Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-28 @ 4:12 AM
Study NCT ID:
NCT00729859
Status:
COMPLETED
Last Update Posted:
2012-10-12
First Post:
2008-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C109238', 'term': 'acyline'}, {'id': 'D000077384', 'term': 'Anastrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'page@u.washington.edu', 'phone': '206-616-0483', 'title': 'Stephanie T. Page, MD, PhD', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Dec 2008 - May 2010', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: Acyline + Placebo Gel, Placebo Pill', 'description': 'Acyline 300 µg/kg injections Day 0 \\& 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days', 'otherNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2: Acyline, Testosterone Gel, Placebo Pill', 'description': 'Acyline 300 µg/kg injections Day 0 \\& 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3: Acyline, Testosterone Gel, Anastrazole Pill', 'description': 'Acyline 300 μg/kg injections Day 0 \\& 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days', 'otherNumAtRisk': 8, 'otherNumAffected': 2, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'emotional lability, irritability', 'notes': 'This is expected in group 1 subjects (hypogonadal). The group 3 subject with emotional lability also reported skin irritation at the testosterone gel site.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'notes': 'Fatigue is anticipated and consistent with hypogonadal symptoms for Group 1 (placebo gel. The group 2 subject also reported studying late and spending the night in the library during midterm week. Fatigue is described in the consent as a possibility.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hot flashes', 'notes': 'Hot flashes are anticipated and consistent with hypogonadal symptoms for Group 1 (placebo gel). This is described in the consent.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'itching at acyline site', 'notes': 'The written consent describes itchiness at the site in most men. One (group 2)is not counted here, but is described in "participant flow". Symptoms had resolved on Day 14 but he withdrew consent before the second acyline injection.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lightheadedness, clammy', 'notes': 'Mild symptoms occurred two days and were deemed possibly related to the drug. No action or medications were required in this group I (hypogonadal symptoms expected) subject.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'low libido', 'notes': 'Low libido is anticipated and consistent with hypogonadal symptoms for Group 1 (placebo gel). This is described in the consent.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'skin irritation, gel application site', 'notes': 'One(group 1) complaint of itchiness;one(group 3) complaint of dry skin at testosterone gel application site. Both subjects were instructed to apply elsewhere; complaints were resolved with no further symptoms at old and new application sites.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'itching rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Endothelial Progenitor Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Acyline + Placebo Gel + Placebo Pill', 'description': 'Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG001', 'title': 'Group 2: Acyline + T-gel 10g/Day + Placebo Pill', 'description': 'Acyline SQ inj. Day 0 \\& 14 + T-gel and placebo pill for 28 days'}, {'id': 'OG002', 'title': 'Group 3: Acyline + T-gel + Oral Anastrozole 1mg', 'description': 'Acyline SQ inj. Day 0 \\& 14 + T-gel and anastrozole for 28 days'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.101', 'spread': '0.032', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0.081', 'spread': '0.040', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '0.005', 'ciUpperLimit': '0.035', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.0075', 'groupDescription': 'p value for the difference = 0.28', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 28', 'description': 'Number of CD33 + CD134+ cells as a percentage of all lymphocytes', 'unitOfMeasure': 'percentage of all lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical analyses were limited to changes from baseline within a given group and between-group comparisons were not performed'}, {'type': 'SECONDARY', 'title': 'Follicle Stimulating Hormone (FSH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Acyline + Placebo Gel, Placebo Pill', 'description': 'Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG001', 'title': 'Group 2: Acyline, Testosterone Gel', 'description': 'Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG002', 'title': 'Group 3: Acyline, Testosterone Gel, Anastrazole Pill', 'description': 'Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrazole pill 1 mg for 28 days'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 28 days', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.'}, {'type': 'SECONDARY', 'title': 'Luteinizing Hormone Concentration (LH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Acyline + Placebo Gel, Placebo Pill', 'description': 'Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG001', 'title': 'Group 2: Acyline, Testosterone Gel', 'description': 'Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG002', 'title': 'Group 3: Acyline, Testosterone Gel, Anastrozole', 'description': 'Arm 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.3', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '1.55', 'spread': '1.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 28', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was per protocol. Following screening, the first 8 subjects were assigned to group I, and subsequent subjects enrolled were randomly assigned to either group 2 or 3.'}, {'type': 'SECONDARY', 'title': 'Testosterone Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Acyline + Placebo Gel, Placebo Pill', 'description': 'Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG001', 'title': 'Group 2: Acyline, Testosterone Gel', 'description': 'Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG002', 'title': 'Group 3: Acyline, Testosterone Gel, Anastrozole', 'description': 'Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.'}], 'classes': [{'title': 'Baseline testosterone concentration', 'categories': [{'measurements': [{'value': '15.4', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '16.5', 'spread': '2.6', 'groupId': 'OG002'}]}]}, {'title': 'Day 28 testosterone concentration', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '19.0', 'spread': '7.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 28', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, the first 8 subjects were assigned to group I. Subsequent subjects were randomized to group 2 or group 3.'}, {'type': 'SECONDARY', 'title': 'Estradiol Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Acyline + Placebo Gel, Placebo Pill', 'description': 'Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG001', 'title': 'Group 2: Acyline, Testosterone Gel', 'description': 'Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG002', 'title': 'Group 3: Acyline, Testosterone Gel, Anastrozole Pill', 'description': 'Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '95.4', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '117.8', 'spread': '28.6', 'groupId': 'OG001'}, {'value': '96.3', 'spread': '21.9', 'groupId': 'OG002'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '31.9', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '109.0', 'spread': '28.8', 'groupId': 'OG001'}, {'value': '36.5', 'spread': '14.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 28', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, the first 8 subjects were assigned to Group 1. Subsequent subjects were randomly assigned to Group 2 or Group 3.'}, {'type': 'SECONDARY', 'title': 'Sex Hormone Binding Globulin (SHBG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Acyline + Placebo Gel, Placebo Pill', 'description': 'Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG001', 'title': 'Group 2: Acyline, Testosterone Gel', 'description': 'Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG002', 'title': 'Group 3: Acyline, Testosterone Gel, Anastrozole Pill', 'description': 'Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '34.9', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '23.0', 'spread': '10.9', 'groupId': 'OG001'}, {'value': '27.6', 'spread': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '37.5', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '22.1', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '25.1', 'spread': '4.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 28', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, the first 8 subjects were assigned to Group I. Subsequent subjects were randomly assigned to Group 2 or Group 3.'}, {'type': 'SECONDARY', 'title': 'Quantitative Insulin Sensitivity Check Index (QUICKI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Acyline + Placebo Gel, Placebo Pill', 'description': 'Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG001', 'title': 'Group 2: Acyline, Testosterone Gel, Placebo Pill', 'description': 'Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG002', 'title': 'Group 3: Acyline, Testosterone Gel, Oral Anastrozole', 'description': 'Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '0.02', 'groupId': 'OG002'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '0.02', 'groupId': 'OG002'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '0.02', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 28, Day 56', 'description': 'QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity.', 'unitOfMeasure': 'QUICKI index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Homeostasis Model of Insulin Resistance (HOMA-IR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Acyline + Placebo Gel, Placebo Pill', 'description': 'Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG001', 'title': 'Group 2: Acyline, Testosterone Gel, Placebo Pill', 'description': 'Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG002', 'title': 'Group 3: Acyline, Testosterone Gel, Oral Anastrozole', 'description': 'Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 28, Day 56', 'description': 'HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity.', 'unitOfMeasure': 'HOMA score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Fasting Serum Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Acyline + Placebo Gel, Placebo Pill', 'description': 'Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG001', 'title': 'Group 2: Acyline, Testosterone Gel, Placebo Pill', 'description': 'Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG002', 'title': 'Group 3: Acyline, Testosterone Gel, Oral Anastrozole', 'description': 'Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '54', 'spread': '26', 'groupId': 'OG000'}, {'value': '65', 'spread': '28', 'groupId': 'OG001'}, {'value': '50', 'spread': '16', 'groupId': 'OG002'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '69', 'spread': '25', 'groupId': 'OG000'}, {'value': '59', 'spread': '26', 'groupId': 'OG001'}, {'value': '42', 'spread': '23', 'groupId': 'OG002'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '54', 'spread': '26', 'groupId': 'OG000'}, {'value': '64', 'spread': '27', 'groupId': 'OG001'}, {'value': '50', 'spread': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 28, Day 56', 'unitOfMeasure': 'picomolar', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Fasting Lipid Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Acyline + Placebo Gel, Placebo Pill', 'description': 'Group 1: Acyline injections, transdermal placebo gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG001', 'title': 'Group 2: Acyline, Testosterone Gel, Placebo Pill', 'description': 'Group 2: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily placebo pill for 28 days'}, {'id': 'OG002', 'title': 'Group 3: Acyline, Testosterone Gel, Oral Anastrozole', 'description': 'Group 3: Acyline injections, transdermal testosterone gel 10 g/day for 28 days, oral daily anastrozole pill 1 mg for 28 days.'}], 'classes': [{'title': 'Total cholesterol Day 0', 'categories': [{'measurements': [{'value': '4.97', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.48', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '4.56', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': 'Total cholesterol Day 28', 'categories': [{'measurements': [{'value': '5.44', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.51', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '4.56', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Total cholesterol Day 56', 'categories': [{'measurements': [{'value': '4.95', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '4.14', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.27', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'LDL choesterol Day 0', 'categories': [{'measurements': [{'value': '2.95', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '2.67', 'spread': '1.3', 'groupId': 'OG002'}]}]}, {'title': 'LDL cholesterol Day 28', 'categories': [{'measurements': [{'value': '3.29', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.80', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '2.75', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'LDL cholesterol Day 56', 'categories': [{'measurements': [{'value': '2.87', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.49', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '2.51', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': 'HDL cholesterol Day 0', 'categories': [{'measurements': [{'value': '1.19', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.40', 'spread': '0.2', 'groupId': 'OG002'}]}]}, {'title': 'HDL cholesterol Day 28', 'categories': [{'measurements': [{'value': '1.37', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '1.32', 'spread': '0.2', 'groupId': 'OG002'}]}]}, {'title': 'HDL cholesterol Day 56', 'categories': [{'measurements': [{'value': '1.19', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.30', 'spread': '0.2', 'groupId': 'OG002'}]}]}, {'title': 'Triglycerides Day 0', 'categories': [{'measurements': [{'value': '1.79', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'Triglycerides Day 28', 'categories': [{'measurements': [{'value': '1.73', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'Triglycerides Day 56', 'categories': [{'measurements': [{'value': '1.89', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 28, Day 56', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Acyline + Placebo Gel, Placebo Pill', 'description': 'Acyline 300 µg/kg injections Day 0 \\& 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days'}, {'id': 'FG001', 'title': 'Group 2: Acyline, Testosterone Gel, Placebo Pill', 'description': 'Acyline 300 µg/kg injections Day 0 \\& 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days'}, {'id': 'FG002', 'title': 'Group 3: Acyline, Testosterone Gel, Anastrazole Pill', 'description': 'Acyline 300 μg/kg injections Day 0 \\& 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited using rosters from prior research studies, newspaper and online advertisements. Recruitment began December 2008 and ended March 2010.', 'preAssignmentDetails': 'Before study procedures,2 withdrew consent and 1 was withdrawn by the investigator for missing appointments.4 failed inclusion criteria(1-anemia,1-low testosterone,1-high BMI,1-medications.\n\n31 men enrolled. 22 men completed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Acyline + Placebo Gel, Placebo Pill', 'description': 'Acyline 300 µg/kg injections Day 0 \\& 14 + placebo (no active ingredients) transdermal gel daily for 28 days + oral placebo daily for 28 days'}, {'id': 'BG001', 'title': 'Group 2: Acyline, Testosterone Gel, Placebo Pill', 'description': 'Acyline 300 µg/kg injections Day 0 \\& 14 + Testosterone gel (Testim) 10g 1% daily for 28 days + oral placebo daily for 28 days'}, {'id': 'BG002', 'title': 'Group 3: Acyline, Testosterone Gel, Anastrazole Pill', 'description': 'Acyline 300 μg/kg injections Day 0 \\& 14 + 1% Testosterone gel 10g transdermal daily for 28 days + oral anastrozole 1 mg (Arimidex) daily for 28 days'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '24.3', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '25.8', 'spread': '8.4', 'groupId': 'BG002'}, {'value': '30.0', 'spread': '10.5', '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': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '27.1', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '23.7', 'spread': '2.1', 'groupId': 'BG002'}, {'value': '25.5', 'spread': '3.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-12', 'studyFirstSubmitDate': '2008-08-05', 'resultsFirstSubmitDate': '2011-06-02', 'studyFirstSubmitQcDate': '2008-08-05', 'lastUpdatePostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-12', 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial Progenitor Cells', 'timeFrame': 'Baseline, Day 28', 'description': 'Number of CD33 + CD134+ cells as a percentage of all lymphocytes'}], 'secondaryOutcomes': [{'measure': 'Follicle Stimulating Hormone (FSH)', 'timeFrame': 'Baseline, 28 days'}, {'measure': 'Luteinizing Hormone Concentration (LH)', 'timeFrame': 'Baseline, Day 28'}, {'measure': 'Testosterone Concentration', 'timeFrame': 'Baseline, Day 28'}, {'measure': 'Estradiol Concentration', 'timeFrame': 'Baseline, Day 28'}, {'measure': 'Sex Hormone Binding Globulin (SHBG)', 'timeFrame': 'Baseline, Day 28'}, {'measure': 'Quantitative Insulin Sensitivity Check Index (QUICKI)', 'timeFrame': 'Baseline, Day 28, Day 56', 'description': 'QUICKI is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher QUICKI are associated with decreased insulin resistance and increased insulin sensitivity.'}, {'measure': 'Homeostasis Model of Insulin Resistance (HOMA-IR)', 'timeFrame': 'Baseline, Day 28, Day 56', 'description': 'HOMA IR is a measure of insulin sensitivity calculated using fasting insulin and glucose concentration in a participants blood. Higher HOMA IR numbers are associated with increased insulin resistance and decreased insulin sensitivity.'}, {'measure': 'Fasting Serum Insulin', 'timeFrame': 'Baseline, Day 28, Day 56'}, {'measure': 'Fasting Lipid Levels', 'timeFrame': 'Baseline, Day 28, Day 56'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HDL', 'Insulin sensitivity', 'testosterone', 'estradiol', 'cholesterol'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '15687329', 'type': 'BACKGROUND', 'citation': 'Phillips GB. Is atherosclerotic cardiovascular disease an endocrinological disorder? The estrogen-androgen paradox. J Clin Endocrinol Metab. 2005 May;90(5):2708-11. doi: 10.1210/jc.2004-2011. Epub 2005 Feb 1.'}, {'pmid': '8636300', 'type': 'BACKGROUND', 'citation': 'Bebb RA, Anawalt BD, Christensen RB, Paulsen CA, Bremner WJ, Matsumoto AM. Combined administration of levonorgestrel and testosterone induces more rapid and effective suppression of spermatogenesis than testosterone alone: a promising male contraceptive approach. J Clin Endocrinol Metab. 1996 Feb;81(2):757-62. doi: 10.1210/jcem.81.2.8636300.'}, {'pmid': '12700179', 'type': 'BACKGROUND', 'citation': 'Wu FC, von Eckardstein A. Androgens and coronary artery disease. Endocr Rev. 2003 Apr;24(2):183-217. doi: 10.1210/er.2001-0025.'}, {'pmid': '16983113', 'type': 'BACKGROUND', 'citation': "Keating NL, O'Malley AJ, Smith MR. Diabetes and cardiovascular disease during androgen deprivation therapy for prostate cancer. J Clin Oncol. 2006 Sep 20;24(27):4448-56. doi: 10.1200/JCO.2006.06.2497."}, {'pmid': '15072892', 'type': 'BACKGROUND', 'citation': 'Smith MR. Changes in fat and lean body mass during androgen-deprivation therapy for prostate cancer. Urology. 2004 Apr;63(4):742-5. doi: 10.1016/j.urology.2003.10.063.'}, {'pmid': '11836291', 'type': 'BACKGROUND', 'citation': 'Smith MR, Finkelstein JS, McGovern FJ, Zietman AL, Fallon MA, Schoenfeld DA, Kantoff PW. Changes in body composition during androgen deprivation therapy for prostate cancer. J Clin Endocrinol Metab. 2002 Feb;87(2):599-603. doi: 10.1210/jcem.87.2.8299.'}, {'pmid': '16434464', 'type': 'BACKGROUND', 'citation': 'Smith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. doi: 10.1210/jc.2005-2507. Epub 2006 Jan 24.'}, {'pmid': '16921050', 'type': 'BACKGROUND', 'citation': 'Braga-Basaria M, Dobs AS, Muller DC, Carducci MA, John M, Egan J, Basaria S. Metabolic syndrome in men with prostate cancer undergoing long-term androgen-deprivation therapy. J Clin Oncol. 2006 Aug 20;24(24):3979-83. doi: 10.1200/JCO.2006.05.9741.'}, {'pmid': '16148285', 'type': 'BACKGROUND', 'citation': 'Werner N, Kosiol S, Schiegl T, Ahlers P, Walenta K, Link A, Bohm M, Nickenig G. Circulating endothelial progenitor cells and cardiovascular outcomes. N Engl J Med. 2005 Sep 8;353(10):999-1007. doi: 10.1056/NEJMoa043814.'}, {'pmid': '12829619', 'type': 'BACKGROUND', 'citation': 'Werner N, Junk S, Laufs U, Link A, Walenta K, Bohm M, Nickenig G. Intravenous transfusion of endothelial progenitor cells reduces neointima formation after vascular injury. Circ Res. 2003 Jul 25;93(2):e17-24. doi: 10.1161/01.RES.0000083812.30141.74. Epub 2003 Jun 26.'}, {'pmid': '11440984', 'type': 'BACKGROUND', 'citation': 'Vasa M, Fichtlscherer S, Aicher A, Adler K, Urbich C, Martin H, Zeiher AM, Dimmeler S. Number and migratory activity of circulating endothelial progenitor cells inversely correlate with risk factors for coronary artery disease. Circ Res. 2001 Jul 6;89(1):E1-7. doi: 10.1161/hh1301.093953.'}, {'pmid': '17391216', 'type': 'BACKGROUND', 'citation': 'Dong C, Goldschmidt-Clermont PJ. Endothelial progenitor cells: a promising therapeutic alternative for cardiovascular disease. J Interv Cardiol. 2007 Apr;20(2):93-9. doi: 10.1111/j.1540-8183.2007.00251.x.'}, {'pmid': '16926245', 'type': 'BACKGROUND', 'citation': 'Foresta C, Caretta N, Lana A, De Toni L, Biagioli A, Ferlin A, Garolla A. Reduced number of circulating endothelial progenitor cells in hypogonadal men. J Clin Endocrinol Metab. 2006 Nov;91(11):4599-602. doi: 10.1210/jc.2006-0763. Epub 2006 Aug 22.'}, {'pmid': '17573901', 'type': 'BACKGROUND', 'citation': 'Foresta C, Zuccarello D, Biagioli A, De Toni L, Prana E, Nicoletti V, Ambrosini G, Ferlin A. Oestrogen stimulates endothelial progenitor cells via oestrogen receptor-alpha. Clin Endocrinol (Oxf). 2007 Oct;67(4):520-5. doi: 10.1111/j.1365-2265.2007.02918.x. Epub 2007 Jun 15.'}, {'pmid': '17803706', 'type': 'BACKGROUND', 'citation': 'Foresta C, Zuccarello D, De Toni L, Garolla A, Caretta N, Ferlin A. Androgens stimulate endothelial progenitor cells through an androgen receptor-mediated pathway. Clin Endocrinol (Oxf). 2008 Feb;68(2):284-9. doi: 10.1111/j.1365-2265.2007.03036.x. Epub 2007 Sep 4.'}, {'pmid': '14676142', 'type': 'BACKGROUND', 'citation': 'Iwakura A, Luedemann C, Shastry S, Hanley A, Kearney M, Aikawa R, Isner JM, Asahara T, Losordo DW. Estrogen-mediated, endothelial nitric oxide synthase-dependent mobilization of bone marrow-derived endothelial progenitor cells contributes to reendothelialization after arterial injury. Circulation. 2003 Dec 23;108(25):3115-21. doi: 10.1161/01.CIR.0000106906.56972.83. Epub 2003 Dec 15.'}, {'pmid': '15326314', 'type': 'BACKGROUND', 'citation': "Bergt C, Pennathur S, Fu X, Byun J, O'Brien K, McDonald TO, Singh P, Anantharamaiah GM, Chait A, Brunzell J, Geary RL, Oram JF, Heinecke JW. The myeloperoxidase product hypochlorous acid oxidizes HDL in the human artery wall and impairs ABCA1-dependent cholesterol transport. Proc Natl Acad Sci U S A. 2004 Aug 31;101(35):13032-7. doi: 10.1073/pnas.0405292101. Epub 2004 Aug 23."}, {'pmid': '12519853', 'type': 'BACKGROUND', 'citation': 'Leder BZ, LeBlanc KM, Schoenfeld DA, Eastell R, Finkelstein JS. Differential effects of androgens and estrogens on bone turnover in normal men. J Clin Endocrinol Metab. 2003 Jan;88(1):204-10. doi: 10.1210/jc.2002-021036.'}, {'pmid': '17510436', 'type': 'BACKGROUND', 'citation': 'Mostaghel EA, Page ST, Lin DW, Fazli L, Coleman IM, True LD, Knudsen B, Hess DL, Nelson CC, Matsumoto AM, Bremner WJ, Gleave ME, Nelson PS. Intraprostatic androgens and androgen-regulated gene expression persist after testosterone suppression: therapeutic implications for castration-resistant prostate cancer. Cancer Res. 2007 May 15;67(10):5033-41. doi: 10.1158/0008-5472.CAN-06-3332.'}, {'pmid': '16882745', 'type': 'BACKGROUND', 'citation': 'Page ST, Lin DW, Mostaghel EA, Hess DL, True LD, Amory JK, Nelson PS, Matsumoto AM, Bremner WJ. Persistent intraprostatic androgen concentrations after medical castration in healthy men. J Clin Endocrinol Metab. 2006 Oct;91(10):3850-6. doi: 10.1210/jc.2006-0968. Epub 2006 Aug 1.'}, {'pmid': '16352669', 'type': 'BACKGROUND', 'citation': 'Page ST, Plymate SR, Bremner WJ, Matsumoto AM, Hess DL, Lin DW, Amory JK, Nelson PS, Wu JD. Effect of medical castration on CD4+ CD25+ T cells, CD8+ T cell IFN-gamma expression, and NK cells: a physiological role for testosterone and/or its metabolites. Am J Physiol Endocrinol Metab. 2006 May;290(5):E856-63. doi: 10.1152/ajpendo.00484.2005. Epub 2005 Dec 13.'}, {'pmid': '15579744', 'type': 'BACKGROUND', 'citation': 'Herbst KL, Coviello AD, Page S, Amory JK, Anawalt BD, Bremner WJ. A single dose of the potent gonadotropin-releasing hormone antagonist acyline suppresses gonadotropins and testosterone for 2 weeks in healthy young men. J Clin Endocrinol Metab. 2004 Dec;89(12):5959-65. doi: 10.1210/jc.2003-032123.'}, {'pmid': '14671195', 'type': 'BACKGROUND', 'citation': 'Mauras N, Lima J, Patel D, Rini A, di Salle E, Kwok A, Lippe B. Pharmacokinetics and dose finding of a potent aromatase inhibitor, aromasin (exemestane), in young males. J Clin Endocrinol Metab. 2003 Dec;88(12):5951-6. doi: 10.1210/jc.2003-031279.'}, {'pmid': '17594720', 'type': 'BACKGROUND', 'citation': 'Lin EH, Hassan M, Li Y, Zhao H, Nooka A, Sorenson E, Xie K, Champlin R, Wu X, Li D. Elevated circulating endothelial progenitor marker CD133 messenger RNA levels predict colon cancer recurrence. Cancer. 2007 Aug 1;110(3):534-42. doi: 10.1002/cncr.22774.'}, {'pmid': '12584367', 'type': 'BACKGROUND', 'citation': 'Hill JM, Zalos G, Halcox JP, Schenke WH, Waclawiw MA, Quyyumi AA, Finkel T. Circulating endothelial progenitor cells, vascular function, and cardiovascular risk. N Engl J Med. 2003 Feb 13;348(7):593-600. doi: 10.1056/NEJMoa022287.'}, {'pmid': '12161475', 'type': 'BACKGROUND', 'citation': 'Gonzalo IT, Swerdloff RS, Nelson AL, Clevenger B, Garcia R, Berman N, Wang C. Levonorgestrel implants (Norplant II) for male contraception clinical trials: combination with transdermal and injectable testosterone. J Clin Endocrinol Metab. 2002 Aug;87(8):3562-72. doi: 10.1210/jcem.87.8.8710.'}, {'pmid': '21797916', 'type': 'RESULT', 'citation': 'Rubinow KB, Snyder CN, Amory JK, Hoofnagle AN, Page ST. Acute testosterone deprivation reduces insulin sensitivity in men. Clin Endocrinol (Oxf). 2012 Feb;76(2):281-8. doi: 10.1111/j.1365-2265.2011.04189.x.'}, {'pmid': '22266332', 'type': 'RESULT', 'citation': 'Rubinow KB, Tang C, Hoofnagle AN, Snyder CN, Amory JK, Heinecke JW, Page ST. Acute sex steroid withdrawal increases cholesterol efflux capacity and HDL-associated clusterin in men. Steroids. 2012 Apr;77(5):454-60. doi: 10.1016/j.steroids.2012.01.002. Epub 2012 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'The original purpose of this research study was to understand the effects of testosterone (T) and estrogen on stem cells in the blood. The knowledge would be used to help understand the effects of T and estrogen on cardiovascular (heart and blood vessel) disease, and to help in the development of a safe male hormonal contraceptive.\n\nThe effect of androgens on the number of circulating endothelial progenitor (CEP) cells would best be observed in group 1 (placebo). Upon observation of group 1 under original protocol, changes in CEP cells were not significant but there were changes in markers of inflammation, lipids, and HDL protein composition. A modification to the protocol and title were made to reflect this for groups 2 and 3: Hormonal regulation of HDL-C in Men.', 'detailedDescription': 'We will be administering three drugs: testosterone gel (T), anastrozole, and acyline. We want to see their effects on stem cells and hormone levels in the blood. Acyline suppress luteinizing hormone(LH) and follicle-stimulating hormone(FSH), which are hormones made by the pituitary gland, thus blocking the signal from the brain that causes the testes to make testosterone. Therefore acyline blocks testosterone production. Some men may experience side effects such as hot flashes or irritability from the low levels of T caused by acyline. We are studying whether adding T to acyline will reduce or eliminate these side effects.\n\nSince heart disease is a common problem in men we want to know about the effects of male hormonal contraception on the cardiovascular system. One way to evaluate these risks is to measure the number of progenitor cells and the types of cholesterol in the blood. Progenitor cells are cells that travel in the blood and go to areas of blood vessel injury to help repair the damage amd may help prevent heart attacks and stokes. Some studies suggest that T administration may increase the number of these cells in the blood but other studies have shown that estrogen may be responsible for this effect. In addition, T and estrogen may affect the amount and type of HDL cholesterol in the blood. This is the "good" cholesterol that is thought to protect people from heart attacks and strokes. Therefore, more studies to test the effects of T and estrogen on progenitor cells in the blood and to understand HDL cholesterol in men receiving testosterone are needed.\n\nAcyline is an experimental drug. The FDA allows its use only in research with a small number of volunteers. So far, over 125 men have received acyline. Anastrozole is a drug that blocks the production of estrogen from testosterone. Anastrozole has been given to men safely in the past. Anastrozole is not approved for use in men and is also an experimental drug. Testosterone gel will also be used in this study. It is FDA approved for use in men with low testosterone levels.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males age 18-55 years\n* Normal serum total testosterone (300 ng/dl-1000 ng/dl)\n* Normal LH and FSH levels\n* Taking no regular medications\n* Normal baseline serum hematology, chemistry and liver function tests\n* Agrees not to donate blood during the study\n* Agrees to use a form of contraception during the study\n* Subject must be able to comply with all study procedures\n\nExclusion Criteria:\n\n* Clinically significant screening assessments or other relevant disease, allergy or surgery, as revealed by history, physical examination and/or laboratory assessments, which may limit participation or prevent completion of the study\n* History of prostate cancer, breast cancer, or benign prostatic hypertrophy\n* Prostate-specific antigen (PSA) \\> 3.0\n* History of regular, chronic testosterone or anabolic steroid use in the past year\n* Chronic medical illness, prostate disease, or cardiovascular disease\n* History of a bleeding disorder or need for anticoagulation\n* Skin condition that might interfere with or be exacerbated by T gel use\n* Sitting systolic blood pressure \\> 180mm Hg or \\<90 mm Hg or sitting diastolic blood pressure \\>110 mm Hg or \\< 60 mm Hg.\n* History of clinically significant, untreated sleep apnea\n* Participation in another drug-related research study within the past 2 months\n* Participating in a regular physical relationship with a pregnant woman\n* History of hypersensitivity to any of the study medications (T gel, anastrozole, acyline)\n* History of medical or surgical therapy for benign prostatic hypertrophy\n* Hematocrit \\> 55%\n* History of drug or alcohol abuse within last 6 months\n* Abnormal digital rectal exam at screening'}, 'identificationModule': {'nctId': 'NCT00729859', 'acronym': 'CEP-1', 'briefTitle': 'CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men Title Changed With New Protocol (12/14/09): Hormonal Regulation of HDL-C in Men', 'orgStudyIdInfo': {'id': '33853-A'}, 'secondaryIdInfos': [{'id': 'U54HD042454', 'link': 'https://reporter.nih.gov/quickSearch/U54HD042454', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Acyline 300 µg/kg injections every two weeks (2 doses) + placebo (no active ingredients) gel daily for 28 days + oral placebo pill daily for 28 days', 'interventionNames': ['Drug: Acyline']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Acyline 300 µg/kg injections every two weeks (2 doses) + Testosterone gel 100 mg daily for 28 days + oral placebo pill daily for 28 days', 'interventionNames': ['Drug: Acyline + Testosterone gel']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + oral anastrozole pill 1 mg daily for 28 days', 'interventionNames': ['Drug: Acyline + testosterone gel + anastrozole']}], 'interventions': [{'name': 'Acyline', 'type': 'DRUG', 'otherNames': ['placebo testosterone gel', 'placebo pill'], 'description': 'Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + placebo Testosterone gel daily for 28 days + placebo oral anastrozole pill daily for 28 days', 'armGroupLabels': ['Group 1']}, {'name': 'Acyline + Testosterone gel', 'type': 'DRUG', 'otherNames': ['Acyline', 'testosterone gel'], 'description': 'Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + placebo oral pill 1 mg daily for 28 days', 'armGroupLabels': ['Group 2']}, {'name': 'Acyline + testosterone gel + anastrozole', 'type': 'DRUG', 'otherNames': ['Acyline', 'Testosterone gel', 'Anastrozole'], 'description': 'Acyline 300 μg/kg injections every two weeks (2 doses) for 28 days + Testosterone gel 100 mg daily for 28 days + oral anastrozole pill 1 mg daily for 28 days', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Stephanie Page, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Stephanie T. Page', 'investigatorAffiliation': 'University of Washington'}}}}