74', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '1.69', 'spread': '0.07', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '0.08', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.', 'unitOfMeasure': 'Severity score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG001', 'title': '0.25% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG002', 'title': '0.50% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.78', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '2.72', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.40', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '2.25', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '2.16', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.56', 'spread': '0.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.', 'unitOfMeasure': 'Severity score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG001', 'title': '0.25% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'OG002', 'title': '0.50% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.66', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '2.60', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '2.65', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.31', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '2.16', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '2.12', 'spread': '0.06', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.53', 'spread': '0.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.', 'unitOfMeasure': 'Severity score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed primarily on the Intent to Treat (ITT) population defined as all subjects who have received at least one dose of study drug with a baseline (Day 1) evaluation meeting the study entry criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'FG001', 'title': '0.25% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'FG002', 'title': '0.50% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '148'}, {'groupId': 'FG002', 'numSubjects': '150'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '143'}, {'groupId': 'FG002', 'numSubjects': '148'}]}, {'type': 'ITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Entry criteria not met/Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '16'}]}]}], 'recruitmentDetails': 'A total of 897 subjects were screened at 42 medical/research sites located in the US (32 centers) and Canada (10 centers) and 450 subjects were randomized. The first subject first visit was on 21-JUN-2011 and the last subject last visit was on 12-APR-2012.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'BG001', 'title': '0.25% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'BG002', 'title': '0.50% DHEA', 'description': 'DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.59', 'spread': '6.47', 'groupId': 'BG000'}, {'value': '58.41', 'spread': '6.02', 'groupId': 'BG001'}, {'value': '58.33', 'spread': '6.16', 'groupId': 'BG002'}, {'value': '58.11', 'spread': '6.22', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White caucasian', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '398', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Analysis Population corresponds to the Safety Population which includes all subjects who received any amount of DHEA (prasterone) or placebo, and who have any safety information available.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'dispFirstSubmitDate': '2013-05-01', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-08', 'studyFirstSubmitDate': '2011-05-20', 'dispFirstSubmitQcDate': '2013-05-01', 'resultsFirstSubmitDate': '2017-03-17', 'studyFirstSubmitQcDate': '2011-05-23', 'dispFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-08', 'studyFirstPostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear', 'timeFrame': 'Baseline and Week 12', 'description': 'The percentage of parabasal cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.'}, {'measure': 'Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear', 'timeFrame': 'Baseline and Week 12', 'description': 'The percentage of superficial cells was determined from the vaginal smears collected during the study. A 100-cell count was performed by a central laboratory to classify cells as parabasal (P) (including basal), intermediate (I), and superficial (S) squamous cell types. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.'}, {'measure': 'Change From Baseline to Week 12 in Vaginal pH', 'timeFrame': 'Baseline and Week 12', 'description': 'A pH strip fixed on an Ayre spatula (or equivalent) was applied directly to the lateral wall of the vagina. The change in color of the pH indicator strip was compared to the color chart for pH evaluation. The corresponding pH value (with one decimal) was recorded. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.'}, {'measure': 'Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Vaginal Dryness', 'timeFrame': 'Baseline and Week 12', 'description': 'The severity of vaginal dryness was evaluated by a questionnaire filled out by women. The severity of dryness recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Severity of Dyspareunia', 'timeFrame': 'Baseline and Week 12', 'description': 'The severity of dyspareunia was evaluated by a questionnaire filled out by women. The severity of dyspareunia recorded as none, mild, moderate or severe was analyzed using the score values of 0, 1, 2 or 3, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.'}, {'measure': 'Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Secretions', 'timeFrame': 'Baseline and Week 12', 'description': 'To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal secretions (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy were analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.'}, {'measure': 'Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Integrity', 'timeFrame': 'Baseline and Week 12', 'description': 'To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial integrity (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.'}, {'measure': 'Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Epithelial Surface Thickness', 'timeFrame': 'Baseline and Week 12', 'description': 'To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal epithelial surface thickness (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.'}, {'measure': 'Change From Baseline to Week 12 in Severity of Vaginal Atrophy as Evaluated From Vaginal Color', 'timeFrame': 'Baseline and Week 12', 'description': 'To evaluate the aspect of the mucosa and the local tolerance to prasterone ovules, the vaginal color (one of the four main signs of vaginal atrophy) evaluated by the physician/gynecologist as corresponding to none, mild, moderate, or severe atrophy was analyzed using the score values of 1, 2, 3 and 4, respectively. Data obtained at Baseline and Week 12 as well as the change from Baseline to Week 12 are presented.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Vulvar/vaginal atrophy', 'Atrophic Vaginitis', 'Dehydroepiandrosterone', 'DHEA', 'Prasterone', 'Vaginorm', 'Menopause', 'Intrarosa'], 'conditions': ['Vaginal Atrophy']}, 'referencesModule': {'references': [{'pmid': '25511551', 'type': 'RESULT', 'citation': 'Bouchard C, Labrie F, Archer DF, Portman DJ, Koltun W, Elfassi E, Grainger DA, Ayotte N, Cooper TA, Martens M, Waldbaum AS, Labrie C, Cote I, Lavoie L, Martel C, Balser J; VVA Prasterone Group. Decreased efficacy of twice-weekly intravaginal dehydroepiandrosterone on vulvovaginal atrophy. Climacteric. 2015;18(4):590-607. doi: 10.3109/13697137.2014.992012. Epub 2015 Mar 3.'}, {'pmid': '25968836', 'type': 'RESULT', 'citation': 'Portman DJ, Labrie F, Archer DF, Bouchard C, Cusan L, Girard G, Ayotte N, Koltun W, Blouin F, Young D, Wade A, Martel C, Dube R; other participating members of VVA Prasterone Group. Lack of effect of intravaginal dehydroepiandrosterone (DHEA, prasterone) on the endometrium in postmenopausal women. Menopause. 2015 Dec;22(12):1289-95. doi: 10.1097/GME.0000000000000470.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase III trial is to evaluate the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postmenopausal women (non-hysterectomized or hysterectomized)\n* Women between 40 and 75 years of age\n* Willing to participate in the study and sign an informed consent\n* Women who have self-identified symptom(s) of vaginal atrophy\n* For non-hysterectomized women, willing to have endometrial biopsy at baseline and end of study\n\nExclusion Criteria:\n\n* Undiagnosed abnormal genital bleeding\n* Hypertension equal to or above 140/90 mm Hg\n* The administration of any investigational drug within 30 days of screening visit\n* Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening'}, 'identificationModule': {'nctId': 'NCT01358760', 'briefTitle': 'Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'EndoCeutics Inc.'}, 'orgStudyIdInfo': {'id': 'ERC-234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '0.25% DHEA', 'interventionNames': ['Drug: DHEA']}, {'type': 'EXPERIMENTAL', 'label': '0.5% DHEA', 'interventionNames': ['Drug: DHEA']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo vaginal suppository', 'armGroupLabels': ['Placebo']}, {'name': 'DHEA', 'type': 'DRUG', 'otherNames': ['Prasterone, Dehydroepiandrosterone'], 'description': 'Vaginal suppository containing 0.25% (3.25 mg) DHEA', 'armGroupLabels': ['0.25% DHEA']}, {'name': 'DHEA', 'type': 'DRUG', 'otherNames': ['Prasterone, Dehydroepiandrosterone'], 'description': 'Vaginal suppository containing 0.5% (6.5 mg) DHEA', 'armGroupLabels': ['0.5% DHEA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36117', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'EndoCeutics site # 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