Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-02 @ 1:45 PM
Study NCT ID:
NCT00361569
Status:
COMPLETED
Last Update Posted:
2015-04-20
First Post:
2006-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C509653', 'term': 'estrogens, conjugated synthetic A'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalaffairs@barrlabs.com', 'phone': '215-293-7279', 'title': 'Duramed Research Protocol Chair', 'organization': 'Duramed Research'}, 'certainAgreement': {'otherDetails': 'The sponsor can (i) review results communications prior to public release and can embargo communications regarding trial results for a period of at least 60 days but no more than 180 days from the time submitted to the sponsor for review; and (ii) require in instances of a multi-center study, that a single PI not disclose study data until after the multi-center results are published, provided such results are published within eighteen (18) months of the conclusion of the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event reporting began on the first day of signing the informed consent and ended at the end of study drug treatment (approximately 16 weeks).', 'description': "Adverse events were reported during the subject's regularly scheduled visits at the investigational site. Adverse events reported are those that emerged during the treatment period.", 'eventGroups': [{'id': 'EG000', 'title': 'DR-2041a', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter', 'otherNumAtRisk': 150, 'otherNumAffected': 34, 'seriousNumAtRisk': 150, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'DR-2041b', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter', 'otherNumAtRisk': 161, 'otherNumAffected': 36, 'seriousNumAtRisk': 161, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo-a', 'description': '1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter', 'otherNumAtRisk': 155, 'otherNumAffected': 18, 'seriousNumAtRisk': 155, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo-b', 'description': '2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter', 'otherNumAtRisk': 156, 'otherNumAffected': 33, 'seriousNumAtRisk': 156, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Genital Pruritus Female', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vulvovaginal Mycotic Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'seriousEvents': [{'term': 'Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Chronic Sinusitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': "Hodgkin's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 156, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change in the Symptom Identified by the Patient to be Most Bothersome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DR-2041a', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'OG001', 'title': 'DR-2041b', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'OG002', 'title': 'Placebo-a', 'description': '1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'OG003', 'title': 'Placebo-b', 'description': '2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.71', 'spread': '0.0087', 'groupId': 'OG000'}, {'value': '-1.77', 'spread': '0.085', 'groupId': 'OG001'}, {'value': '-1.11', 'spread': '0.086', 'groupId': 'OG002'}, {'value': '-1.10', 'spread': '0.087', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modifed Intent-to-Treat: All subjects meeting study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, randomized to treatment, received at least 1 dose of study drug, and had a baseline assessment and at least 1 post-randomization assessment of vulvovaginal atrophy consisting of all 3 co-primary efficacy endpoints'}, {'type': 'PRIMARY', 'title': 'Mean Change in Vaginal pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DR-2041a', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'OG001', 'title': 'DR-2041b', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'OG002', 'title': 'Placebo-a', 'description': '1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'OG003', 'title': 'Placebo-b', 'description': '2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.48', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '-1.44', 'spread': '0.071', 'groupId': 'OG001'}, {'value': '-0.31', 'spread': '0.072', 'groupId': 'OG002'}, {'value': '-0.38', 'spread': '0.073', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Change= Week 12 vaginal pH - Baseline vaginal pH', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modifed Intent-to-Treat: All subjects who met study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, who were randomized to treatment, received at least 1 dose of study drug, for whom there were a baseline assessment and at least 1 post-randomization assessment of VVA consisting of all 3 co-primary efficacy endpoints'}, {'type': 'PRIMARY', 'title': 'Mean Change in Maturation Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DR-2041a', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'OG001', 'title': 'DR-2041b', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'OG002', 'title': 'Placebo-a', 'description': '1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'OG003', 'title': 'Placebo-b', 'description': '2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '31.46', 'spread': '1.221', 'groupId': 'OG000'}, {'value': '33.27', 'spread': '1.191', 'groupId': 'OG001'}, {'value': '5.16', 'spread': '1.205', 'groupId': 'OG002'}, {'value': '8.91', 'spread': '1.222', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells \\* 0) + (% Intermediate Cells \\* 0.5) + (% Superficial Cells \\* 1.0)', 'unitOfMeasure': 'Index', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modifed Intent-to-Treat: All subjects who met study protocol requirements at baseline for all 3 primary efficacy inclusion criteria, who were randomized to treatment, received at least 1 dose of study drug, for whom there were a baseline assessment and at least 1 post-randomization assessment of VVA consisting of all 3 co-primary efficacy endpoints'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DR-2041a', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'OG001', 'title': 'DR-2041b', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'OG002', 'title': 'Placebo-a', 'description': '1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'OG003', 'title': 'Placebo-b', 'description': '2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 12', 'description': "Any adverse event reported from the beginning of the 28-day screening through the subject's last report.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects who received at least one dose of study medication'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DR-2041a', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'FG001', 'title': 'DR-2041b', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'FG002', 'title': 'Placebo-a', 'description': '1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'FG003', 'title': 'Placebo-b', 'description': '2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '161'}, {'groupId': 'FG002', 'numSubjects': '155'}, {'groupId': 'FG003', 'numSubjects': '156'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '137'}, {'groupId': 'FG003', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Not specified by investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}, {'value': '622', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'DR-2041a', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'BG001', 'title': 'DR-2041b', 'description': 'Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'BG002', 'title': 'Placebo-a', 'description': '1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'BG003', 'title': 'Placebo-b', 'description': '2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'spread': '6.48', 'groupId': 'BG000'}, {'value': '59.3', 'spread': '6.10', 'groupId': 'BG001'}, {'value': '59.8', 'spread': '6.60', 'groupId': 'BG002'}, {'value': '58.4', 'spread': '6.28', 'groupId': 'BG003'}, {'value': '59.4', 'spread': '6.36', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Between 30 and 80 years', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}, {'value': '622.0', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}, {'value': '622.0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0.0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}, {'value': '622.0', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 622}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-30', 'studyFirstSubmitDate': '2006-08-03', 'resultsFirstSubmitDate': '2008-12-22', 'studyFirstSubmitQcDate': '2006-08-04', 'lastUpdatePostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-03-12', 'studyFirstPostDateStruct': {'date': '2006-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change in the Symptom Identified by the Patient to be Most Bothersome', 'timeFrame': 'Baseline to Week 12', 'description': 'Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.'}, {'measure': 'Mean Change in Vaginal pH', 'timeFrame': 'Baseline to Week 12', 'description': 'Change= Week 12 vaginal pH - Baseline vaginal pH'}, {'measure': 'Mean Change in Maturation Index', 'timeFrame': 'Baseline to Week 12', 'description': 'Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells \\* 0) + (% Intermediate Cells \\* 0.5) + (% Superficial Cells \\* 1.0)'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)', 'timeFrame': 'Up to Week 12', 'description': "Any adverse event reported from the beginning of the 28-day screening through the subject's last report."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vaginal atrophy', 'vaginal dryness', 'vaginal itching', 'vaginal pain'], 'conditions': ['Menopause']}, 'referencesModule': {'references': [{'pmid': '19252451', 'type': 'RESULT', 'citation': 'Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H. Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause. 2009 Jul-Aug;16(4):735-41. doi: 10.1097/gme.0b013e318199e734.'}]}, 'descriptionModule': {'briefSummary': 'This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.', 'detailedDescription': 'The study will include a screening period up to 4 weeks and a 12- week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. All patients with a uterus will undergo transvaginal ultrasound.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Naturally or surgically menopausal\n* Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)\n\nExclusion Criteria:\n\n* Known sensitivity or contraindication to estrogens or progestins\n* History or current diagnosis endometrial hyperplasia\n* Recent history of vaginal bleeding of unknown cause\n* Recent history or diagnosis of endometriosis\n* Any contraindication to estrogen therapy'}, 'identificationModule': {'nctId': 'NCT00361569', 'briefTitle': 'A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment With DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women', 'orgStudyIdInfo': {'id': 'DR-CEN-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: DR-2041a']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: DR-2041b']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'interventionNames': ['Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'DR-2041a', 'type': 'DRUG', 'otherNames': ['Synthetic conjugated estrogens, A'], 'description': '1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter', 'armGroupLabels': ['1']}, {'name': 'DR-2041b', 'type': 'DRUG', 'otherNames': ['Synthetic conjugated estrogens, A'], 'description': '2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter', 'armGroupLabels': ['3']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36608', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '85015', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85031', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94583', 'city': 'San Ramon', 'state': 'California', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 37.77993, 'lon': -121.97802}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '81001', 'city': 'Pueblo', 'state': 'Colorado', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 38.25445, 'lon': -104.60914}}, {'zip': '06320', 'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33759', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34748', 'city': 'Leesburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 28.81082, 'lon': -81.87786}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '34996', 'city': 'Stuart', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 27.19755, 'lon': -80.25283}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '34292', 'city': 'Venice', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 27.09978, 'lon': -82.45426}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '30005', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30034', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '30134', 'city': 'Douglasville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 33.7515, 'lon': -84.74771}}, {'zip': '30328', 'city': 'Sandy Springs', 'state': 'Georgia', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '66215', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40291', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '42431', 'city': 'Madisonville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 37.3281, 'lon': -87.49889}}, {'zip': '71106', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48152', 'city': 'Livonia', 'state': 'Michigan', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 42.36837, 'lon': -83.35271}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '89146', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '08057', 'city': 'Moorestown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 39.96706, 'lon': -74.94267}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '13790', 'city': 'Johnson City', 'state': 'New York', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 42.11563, 'lon': -75.95881}}, {'zip': '14221', 'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58401', 'city': 'Jamestown', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 46.91054, 'lon': -98.70844}}, {'zip': '58701', 'city': 'Minot', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 48.23251, 'lon': -101.29627}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44122', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43213', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '44124', 'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18104', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '19406', 'city': 'King of Prussia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 40.08927, 'lon': -75.39602}}, {'zip': '19063', 'city': 'Media', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 39.91678, 'lon': -75.38769}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19114', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15206', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '19010', 'city': 'Rosemont', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 40.02567, 'lon': -75.3238}}, {'zip': '19087', 'city': 'Strafford', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 40.05094, 'lon': -75.40436}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29425-0100', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29201', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '57201', 'city': 'Watertown', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 44.89941, 'lon': -97.11507}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78748', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78414', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '75390-9032', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77015', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76712', 'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '05495', 'city': 'Williston', 'state': 'Vermont', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 44.43755, 'lon': -73.06818}}, {'zip': '23602', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '99207', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Duramed Investigational Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Duramed Protocol Chair', 'role': 'STUDY_CHAIR', 'affiliation': 'Duramed Research, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duramed Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Duramed Protocol Chair', 'oldOrganization': 'Duramed Research, Inc.'}}}}