Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-29 @ 4:49 AM
Study NCT ID:
NCT01386606
Status:
COMPLETED
Last Update Posted:
2015-09-23
First Post:
2011-06-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064695', 'term': 'Enclomiphene'}, {'id': 'D013739', 'term': 'Testosterone'}], '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'}, {'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': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, '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': 'Androxal 6.25 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks', 'otherNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Androxal 12.5 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks', 'otherNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Androxal 25 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks', 'otherNumAtRisk': 16, 'otherNumAffected': 1, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'AndroGel', 'description': 'AndroGel 5G topical testosterone\n\nTestosterone: topical gel\n\n1X a day 6 weeks', 'otherNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Defaecation urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Libido increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary hesitancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epididymal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '24 Hour Average and Maximum Testosterone Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Androxal 6.25 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG001', 'title': 'Androxal 12.5 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG002', 'title': 'Androxal 25 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG003', 'title': 'AndroGel', 'description': 'AndroGel 5G topical testosterone\n\nTestosterone: topical gel\n\n1X a day 6 weeks'}], 'classes': [{'title': 'TTavg at Baseline', 'categories': [{'measurements': [{'value': '262.3', 'spread': '80.3', 'groupId': 'OG000'}, {'value': '373.6', 'spread': '172.1', 'groupId': 'OG001'}, {'value': '298.3', 'spread': '100.5', 'groupId': 'OG002'}, {'value': '322.4', 'spread': '102.9', 'groupId': 'OG003'}]}]}, {'title': 'TTavg at Week 6', 'categories': [{'measurements': [{'value': '392.4', 'spread': '152.6', 'groupId': 'OG000'}, {'value': '460.8', 'spread': '129.1', 'groupId': 'OG001'}, {'value': '586.7', 'spread': '142.4', 'groupId': 'OG002'}, {'value': '543.9', 'spread': '229.8', 'groupId': 'OG003'}]}]}, {'title': 'TTmax at Baseline', 'categories': [{'measurements': [{'value': '358.5', 'spread': '120.5', 'groupId': 'OG000'}, {'value': '513.7', 'spread': '222.2', 'groupId': 'OG001'}, {'value': '425.9', 'spread': '114.3', 'groupId': 'OG002'}, {'value': '562.3', 'spread': '488.5', 'groupId': 'OG003'}]}]}, {'title': 'TTmax at Week 6', 'categories': [{'measurements': [{'value': '524.5', 'spread': '178.7', 'groupId': 'OG000'}, {'value': '607.5', 'spread': '167.7', 'groupId': 'OG001'}, {'value': '764.3', 'spread': '158.7', 'groupId': 'OG002'}, {'value': '930.1', 'spread': '550.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.056', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value of treatment group.', 'groupDescription': 'Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.\n\nModeling 24 hour average total testosterone by morning testosterone and treatment group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.436', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Regression Coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.77', 'ciLowerLimit': '-143.5', 'ciUpperLimit': '51.98', 'pValueComment': 'P-value for Androxal 25 mg treatment group.', 'groupDescription': 'Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.\n\nModeling 24 hour average total testosterone by morning testosterone and treatment group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.068', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Regression Coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-110.9', 'ciLowerLimit': '-210.6', 'ciUpperLimit': '-11.23', 'pValueComment': 'P-value for Androxal 12.5 mg group.', 'groupDescription': 'Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.\n\nModeling 24 hour average total testosterone by morning testosterone and treatment group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Regression Coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-148.5', 'ciLowerLimit': '-242.9', 'ciUpperLimit': '-54.05', 'pValueComment': 'P-value for Androxal 6.25 mg group.', 'groupDescription': 'Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.\n\nModeling 24 hour average total testosterone by morning testosterone and treatment group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Regression Coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.37', 'ciUpperLimit': '0.79', 'pValueComment': 'P-value for morning total testosterone (adjusted for treatment effect if treatment group is significant).', 'groupDescription': 'Regression of 24 Hours Average Total Testosterone, Treatment Group and Morning Testosterone at Week 6.\n\nModeling 24 hour average total testosterone by morning testosterone and treatment group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment.\n\nTime points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.'}, {'type': 'SECONDARY', 'title': 'Change in Leuteinizing Hormone (LH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Androxal 6.25 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG001', 'title': 'Androxal 12.5 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG002', 'title': 'Androxal 25 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG003', 'title': 'AndroGel', 'description': 'AndroGel 5G topical testosterone\n\nTestosterone: topical gel\n\n1X a day 6 weeks'}], 'classes': [{'title': 'Morning LH at Baseline', 'categories': [{'measurements': [{'value': '3.63', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '4.82', 'spread': '1.63', 'groupId': 'OG001'}, {'value': '4.98', 'spread': '3.45', 'groupId': 'OG002'}, {'value': '3.57', 'spread': '2.23', 'groupId': 'OG003'}]}]}, {'title': 'Morning LH at Week 2', 'categories': [{'measurements': [{'value': '5.49', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '8.60', 'spread': '4.11', 'groupId': 'OG001'}, {'value': '9.64', 'spread': '5.04', 'groupId': 'OG002'}, {'value': '2.00', 'spread': '2.12', 'groupId': 'OG003'}]}]}, {'title': 'Morning LH Change from Baseline at Week 2', 'categories': [{'measurements': [{'value': '1.99', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '3.78', 'spread': '3.29', 'groupId': 'OG001'}, {'value': '4.66', 'spread': '3.56', 'groupId': 'OG002'}, {'value': '-1.57', 'spread': '2.20', 'groupId': 'OG003'}]}]}, {'title': 'Morning LH at Week 4', 'categories': [{'measurements': [{'value': '6.92', 'spread': '3.59', 'groupId': 'OG000'}, {'value': '7.20', 'spread': '2.97', 'groupId': 'OG001'}, {'value': '11.78', 'spread': '7.39', 'groupId': 'OG002'}, {'value': '1.88', 'spread': '2.68', 'groupId': 'OG003'}]}]}, {'title': 'Morning LH Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '3.43', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '2.38', 'spread': '3.54', 'groupId': 'OG001'}, {'value': '6.79', 'spread': '5.54', 'groupId': 'OG002'}, {'value': '-1.69', 'spread': '1.58', 'groupId': 'OG003'}]}]}, {'title': 'Morning LH at Week 6', 'categories': [{'measurements': [{'value': '6.1', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '14.5', 'spread': '10.5', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '2.8', 'groupId': 'OG003'}]}]}, {'title': 'Morning LH Change from Baseline at Week 6', 'categories': [{'measurements': [{'value': '2.60', 'spread': '3.32', 'groupId': 'OG000'}, {'value': '3.39', 'spread': '3.37', 'groupId': 'OG001'}, {'value': '9.51', 'spread': '8.15', 'groupId': 'OG002'}, {'value': '-1.41', 'spread': '2.01', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value for treatment group effect.', 'groupDescription': 'ANOVA results - change from baseline in morning LH at Week 2. Modeling change from baseline by treatment group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value for treatment group effect.', 'groupDescription': 'ANOVA results - change from baseline in morning LH at Week 4. Modeling change from baseline by treatment group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value for treatment group effect.', 'groupDescription': 'ANOVA results - change from baseline in morning LH at Week 6. Modeling change from baseline by treatment group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6', 'description': 'Changes in morning LH after continuous dosing', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.'}, {'type': 'POST_HOC', 'title': 'Morning Testosterone Correlated With Serial Testosterone.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Androxal Pooled Dose Levels', 'description': 'Androxal 6.25, 12.5, and 25 mg subjects combined into a single group.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Pearson Correlation', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.90993', 'groupDescription': 'Pearson correlation between 9 am morning testosterone and serial testosterone Cavg at Week 6.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Pearson Correlation', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.86541', 'groupDescription': 'Pearson correlation between 9 am morning testosterone and serial testosterone Cmin at Week 6.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Pearson Correlation', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.89643', 'groupDescription': 'Pearson correlation between 9 am morning testosterone and serial testosterone Cmax at Week 6.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': '9 AM morning testosterone correlated with Week 6 serial testosterone Cavg, Cmin, and Cmax.\n\nIf a subject did not have a Week 6 serial testosterone Cavg, Cmin, or Cmax then they were not included for that particular correlation calculation.', 'unitOfMeasure': 'Number of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'All Androxal subjects with Week 6 serial testosterone measurements.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Androxal 6.25 mg', 'description': 'Androxal 6.25 mg/day\n\nAndroxal (enclomiphene citrate): capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG001', 'title': 'Androxal 12.5 mg', 'description': 'Androxal 12.5 mg/day\n\nAndroxal (enclomiphene citrate): capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG002', 'title': 'Androxal 25 mg', 'description': 'Androxal 25 mg/day\n\nAndroxal (enclomiphene citrate): capsule oral\n\n1X a day 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8154', 'spread': '0.8358', 'groupId': 'OG000'}, {'value': '3.3899', 'spread': '2.0239', 'groupId': 'OG001'}, {'value': '16.2993', 'spread': '12.8952', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'The Cmax for plasma concentration.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'SECONDARY', 'title': 'Change in Follicle Stimulating Hormone (FSH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Androxal 6.25 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG001', 'title': 'Androxal 12.5 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG002', 'title': 'Androxal 25 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG003', 'title': 'AndroGel', 'description': 'AndroGel 5G topical testosterone\n\nTestosterone: topical gel\n\n1X a day 6 weeks'}], 'classes': [{'title': 'Morning FSH at Baseline', 'categories': [{'measurements': [{'value': '4.61', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '5.63', 'spread': '2.26', 'groupId': 'OG001'}, {'value': '6.31', 'spread': '4.28', 'groupId': 'OG002'}, {'value': '6.38', 'spread': '2.79', 'groupId': 'OG003'}]}]}, {'title': 'Morning FSH at Week 2', 'categories': [{'measurements': [{'value': '6.18', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '7.77', 'spread': '3.03', 'groupId': 'OG001'}, {'value': '11.41', 'spread': '8.19', 'groupId': 'OG002'}, {'value': '3.80', 'spread': '3.06', 'groupId': 'OG003'}]}]}, {'title': 'Morning FSH Change from Baseline at Week 2', 'categories': [{'measurements': [{'value': '1.60', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '2.14', 'spread': '2.15', 'groupId': 'OG001'}, {'value': '5.09', 'spread': '4.32', 'groupId': 'OG002'}, {'value': '-2.58', 'spread': '1.84', 'groupId': 'OG003'}]}]}, {'title': 'Morning FSH at Week 4', 'categories': [{'measurements': [{'value': '6.45', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '7.12', 'spread': '2.66', 'groupId': 'OG001'}, {'value': '12.34', 'spread': '9.59', 'groupId': 'OG002'}, {'value': '3.72', 'spread': '3.66', 'groupId': 'OG003'}]}]}, {'title': 'Morning FSH Change from Baseline at Week 4', 'categories': [{'measurements': [{'value': '1.66', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '1.48', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '6.03', 'spread': '5.90', 'groupId': 'OG002'}, {'value': '-2.66', 'spread': '2.20', 'groupId': 'OG003'}]}]}, {'title': 'Morning FSH at Week 6', 'categories': [{'measurements': [{'value': '5.69', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '8.19', 'spread': '3.25', 'groupId': 'OG001'}, {'value': '13.45', 'spread': '10.84', 'groupId': 'OG002'}, {'value': '3.35', 'spread': '3.34', 'groupId': 'OG003'}]}]}, {'title': 'Morning FSH Change from Baseline at Week 6', 'categories': [{'measurements': [{'value': '1.42', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '2.56', 'spread': '2.53', 'groupId': 'OG001'}, {'value': '7.14', 'spread': '7.19', 'groupId': 'OG002'}, {'value': '-3.03', 'spread': '2.21', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value for treatment group effect.', 'groupDescription': 'ANOVA results - change from baseline in morning FSH at Week 2. Modeling change from baseline by treatment group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value for treatment group effect.', 'groupDescription': 'ANOVA results - change from baseline in morning FSH at Week 4. Modeling change from baseline by treatment group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'P-value for treatment group effect.', 'groupDescription': 'ANOVA results - change from baseline in morning FSH at Week 6. Modeling change from baseline by treatment group.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6', 'description': 'Changes in morning FSH after continuous dosing', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, subjects who received at least one dose of study drug and had at least one post-dose efficacy measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Androxal 6.25 mg', 'description': 'Androxal 6.25 mg/day\n\nAndroxal (enclomiphene citrate): capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG001', 'title': 'Androxal 12.5 mg', 'description': 'Androxal 12.5 mg/day\n\nAndroxal (enclomiphene citrate): capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG002', 'title': 'Androxal 25 mg', 'description': 'Androxal 25 mg/day\n\nAndroxal (enclomiphene citrate): capsule oral\n\n1X a day 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '2.42', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '2.41', 'spread': '1.48', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'The Tmax for plasma concentration.', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Androxal 6.25 mg', 'description': 'Androxal 6.25 mg/day\n\nAndroxal (enclomiphene citrate): capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG001', 'title': 'Androxal 12.5 mg', 'description': 'Androxal 12.5 mg/day\n\nAndroxal (enclomiphene citrate): capsule oral\n\n1X a day 6 weeks'}, {'id': 'OG002', 'title': 'Androxal 25 mg', 'description': 'Androxal 25 mg/day\n\nAndroxal (enclomiphene citrate): capsule oral\n\n1X a day 6 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '21.200', 'spread': '14.399', 'groupId': 'OG000'}, {'value': '34.012', 'spread': '21.419', 'groupId': 'OG001'}, {'value': '150.51', 'spread': '132.32', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 6', 'description': 'The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24).', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Androxal 6.25 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'FG001', 'title': 'Androxal 12.5 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'FG002', 'title': 'Androxal 25 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'FG003', 'title': 'AndroGel', 'description': 'AndroGel 5G topical testosterone\n\nTestosterone: topical gel\n\n1X a day 6 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject incarcerated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Unable to draw PK', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'T levels too high', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Androxal 6.25 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'BG001', 'title': 'Androxal 12.5 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'BG002', 'title': 'Androxal 25 mg', 'description': 'enclomiphene citrate: capsule oral\n\n1X a day 6 weeks'}, {'id': 'BG003', 'title': 'AndroGel', 'description': 'AndroGel 5G topical testosterone\n\nTestosterone: topical gel\n\n1X a day 6 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '51.7', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '51.8', 'spread': '13.0', 'groupId': 'BG002'}, {'value': '53.5', 'spread': '9.8', 'groupId': 'BG003'}, {'value': '52.6', 'spread': '10.2', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '31.2', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '31.6', 'spread': '6.3', 'groupId': 'BG002'}, {'value': '31.0', 'spread': '6.1', 'groupId': 'BG003'}, {'value': '31.8', 'spread': '6.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The baseline analysis consisted of all subjects enrolled.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-21', 'studyFirstSubmitDate': '2011-06-29', 'resultsFirstSubmitDate': '2014-06-13', 'studyFirstSubmitQcDate': '2011-06-29', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-21', 'studyFirstPostDateStruct': {'date': '2011-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Enclomiphene Pharmacokinetic Parameters at Week 6 - Cmax.', 'timeFrame': 'Week 6', 'description': 'The Cmax for plasma concentration.'}, {'measure': 'Enclomiphene Pharmacokinetic Parameters at Week 6 - Tmax.', 'timeFrame': 'Week 6', 'description': 'The Tmax for plasma concentration.'}, {'measure': 'Enclomiphene Pharmacokinetic Parameters at Week 6 - AUC0-24.', 'timeFrame': 'Week 6', 'description': 'The area under the curve for plasma concentration over time from zero to 24 hours (AUC0-24).'}], 'primaryOutcomes': [{'measure': '24 Hour Average and Maximum Testosterone Concentration', 'timeFrame': 'Baseline and Week 6', 'description': 'The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment.\n\nTime points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.'}], 'secondaryOutcomes': [{'measure': 'Change in Leuteinizing Hormone (LH)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6', 'description': 'Changes in morning LH after continuous dosing'}, {'measure': 'Change in Follicle Stimulating Hormone (FSH)', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6', 'description': 'Changes in morning FSH after continuous dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Secondary Hypogonadism']}, 'descriptionModule': {'briefSummary': 'The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\\<350 ng/dL)after 6 weeks of continuous dosing.', 'detailedDescription': 'Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL.\n* All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)\n* Ability to complete the study in compliance with the protocol\n* Ability to understand and provide written informed consent\n* Agreement to use a condom, and with a fertile female partner, another form of contraception.\n* Agreement to provide a semen sample in the clinic\n\nExclusion Criteria:\n\n* Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study\n* Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study\n* Use of Clomid in the past year or during the study\n* Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.\n* A hematocrit ≥51 % or a hemoglobin ≥17 g/dL\n* Clinically significant abnormal findings on screening examination\n* Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication\n* Known hypersensitivity to Clomid\n* Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study\n* Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary)\n* History of breast cancer\n* History of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA \\>3.6\n* History of known hyperprolactinemia with or without a tumor\n* Chronic use of medications use such as glucocorticoids\n* Chronic use of narcotics\n* Subjects known to be positive for HIV\n* Subjects with end stage renal disease\n* Subjects with cystic fibrosis (mutation of the CFTR gene)\n* Subjects unable to provide a semen sample in the clinic\n* Subject has a BMI \\>42 kg/m2"}, 'identificationModule': {'nctId': 'NCT01386606', 'briefTitle': 'The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Repros Therapeutics Inc.'}, 'officialTitle': 'A Randomized, Single Blind, Multi-Center Phase II Study to Evaluate the Effect of Three Different Doses of Androxal and AndroGel on 24-Hour Luteinizing Hormone and Testosterone in Normal Healthy Men', 'orgStudyIdInfo': {'id': 'ZA-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Androxal 6.25 mg', 'description': 'Androxal 6.25 mg/day', 'interventionNames': ['Drug: Androxal (enclomiphene citrate)']}, {'type': 'EXPERIMENTAL', 'label': 'Androxal 12.5 mg', 'description': 'Androxal 12.5 mg/day', 'interventionNames': ['Drug: Androxal (enclomiphene citrate)']}, {'type': 'EXPERIMENTAL', 'label': 'Androxal 25 mg', 'description': 'Androxal 25 mg/day', 'interventionNames': ['Drug: Androxal (enclomiphene citrate)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AndroGel', 'description': 'AndroGel 5G topical testosterone', 'interventionNames': ['Drug: Testosterone']}], 'interventions': [{'name': 'Androxal (enclomiphene citrate)', 'type': 'DRUG', 'otherNames': ['Androxal', 'low testosterone therapy'], 'description': 'capsule oral\n\n1X a day 6 weeks', 'armGroupLabels': ['Androxal 12.5 mg', 'Androxal 25 mg', 'Androxal 6.25 mg']}, {'name': 'Testosterone', 'type': 'DRUG', 'otherNames': ['topical testosterone', 'testosterone gel', 'exogenous testosterone'], 'description': 'topical gel\n\n1X a day 6 weeks', 'armGroupLabels': ['AndroGel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77062', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Centex Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cetero Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Jolene Berg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cetero Research, San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Repros Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}