Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT01191320
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2010-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064695', 'term': 'Enclomiphene'}], 'ancestors': [{'id': 'D002996', 'term': 'Clomiphene'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jwike@reprosrx.com', 'phone': '281-719-3402', 'title': 'Jennifer L. Wike', 'organization': 'Repros Therapeutics Inc.'}, 'certainAgreement': {'otherDetails': "Prior to publication, Investigator shall submit to the Sponsor a copy of any proposed publication. Sponsor shall have sixty (60) days to review the proposed publication for possible disclosure of Sponsor's Confidential Information and, upon request of Sponsor, Investigator shall delete any of Sponsor's Confidential Information or withhold submission of such publication to allow Sponsor to protect its intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo capsule 1x daily for 3 months', 'otherNumAtRisk': 43, 'otherNumAffected': 1, 'seriousNumAtRisk': 43, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Androxal 12.5 mg', 'description': '12.5 mg/day\n\nAndroxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months', 'otherNumAtRisk': 38, 'otherNumAffected': 8, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Androxal 25 mg', 'description': '25 mg/day\n\nAndroxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months', 'otherNumAtRisk': 38, 'otherNumAffected': 5, 'seriousNumAtRisk': 38, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Glycosylated Hemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Coronary bypass', 'notes': 'Subject was hospitalized for triple bypass surgery considered by PI to be unrelated to treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Angina pectoris', 'notes': 'Subject was hospitalized for severe chest pain. Study drug was continued. PI assessed as not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HbA1C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo capsule 1x daily for 3 months'}, {'id': 'OG001', 'title': 'Androxal 12.5 mg', 'description': '12.5 mg/day\n\nAndroxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months'}, {'id': 'OG002', 'title': 'Androxal 25 mg', 'description': '25 mg/day\n\nAndroxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0.012', 'groupId': 'OG000'}, {'value': '0', 'spread': '0.015', 'groupId': 'OG001'}, {'value': '0', 'spread': '0.010', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The change in HbA1c from Baseline to 3 Months for each treatment arm', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo capsule 1x daily for 3 months'}, {'id': 'FG001', 'title': 'Androxal 12.5 mg', 'description': '12.5 mg/day\n\nAndroxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months'}, {'id': 'FG002', 'title': 'Androxal 25 mg', 'description': '25 mg/day\n\nAndroxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: Placebo capsule 1x daily for 3 months'}, {'id': 'BG001', 'title': 'Androxal 12.5 mg', 'description': '12.5 mg/day\n\nAndroxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months'}, {'id': 'BG002', 'title': 'Androxal 25 mg', 'description': '25 mg/day\n\nAndroxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.3', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '55.9', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '8.4', 'groupId': 'BG002'}, {'value': '57.0', 'spread': '8.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '119', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HgbA1c ratio', 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.012', 'groupId': 'BG000'}, {'value': '0.08', 'spread': '0.013', 'groupId': 'BG001'}, {'value': '0.09', 'spread': '0.017', 'groupId': 'BG002'}, {'value': '0.08', 'spread': '0.014', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-27', 'studyFirstSubmitDate': '2010-08-27', 'resultsFirstSubmitDate': '2014-06-18', 'studyFirstSubmitQcDate': '2010-08-27', 'lastUpdatePostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-27', 'studyFirstPostDateStruct': {'date': '2010-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1C', 'timeFrame': '3 months', 'description': 'The change in HbA1c from Baseline to 3 Months for each treatment arm'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adult onset hypogonadotropic hypogonadism'], 'conditions': ['Type 2 Diabetes Mellitus', 'Secondary Hypogonadism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism', 'detailedDescription': 'A phase IIB, multi-center, randomized, parallel, placebo- and active-controlled trial in adult male subjects with secondary hypogonadism who have been treated with OHAs but are not in glycemic control. All subjects currently treated with exogenous testosterone will discontinue at screening for at least 21 days and remain off testosterone for the course of the study. One hundred twenty to 150 subjects will be randomly assigned to one of three treatment groups according to a 1:1:1 ratio. Subjects will receive one of two dose strengths of Androxal or placebo in addition to their usual dose of mono- or combination OHAs for three months. Following an initial screening period, subjects will return monthly for 3 months and 1 month later for a follow-up visit.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males, ages 20 to 80-years-old, inclusive\n* A diagnosis of type 2 diabetes mellitus by American Diabetes Association (ADA) criteria for at least 6 months\n* Treatment with a stable but sub-optimum dose of OHAs for at least 2 months prior to screening based on a lack of control of blood glucose\n* Previous diagnosis of adult-onset idiopathic hypogonadotropic hypogonadism (AIHH) and have undergone treatment with a topical testosterone gel, Low-to-borderline morning total testosterone (TT), after at least a two week wash-out period, and normal or low normal serum luteinizing hormone (LH)at screening and at baseline\n* No previous diagnosis of AIHH but present as naïve patients with low morning TT and normal or low normal serum LH at screening and at baseline\n* Body Mass Index (BMI) between 26 and 40 kg/m2\n* Fasting blood (plasma or serum) glucose (FBG) between 125 and 240 mg/dL\n* HemoglobinA1c in serum as (HbA1c) between 7% and 9.5%\n* Comprehends informed consent\n* Otherwise normal healthy males\n* All clinical laboratory test within normal ranges (any deviation outside the normal range will require approval of investigator)\n* Ability to complete the study in compliance with the protocol\n* Ability to understand and provide written informed consent\n\nExclusion Criteria:\n\n* A history of testicular failure, Kallmann Syndrome or other infertility condition\n* Clinically significant medical condition rendering the subjects infertile including tumors of the pituitary, laboratory abnormalities, or having received an investigational drug in the past 30 days prior to study\n* Prostate nodules or induration, a history of, known, or suspect prostate cancer not ruled out by a negative biopsy, or a prostate specific antigen (PSA) higher than 3.5;\n* Hematocrit in excess of 47% or a hemoglobin (Hb) greater than 16 g/dl\n* Previous treatment with androgens, estrogens, DHEA, testosterone or testosterone analogues in injectable, oral, topical or other forms for the treatment of AIHH who have not discontinued at the start of the treatment phase;\n* Primary hypogonadism as typified as a serum LH greater than 15 and a TT value less than 300 ng/dL\n* Continuous use of corticosteroids\n* History of or current diagnosis of major macrovascular complications of T2DM: myocardial infarction (MI) or stroke within 6 months, or any history of coronary revascularization, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) greater than or equal to 2\n* Uncontrolled sitting blood pressure (BP) greater than 150/95, serum creatinine (Cr) greater than 1.5 ULN or estimated glomerular filtration rate (eGFR) less than mL/min/1.73 m2\n* Retinopathy requiring continuing ophthalmologic assessments\n* Cataracts\n* Other significant history of diabetic complications (proteinuria greater than 1 g/d, retinopathy, clear neuropathy)\n* Aspartate transaminase (AST), alanine transaminase (ALT), or alkaline phosphatase greater than 3 times the upper limits of normal (ULN)\n* Total bilirubin greater than 2.0 mg/dL (\\>34 µmol/L);\n* Injectable testosterone within 120 days of Screening (Visit 1)\n* Reported substance abuse at screening\n* Taking insulin therapy;\n* Clinically significant abnormal findings on screening examination as determined by the investigator\n* Known hypersensitivity to clomiphene citrate;\n* Current or history of breast cancer\n* Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with the study instructions, possibly confound interpretation of the study results, or endanger the participant if he took part in the study."}, 'identificationModule': {'nctId': 'NCT01191320', 'briefTitle': 'Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Repros Therapeutics Inc.'}, 'officialTitle': 'A Study to Evaluate the Efficacy of Androxal® in Improving Glycemic Control in Men With Secondary Hypogonadism or Adult-onset Idiopathic Hypogonadotropic Hypogonadism (AIHH) and Type 2 Diabetes Mellitus With Sub-Optimum Treatment', 'orgStudyIdInfo': {'id': 'ZA-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Androxal 12.5 mg', 'description': '12.5 mg/day', 'interventionNames': ['Drug: Androxal']}, {'type': 'EXPERIMENTAL', 'label': 'Androxal 25 mg', 'description': '25 mg/day', 'interventionNames': ['Drug: Androxal']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule 1x daily for 3 months', 'armGroupLabels': ['Placebo']}, {'name': 'Androxal', 'type': 'DRUG', 'otherNames': ['Enclomiphene citrate'], 'description': 'Capsules 12.5 mg or 25 mg 1x daily for 3 months', 'armGroupLabels': ['Androxal 12.5 mg', 'Androxal 25 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92844', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Paradigm Clinical Research', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Research Corp', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'LABioMed', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '01960', 'city': 'Peabody', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic', 'geoPoint': {'lat': 42.52787, 'lon': -70.92866}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Affiliated Clinical Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89144', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Affiliated Clinical Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Dr. Bruce Gilbert', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'University Urology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10577', 'city': 'Purchase', 'state': 'New York', 'country': 'United States', 'facility': 'Dr. Michael Werner', 'geoPoint': {'lat': 41.04093, 'lon': -73.71457}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Discovery Clinical Trials', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75010', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Across America', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'TX Urology Associate', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77062', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Centex Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77095', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Dr. Rakesh Patel', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76054', 'city': 'Hurst', 'state': 'Texas', 'country': 'United States', 'facility': 'Protenium Clinical Research', 'geoPoint': {'lat': 32.82346, 'lon': -97.17057}}, {'zip': '77566', 'city': 'Lake Jackson', 'state': 'Texas', 'country': 'United States', 'facility': 'R/D Clinical Research', 'geoPoint': {'lat': 29.03386, 'lon': -95.43439}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cetero Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Glenn Cunningham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Repros Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}