Ignite Creation Date:
2025-12-24 @ 11:58 AM
Ignite Modification Date:
2026-01-04 @ 8:54 AM
Study NCT ID:
NCT02432261
Status:
COMPLETED
Last Update Posted:
2025-02-13
First Post:
2015-03-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C029167', 'term': 'ST 1435'}, {'id': 'D013739', 'term': 'Testosterone'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': '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': 'Kimberly.Myer@premier-research.com', 'phone': '9842381297', 'title': 'Kimberly Myer', 'organization': 'Health Decisions'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 10, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 5, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'APPLICATION SITE RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders'}, {'term': 'LOCALIZED INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'EXCORIATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'LIGAMENT SPRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Periorbital contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'SUNBURN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'THERMAL BURN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'HEADACE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'LIBIDO DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Varicocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Gonadotropin Suppression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'difference of proportion of subjects', 'ciNumSides': 'TWO_SIDED', 'paramValue': '57.6', 'estimateComment': 'The difference of proportion = NES/Testosterone - Testosterone', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'We did not statistically power this study.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'To quantify the gonadotropin suppressive activity of 4 weeks daily therapy of a combination transdermal gel containing 8.3 mg Nestorone® (NES) gel and 62.5 mg (1.62%) testosterone (T) gel, and of T gel (1.62%) alone. Specifically, the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone \\[LH\\] and follicle-stimulating hormone \\[FSH\\]) to ≤ 1 IU/L in each group, will be quantified.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gonadotropin and Follicle-stimulating Hormone Suppression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': '• To quantify the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone \\[LH\\] and follicle-stimulating hormone \\[FSH\\]) to the detection limit of the assay in each group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in LH and FSH Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'title': 'LH', 'categories': [{'measurements': [{'value': '-94.55', 'spread': '26.656', 'groupId': 'OG000'}, {'value': '-31', 'spread': '37.638', 'groupId': 'OG001'}]}]}, {'title': 'FSH', 'categories': [{'measurements': [{'value': '-90.25', 'spread': '24.349', 'groupId': 'OG000'}, {'value': '-23.1', 'spread': '33.577', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': '• To quantify the median percent change from baseline to week 4 and interquartile range for serum gonadotropins (LH and FSH) concentrations for each treatment group.', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'categories': [{'title': 'Overall satisfaction: Strongly disagree', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Overall satisfaction: disagree', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Overall satisfaction: undecided', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Overall satisfaction: agree', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Overall satisfaction: Strongly agree', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks', 'description': 'A simple acceptability questionnaire used previously in male CCTN studies was administered at treatment Day 28 (28, 29) for subjects to answer questions about the acceptability of gel as a product and as a method for contraception over the preceding 4 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'T Serum Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'title': 'Testosterone Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '502.9', 'spread': '409.20', 'groupId': 'OG000'}, {'value': '674.9', 'spread': '283.97', 'groupId': 'OG001'}]}]}, {'title': 'Testosterone Day 28: 0 minutes pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '602.1', 'spread': '476.57', 'groupId': 'OG000'}, {'value': '828.1', 'spread': '567.58', 'groupId': 'OG001'}]}]}, {'title': 'Testosterone Day 56 (recovery)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '594.47', 'spread': '217.718', 'groupId': 'OG000'}, {'value': '595.81', 'spread': '205.938', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The difference in numbers means there was missing data'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome # 6 Part 1a: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hemoglobin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.924', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.634', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'General composite safety as measured various times during the study by CBC-Hemoglobin', 'unitOfMeasure': 'g/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'title': 'Sexual Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'spread': '1.483', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.676', 'groupId': 'OG001'}]}]}, {'title': 'Erections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Sexual activity was rated on a scale from 0 (not at all) to 7 (very high enjoyment/pleasure). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory). Results are change from baseline to final treatment evaluation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The difference in numbers means there was missing data in the questionnaire which caused some of the domains to have missing results while some domains could have a score calculated.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'title': 'Total Cholesterol', 'categories': [{'measurements': [{'value': '-5.8', 'spread': '18.21', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '19.10', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides', 'categories': [{'measurements': [{'value': '-12.2', 'spread': '31.16', 'groupId': 'OG000'}, {'value': '-15.8', 'spread': '26.14', 'groupId': 'OG001'}]}]}, {'title': 'HDL', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '7.65', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '5.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline to final treatment evaluation-Total Cholesterol, Triglycerides, HDL', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'title': 'Systolic BP', 'categories': [{'measurements': [{'value': '2.8', 'spread': '6.91', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '8.08', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP', 'categories': [{'measurements': [{'value': '1.8', 'spread': '6.57', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '6.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline to final treatment evaluation', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The difference in numbers means there was missing data.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'title': 'Skin: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin: No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Skin: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Heart: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Heart: No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Heart: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Digital Rectal Exam: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Digital Rectal Exam: No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Digital Rectal Exam: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Change from baseline to final treatment evaluation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The difference in numbers means there was missing data.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'title': 'Sexual Motivation: Change from baseline to final treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '1.765', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.839', 'groupId': 'OG001'}]}]}, {'title': 'Erections: Change from baseline to final treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline to final treatment evaluation. Sexual motivation was rated on a scale of 0 (none) to 7 (very high). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The difference in numbers means there was missing data in the questionnaire which caused some of the domains to have missing results while some domains could have a score calculated.'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome # 6 Part 3: A Composite Safety of the Combined Gel Determined by Outcomes of Patient Health Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'PHQ-9 Total Score: Change from baseline to final treatment evaluation. The Patient Health Questionnaire (PHQ)-9 is a self-administered instrument for screening, monitoring and diagnosis of depression. This questionnaire can be used repeatedly to monitor improvement or worsening of symptoms. Scale range is from 0 (not at all) to 3 (nearly every day).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'NES Serum Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'title': 'Nesterone Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '679.73', 'spread': '716.884', 'groupId': 'OG000'}, {'value': '9.26', 'spread': '34.673', 'groupId': 'OG001'}]}]}, {'title': 'Nesterone Day 28: 0 minutes pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '820.60', 'spread': '706.619', 'groupId': 'OG000'}, {'value': '20.70', 'spread': '49.697', 'groupId': 'OG001'}]}]}, {'title': 'Nesterone Day 56 (recovery)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.03', 'spread': '33.335', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The difference in numbers means there was missing data'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome # 6 Part 1b: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (WBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'categories': [{'measurements': [{'value': '0.182', 'spread': '0.9772', 'groupId': 'OG000'}, {'value': '-0.548', 'spread': '1.0023', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'General composite safety as measured various times during the study by CBC - WBC', 'unitOfMeasure': 'WBCs per microliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome # 6 Part 1c: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hematocrit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'spread': '2.650', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '1.527', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'General composite safety as measured various times during the study by CBC-Hematocrit', 'unitOfMeasure': 'percentage of blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'title': 'ALT', 'categories': [{'measurements': [{'value': '-4.4', 'spread': '7.89', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '7.80', 'groupId': 'OG001'}]}]}, {'title': 'AST', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '9.59', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '15.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline to final treatment evaluation-ALT, AST', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Secondary Outcome # 6 Part 3b: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Weight)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'OG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'classes': [{'categories': [{'measurements': [{'value': '0.045', 'spread': '3.8638', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '3.6888', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Change from baseline to final treatment evaluation', 'unitOfMeasure': 'lbs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The difference in numbers means there was missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'FG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n\nNestorone® /testosterone gel: Nestorone® /testosterone combined gel'}, {'id': 'BG001', 'title': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders\n\nTestosterone only gel: Testosterone only gel'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.7', 'spread': '9.32', 'groupId': 'BG000'}, {'value': '30.7', 'spread': '7.29', 'groupId': 'BG001'}, {'value': '32.7', 'spread': '8.72', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2015-03-19', 'resultsFirstSubmitDate': '2024-04-01', 'studyFirstSubmitQcDate': '2015-04-30', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-12', 'studyFirstPostDateStruct': {'date': '2015-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gonadotropin Suppression', 'timeFrame': '4 weeks', 'description': 'To quantify the gonadotropin suppressive activity of 4 weeks daily therapy of a combination transdermal gel containing 8.3 mg Nestorone® (NES) gel and 62.5 mg (1.62%) testosterone (T) gel, and of T gel (1.62%) alone. Specifically, the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone \\[LH\\] and follicle-stimulating hormone \\[FSH\\]) to ≤ 1 IU/L in each group, will be quantified.'}], 'secondaryOutcomes': [{'measure': 'Gonadotropin and Follicle-stimulating Hormone Suppression', 'timeFrame': '4 weeks', 'description': '• To quantify the proportion (and 95% CI) of men who suppress both gonadotropins (luteinizing hormone \\[LH\\] and follicle-stimulating hormone \\[FSH\\]) to the detection limit of the assay in each group.'}, {'measure': 'Change in LH and FSH Concentrations', 'timeFrame': '4 weeks', 'description': '• To quantify the median percent change from baseline to week 4 and interquartile range for serum gonadotropins (LH and FSH) concentrations for each treatment group.'}, {'measure': 'Acceptability and Satisfaction as Measured by the Contraceptive Gel Acceptability and Satisfaction Questionnaire by Comparing T and NES Serum Concentrations.', 'timeFrame': '4 weeks', 'description': 'A simple acceptability questionnaire used previously in male CCTN studies was administered at treatment Day 28 (28, 29) for subjects to answer questions about the acceptability of gel as a product and as a method for contraception over the preceding 4 weeks.'}, {'measure': 'T Serum Concentrations', 'timeFrame': '8 weeks'}, {'measure': 'Secondary Outcome # 6 Part 1a: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hemoglobin)', 'timeFrame': '4 weeks', 'description': 'General composite safety as measured various times during the study by CBC-Hemoglobin'}, {'measure': 'Assessing Sexual Function by Compare Gonadotropin Suppressive Activity of T and NES Against T Alone Through the Psychosexual Daily Questionnaire.', 'timeFrame': '4 weeks', 'description': 'Sexual activity was rated on a scale from 0 (not at all) to 7 (very high enjoyment/pleasure). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory). Results are change from baseline to final treatment evaluation.'}, {'measure': 'Secondary Outcome # 6 Part 2a: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry', 'timeFrame': '4 weeks', 'description': 'Change from baseline to final treatment evaluation-Total Cholesterol, Triglycerides, HDL'}, {'measure': 'Secondary Outcome # 6 Part 3a: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Blood Pressure)', 'timeFrame': '4 weeks', 'description': 'Change from baseline to final treatment evaluation'}, {'measure': 'Secondary Outcome # 6 Part 4: A Composite Safety of the Combined Gel Determined by Outcomes of Physical Changes', 'timeFrame': '4 weeks', 'description': 'Change from baseline to final treatment evaluation'}, {'measure': 'Secondary Outcome # 6 Part 5: A Composite Safety of the Combined Gel Determined by Outcomes of Psychosexual Questionnaires', 'timeFrame': '4 weeks', 'description': 'Change from baseline to final treatment evaluation. Sexual motivation was rated on a scale of 0 (none) to 7 (very high). Erections were rated on a scale of 0 (not satisfactory) to 7 (very satisfactory).'}, {'measure': 'Secondary Outcome # 6 Part 3: A Composite Safety of the Combined Gel Determined by Outcomes of Patient Health Questionnaires', 'timeFrame': '4 weeks', 'description': 'PHQ-9 Total Score: Change from baseline to final treatment evaluation. The Patient Health Questionnaire (PHQ)-9 is a self-administered instrument for screening, monitoring and diagnosis of depression. This questionnaire can be used repeatedly to monitor improvement or worsening of symptoms. Scale range is from 0 (not at all) to 3 (nearly every day).'}, {'measure': 'NES Serum Concentrations', 'timeFrame': '8 weeks'}, {'measure': 'Secondary Outcome # 6 Part 1b: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (WBC)', 'timeFrame': '4 weeks', 'description': 'General composite safety as measured various times during the study by CBC - WBC'}, {'measure': 'Secondary Outcome # 6 Part 1c: A Composite Safety of the Combined Gel Determined by Outcomes of CBC (Hematocrit)', 'timeFrame': '4 weeks', 'description': 'General composite safety as measured various times during the study by CBC-Hematocrit'}, {'measure': 'Secondary Outcome # 6 Part 2b: A Composite Safety of the Combined Gel Determined by Outcomes of Chemistry', 'timeFrame': '4 weeks', 'description': 'Change from baseline to final treatment evaluation-ALT, AST'}, {'measure': 'Secondary Outcome # 6 Part 3b: A Composite Safety of the Combined Gel Determined by Outcomes of Vitals (Weight)', 'timeFrame': '4 weeks', 'description': 'Change from baseline to final treatment evaluation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['spermatogenesis', 'androgen', 'male contraception'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, double-blinded, two-center trial to evaluate the gonadotropin suppressive activity of transdermal treatment with a combined NES/T gel, or T gel alone, for 28 days.', 'detailedDescription': 'A total of 45 subjects will be enrolled and randomized in a 2:1 ratio to one of two treatment groups. A description of each group is as follows:\n\n* Group 1 (30 subjects): 5.0 mL of the 1.62% combined gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders\n* Group 2 (15 subjects): 4.4 mL of the 1.62% AndrogelTM (containing 62.7 mg T) applied each day to the arms and shoulders\n\nThe total duration of treatment will be 28 days followed by a 72 hour sampling period to assess half-life and a recovery period of at least 28 days, at which point the subjects will return to the clinic for an end of study visit.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening;\n2. 18 to 50 years of age;\n3. BMI \\< 33 calculated as weight in Kg/(height in cm)2;\n4. No history of hormonal therapy use in the last six months prior to the first screening visit;\n5. Subject will agree to use a recognized effective method of contraception with his partner (i.e. at a minimum, condom for the male partner and an effective contraception for the female partner) during the course of the study treatment and recovery phase;\n6. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form;\n7. Does not meet any of the exclusion criteria.\n8. Sperm concentration ≥ 15 million sperm per milliliter ejaculate.\n\nExclusion Criteria:\n\n1. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit;\n2. Men not living in the catchment's area of the clinic or within a reasonable distance from the site;\n3. Clinically significant abnormal physical findings at screening;\n4. Elevated PSA (levels ≥ 4 ng/mL), according to local laboratory normal values;\n5. Abnormal serum chemistry values, according to local laboratory normal values that indicate liver or kidney dysfunction or that may be considered clinically significant;\n6. Use of androgens or body building substances within 6 months before first screening visit;\n7. Diastolic blood pressure (DBP) \\> 80 and/or Systolic (SBP) \\> 130 mm Hg;\n8. EKG abnormal and clinically significant and QTC level longer than 450msec;\n9. History of hypertension, including hypertension controlled with treatment;\n10. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis;\n11. Known hypersensitivity to progestins or androgen;\n12. Family or personal history of venous thromboembolism;\n13. Benign or malignant liver tumors; active liver disease;\n14. Known history of reproductive dysfunction including vasectomy or infertility;\n15. Known history of cardiovascular, renal, hepatic or prostatic disease;\n16. A serious systemic disease such as diabetes mellitus or morbid obesity (body weight greater than 120% of ideal body weight or BMI limitation as above);\n17. Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance;\n18. Known dermatitis or severe skin disorder;\n19. Moderate or severe depression as determined by PHQ-9 score \\>15;\n20. Partner is known to be pregnant;\n21. Known or suspected breast or prostate cancer;\n22. Allergic to any ingredient in testosterone/nestorone gel, including alcohol;\n23. Known history of untreated sleep apnea;\n24. International Prostate Symptom Score (IPSS) greater than or equal to 15."}, 'identificationModule': {'nctId': 'NCT02432261', 'briefTitle': 'Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Men', 'organization': {'class': 'OTHER', 'fullName': 'Premier Research'}, 'officialTitle': 'A Randomized, Two Center, Double-Blind Trial to Evaluate the Pharmacokinetics and Gonadotropin Suppression of Nestorone®-Testosterone (NES/T) Combination Gel in Healthy Men', 'orgStudyIdInfo': {'id': 'CCN005A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': '5.0 mL of the 1.62% Nestorone® /testosterone gel (containing 8.3 mg NES + 62.5 mg T) applied each day on the arms and shoulders', 'interventionNames': ['Drug: Nestorone® /testosterone gel']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': '4.4 mL of the 1.62% Testosterone only gel (AndrogelTM) (containing 62.7 mg T) applied each day to the arms and shoulders', 'interventionNames': ['Drug: Testosterone only gel']}], 'interventions': [{'name': 'Nestorone® /testosterone gel', 'type': 'DRUG', 'description': 'Nestorone® /testosterone combined gel', 'armGroupLabels': ['Group 1']}, {'name': 'Testosterone only gel', 'type': 'DRUG', 'otherNames': ['Androgel'], 'description': 'Testosterone only gel', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'LA Biomedical Research Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Christina Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Site'}, {'name': 'William Bremner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kimberly Myer', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Program Director', 'investigatorFullName': 'Kimberly Myer', 'investigatorAffiliation': 'Premier Research'}}}}