Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-26 @ 5:52 PM
Study NCT ID:
NCT01327495
Status:
COMPLETED
Last Update Posted:
2017-10-05
First Post:
2011-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D005782', 'term': 'Gels'}, {'id': 'C109238', 'term': 'acyline'}, {'id': 'C092464', 'term': 'LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-'}], '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'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'page@uw.edu', 'phone': '206-616-0483', 'title': 'Stephanie Page, MD, PhD', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded from day 1 through the end of study, Week 18. After the screening period, 12 weeks of treatment commenced for subjects who met inclusion/exclusion criteria, followed by a 6 week recovery period.', 'description': 'The 62 subjects who started study drugs on Day 0 were monitored for adverse events. Nine subjects were discontinued prior to study end. Two subjects were not included in data analysis due to medication non-compliance. Hence, while there were 51 subjects included in the analysis, 62 subjects (all who started study drugs) were monitored for adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks\n\nplacebo acyline: Placebo acyline subcutaneous injection every 2 weeks\n\nplacebo gel: daily placebo testosterone gel applied transdermally x 12 weeks', 'otherNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks\n\nTestosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks', 'otherNumAtRisk': 11, 'otherNumAffected': 8, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Arm 3', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks\n\nTestosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks', 'otherNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Arm 4', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks\n\nTestosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks', 'otherNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Arm 5', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks\n\ntestosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks', 'otherNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Arm 6', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks\n\ntestosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks', 'otherNumAtRisk': 11, 'otherNumAffected': 6, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abnormal liver funtion tests', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction to Acyline', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort at injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flashes/night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mood changes (irritability)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased libido', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased libido', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased energy, fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Semen changes (decreased ejaculation volume', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin changes (acne, rash at site of T gel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nipple discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sexually transmitted disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea, vomiting, abnormal bowl movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory infection/symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injuries/accidents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood in semen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruise at injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prostate Tissue DHT Concentrations After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel', 'description': 'Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \\& daily placebo testosterone (T) gel applied transdermally for 12 weeks.'}, {'id': 'OG001', 'title': 'Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.'}, {'id': 'OG002', 'title': 'Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.'}, {'id': 'OG003', 'title': 'Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.'}, {'id': 'OG004', 'title': 'Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.'}, {'id': 'OG005', 'title': 'Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.05', 'groupId': 'OG000', 'lowerLimit': '3.75', 'upperLimit': '4.62'}, {'value': '4.26', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '5.57'}, {'value': '2.99', 'groupId': 'OG002', 'lowerLimit': '2.57', 'upperLimit': '3.79'}, {'value': '3.88', 'groupId': 'OG003', 'lowerLimit': '3.61', 'upperLimit': '4.476'}, {'value': '4.12', 'groupId': 'OG004', 'lowerLimit': '2.04', 'upperLimit': '6.30'}, {'value': '5.11', 'groupId': 'OG005', 'lowerLimit': '4.4', 'upperLimit': '8.69'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'To measure intraprostatic dihydrotestosterone \\[DHT\\] levels', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Serum Testosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel', 'description': 'Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \\& daily placebo testosterone (T) gel applied transdermally for 12 weeks.'}, {'id': 'OG001', 'title': 'Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.'}, {'id': 'OG002', 'title': 'Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.'}, {'id': 'OG003', 'title': 'Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.'}, {'id': 'OG004', 'title': 'Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.'}, {'id': 'OG005', 'title': 'Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '5.0'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '3.8'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '4.4'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '2.9', 'upperLimit': '6.4'}, {'value': '6.1', 'groupId': 'OG004', 'lowerLimit': '2.7', 'upperLimit': '9.9'}, {'value': '7.7', 'groupId': 'OG005', 'lowerLimit': '5.3', 'upperLimit': '10.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dihydrotestosterone (DHT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel', 'description': 'Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \\& daily placebo testosterone (T) gel applied transdermally for 12 weeks.'}, {'id': 'OG001', 'title': 'Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.'}, {'id': 'OG002', 'title': 'Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.'}, {'id': 'OG003', 'title': 'Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.'}, {'id': 'OG004', 'title': 'Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.'}, {'id': 'OG005', 'title': 'Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.5'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.7'}, {'value': '0.9', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '1.2'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '1.2'}, {'value': '1.5', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '2.5'}, {'value': '1.8', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '3.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prostate Tissue Testosterone Concentrations After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1/Placebo Acyline Inject & Placebo Testosterone Gel', 'description': 'Placebo acyline subcutaneous injection every 2 weeks for 12 weeks \\& daily placebo testosterone (T) gel applied transdermally for 12 weeks.'}, {'id': 'OG001', 'title': 'Arm 2 Acyline Inject Every 2 Weeks & Daily T 1% Gel 1.25g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 1.25g applied transdermally for 12 weeks.'}, {'id': 'OG002', 'title': 'Arm 3 Acyline Inject Every 2 Weeks & Daily T 1% Gel 2.5', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 2.5g applied transdermally for 12 weeks.'}, {'id': 'OG003', 'title': 'Acyline Inject Every 2 Weeks & Daily T 1% Gel 5g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 5g applied transdermally for 12 weeks.'}, {'id': 'OG004', 'title': 'Acyline Inject Every 2 Weeks & Daily T 1% Gel 10g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 10g applied transdermally for 12 weeks.'}, {'id': 'OG005', 'title': 'Acyline Inject Every 2 Weeks & Daily T 1% Gel 15g', 'description': 'Acyline (300ug/kg) subcutaneous injection every 2 weeks for 12 weeks \\& daily 1% testosterone (T) gel 15g applied transdermally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.2275', 'upperLimit': '0.535'}, {'value': '0.13', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.24'}, {'value': '0.125', 'groupId': 'OG002', 'lowerLimit': '0.1075', 'upperLimit': '0.165'}, {'value': '0.18', 'groupId': 'OG003', 'lowerLimit': '0.15', 'upperLimit': '0.35'}, {'value': '0.195', 'groupId': 'OG004', 'lowerLimit': '0.1275', 'upperLimit': '0.77'}, {'value': '0.3', 'groupId': 'OG005', 'lowerLimit': '0.22', 'upperLimit': '1.72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'To measure intraprostatic testosterone levels', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prostate Specific Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks\n\nplacebo acyline: Placebo acyline subcutaneous injection every 2 weeks\n\nplacebo gel: daily placebo testosterone gel applied transdermally x 12 weeks'}, {'id': 'OG001', 'title': 'Arm 2', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks\n\nTestosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG002', 'title': 'Arm 3', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks\n\nTestosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG003', 'title': 'Arm 4', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks\n\nTestosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG004', 'title': 'Arm 5', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks\n\ntestosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG005', 'title': 'Arm 6', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks\n\ntestosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '0.97'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.44', 'upperLimit': '0.62'}, {'value': '0.61', 'groupId': 'OG002', 'lowerLimit': '0.39', 'upperLimit': '0.81'}, {'value': '0.58', 'groupId': 'OG003', 'lowerLimit': '0.41', 'upperLimit': '0.78'}, {'value': '0.52', 'groupId': 'OG004', 'lowerLimit': '0.43', 'upperLimit': '0.67'}, {'value': '0.76', 'groupId': 'OG005', 'lowerLimit': '0.50', 'upperLimit': '1.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Prostate Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks\n\nplacebo acyline: Placebo acyline subcutaneous injection every 2 weeks\n\nplacebo gel: daily placebo testosterone gel applied transdermally x 12 weeks'}, {'id': 'OG001', 'title': 'Arm 2', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks\n\nTestosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG002', 'title': 'Arm 3', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks\n\nTestosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG003', 'title': 'Arm 4', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks\n\nTestosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG004', 'title': 'Arm 5', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks\n\ntestosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG005', 'title': 'Arm 6', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks\n\ntestosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '22'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '22'}, {'value': '19', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '21'}, {'value': '15', 'groupId': 'OG003', 'lowerLimit': '14', 'upperLimit': '17'}, {'value': '16', 'groupId': 'OG004', 'lowerLimit': '15', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG005', 'lowerLimit': '16', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'International Prostate Symptom Score (IPSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks\n\nplacebo acyline: Placebo acyline subcutaneous injection every 2 weeks\n\nplacebo gel: daily placebo testosterone gel applied transdermally x 12 weeks'}, {'id': 'OG001', 'title': 'Arm 2', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks\n\nTestosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG002', 'title': 'Arm 3', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks\n\nTestosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG003', 'title': 'Arm 4', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks\n\nTestosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG004', 'title': 'Arm 5', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks\n\ntestosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG005', 'title': 'Arm 6', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks\n\ntestosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '5.25'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '2.5', 'groupId': 'OG004', 'lowerLimit': '1.5', 'upperLimit': '7.75'}, {'value': '4', 'groupId': 'OG005', 'lowerLimit': '1', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'description': 'IPSS score: 0-7 mildly symptomatic, 8-19 moderately symptomatic, 20-35 severely symptomatic', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '17-OHPreg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks\n\nplacebo acyline: Placebo acyline subcutaneous injection every 2 weeks\n\nplacebo gel: daily placebo testosterone gel applied transdermally x 12 weeks'}, {'id': 'OG001', 'title': 'Arm 2', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks\n\nTestosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG002', 'title': 'Arm 3', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks\n\nTestosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG003', 'title': 'Arm 4', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks\n\nTestosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG004', 'title': 'Arm 5', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks\n\ntestosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG005', 'title': 'Arm 6', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks\n\ntestosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.19', 'groupId': 'OG000', 'lowerLimit': '1.06', 'upperLimit': '1.44'}, {'value': '1.25', 'groupId': 'OG001', 'lowerLimit': '0.93', 'upperLimit': '2.07'}, {'value': '1.23', 'groupId': 'OG002', 'lowerLimit': '0.92', 'upperLimit': '2.04'}, {'value': '1.05', 'groupId': 'OG003', 'lowerLimit': '1.01', 'upperLimit': '1.89'}, {'value': '1.02', 'groupId': 'OG004', 'lowerLimit': '0.94', 'upperLimit': '1.45'}, {'value': '1.36', 'groupId': 'OG005', 'lowerLimit': '1.29', 'upperLimit': '1.47'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '17-OHP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks\n\nplacebo acyline: Placebo acyline subcutaneous injection every 2 weeks\n\nplacebo gel: daily placebo testosterone gel applied transdermally x 12 weeks'}, {'id': 'OG001', 'title': 'Arm 2', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks\n\nTestosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG002', 'title': 'Arm 3', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks\n\nTestosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG003', 'title': 'Arm 4', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks\n\nTestosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG004', 'title': 'Arm 5', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks\n\ntestosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG005', 'title': 'Arm 6', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks\n\ntestosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.06'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.05', 'upperLimit': '0.06'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.04', 'upperLimit': '0.05'}, {'value': '0.05', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.05'}, {'value': '0.05', 'groupId': 'OG004', 'lowerLimit': '0.04', 'upperLimit': '0.05'}, {'value': '0.05', 'groupId': 'OG005', 'lowerLimit': '0.04', 'upperLimit': '0.07'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Androstenedione', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks\n\nplacebo acyline: Placebo acyline subcutaneous injection every 2 weeks\n\nplacebo gel: daily placebo testosterone gel applied transdermally x 12 weeks'}, {'id': 'OG001', 'title': 'Arm 2', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks\n\nTestosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG002', 'title': 'Arm 3', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks\n\nTestosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG003', 'title': 'Arm 4', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks\n\nTestosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG004', 'title': 'Arm 5', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks\n\ntestosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG005', 'title': 'Arm 6', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks\n\ntestosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.33'}, {'value': '0.11', 'groupId': 'OG001', 'lowerLimit': '0.10', 'upperLimit': '0.18'}, {'value': '0.12', 'groupId': 'OG002', 'lowerLimit': '0.09', 'upperLimit': '0.15'}, {'value': '0.13', 'groupId': 'OG003', 'lowerLimit': '0.12', 'upperLimit': '0.15'}, {'value': '0.18', 'groupId': 'OG004', 'lowerLimit': '0.15', 'upperLimit': '0.28'}, {'value': '0.14', 'groupId': 'OG005', 'lowerLimit': '0.12', 'upperLimit': '0.22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Androsterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks\n\nplacebo acyline: Placebo acyline subcutaneous injection every 2 weeks\n\nplacebo gel: daily placebo testosterone gel applied transdermally x 12 weeks'}, {'id': 'OG001', 'title': 'Arm 2', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks\n\nTestosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG002', 'title': 'Arm 3', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks\n\nTestosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG003', 'title': 'Arm 4', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks\n\nTestosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG004', 'title': 'Arm 5', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks\n\ntestosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG005', 'title': 'Arm 6', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks\n\ntestosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '0.21'}, {'value': '0.15', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '0.22'}, {'value': '0.12', 'groupId': 'OG002', 'lowerLimit': '0.08', 'upperLimit': '0.14'}, {'value': '0.17', 'groupId': 'OG003', 'lowerLimit': '0.11', 'upperLimit': '0.24'}, {'value': '0.17', 'groupId': 'OG004', 'lowerLimit': '0.12', 'upperLimit': '0.43'}, {'value': '0.21', 'groupId': 'OG005', 'lowerLimit': '0.17', 'upperLimit': '0.23'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'DHEA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks\n\nplacebo acyline: Placebo acyline subcutaneous injection every 2 weeks\n\nplacebo gel: daily placebo testosterone gel applied transdermally x 12 weeks'}, {'id': 'OG001', 'title': 'Arm 2', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks\n\nTestosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG002', 'title': 'Arm 3', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks\n\nTestosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG003', 'title': 'Arm 4', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks\n\nTestosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG004', 'title': 'Arm 5', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks\n\ntestosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG005', 'title': 'Arm 6', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks\n\ntestosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000', 'lowerLimit': '19.1', 'upperLimit': '42.0'}, {'value': '26.2', 'groupId': 'OG001', 'lowerLimit': '13.5', 'upperLimit': '35.8'}, {'value': '22.1', 'groupId': 'OG002', 'lowerLimit': '16.2', 'upperLimit': '30.1'}, {'value': '26.8', 'groupId': 'OG003', 'lowerLimit': '26.0', 'upperLimit': '29.2'}, {'value': '24.4', 'groupId': 'OG004', 'lowerLimit': '23.0', 'upperLimit': '28.2'}, {'value': '18.6', 'groupId': 'OG005', 'lowerLimit': '14.7', 'upperLimit': '22.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pregnenolone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks\n\nplacebo acyline: Placebo acyline subcutaneous injection every 2 weeks\n\nplacebo gel: daily placebo testosterone gel applied transdermally x 12 weeks'}, {'id': 'OG001', 'title': 'Arm 2', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks\n\nTestosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG002', 'title': 'Arm 3', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks\n\nTestosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG003', 'title': 'Arm 4', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks\n\nTestosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG004', 'title': 'Arm 5', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks\n\ntestosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG005', 'title': 'Arm 6', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks\n\ntestosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000', 'lowerLimit': '23.6', 'upperLimit': '33.8'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '36.4'}, {'value': '32.7', 'groupId': 'OG002', 'lowerLimit': '23.3', 'upperLimit': '51.2'}, {'value': '32.4', 'groupId': 'OG003', 'lowerLimit': '28.6', 'upperLimit': '45.5'}, {'value': '27.9', 'groupId': 'OG004', 'lowerLimit': '17.4', 'upperLimit': '37.6'}, {'value': '23.9', 'groupId': 'OG005', 'lowerLimit': '18.1', 'upperLimit': '25.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Progesterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks\n\nplacebo acyline: Placebo acyline subcutaneous injection every 2 weeks\n\nplacebo gel: daily placebo testosterone gel applied transdermally x 12 weeks'}, {'id': 'OG001', 'title': 'Arm 2', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks\n\nTestosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG002', 'title': 'Arm 3', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks\n\nTestosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG003', 'title': 'Arm 4', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks\n\nTestosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG004', 'title': 'Arm 5', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks\n\ntestosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'OG005', 'title': 'Arm 6', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks\n\ntestosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.20'}, {'value': '0.08', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '0.09'}, {'value': '0.06', 'groupId': 'OG002', 'lowerLimit': '0.04', 'upperLimit': '0.09'}, {'value': '0.08', 'groupId': 'OG003', 'lowerLimit': '0.07', 'upperLimit': '0.13'}, {'value': '0.09', 'groupId': 'OG004', 'lowerLimit': '0.08', 'upperLimit': '0.12'}, {'value': '0.07', 'groupId': 'OG005', 'lowerLimit': '0.07', 'upperLimit': '0.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'ng/g', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1 (Placebo Acyline & Placebo T Gel )', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks\n\nplacebo acyline: Placebo acyline subcutaneous injection every 2 weeks\n\nplacebo gel: daily placebo testosterone gel applied transdermally x 12 weeks'}, {'id': 'FG001', 'title': 'Arm 2 (Acyline & 1.25g Testosterone Gel)', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks\n\nTestosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'FG002', 'title': 'Arm 3 (Acyline & 2.5g Testosterone Gel)', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks\n\nTestosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'FG003', 'title': 'Arm 4 (Acyline & 5g Testosterone Gel)', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks\n\nTestosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'FG004', 'title': 'Arm 5 (Acyline & 10g Testosterone Gel)', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks\n\ntestosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'FG005', 'title': 'Arm 6 (Acyline & 15g Testosterone Gel)', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks\n\ntestosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '1 dropped due to decreased libido \\& energy, 1 dropped due to too much pain with acyline injections', 'groupId': 'FG000', 'numSubjects': '8'}, {'comment': '1 subject declined prostate biopsy \\& no-showed to final visit, 1 subject dropped d/t elevated LFTs.', 'groupId': 'FG001', 'numSubjects': '9'}, {'comment': '1 withdrawn due to injection AE. 1 drop-out (declined prostate biopsy and final visit).', 'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'comment': '1 dropped out pre drug finish, 2 non-compliant subjects dropped', 'groupId': 'FG004', 'numSubjects': '8'}, {'comment': '1 subject withdrawn d/t elevated LFTs, 1 dropped out d/t ski accident', 'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy males, 25-55 years old, were recruited via advertisement: flyers and newspaper ads at the University of Washington.', 'preAssignmentDetails': '98 screened. 28 screen fails (or did not finish screen). 8 subjects dropped out prior to drug start. 62 subjects started drug. 7 subjects dropped after drug start/pre-drug finish. 2 dropped after finishing study drug, but prior to prostate biopsy. 2 subjects dropped from analysis for non-compliance. 51 completed entire study, included in analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks\n\nplacebo acyline: Placebo acyline subcutaneous injection every 2 weeks\n\nplacebo gel: daily placebo testosterone gel applied transdermally x 12 weeks'}, {'id': 'BG001', 'title': 'Arm 2', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks\n\nTestosterone 1% gel 1.25 g: testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'BG002', 'title': 'Arm 3', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks\n\nTestosterone 1% gel 2.5 g: Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'BG003', 'title': 'Arm 4', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks\n\nTestosterone 1% gel 5.0 g: Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'BG004', 'title': 'Arm 5', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks\n\ntestosterone 1% gel 10 g: Testosterone 1% gel 10 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'BG005', 'title': 'Arm 6', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks\n\ntestosterone 1% gel 15 g: Testosterone 1% gel 15 g daily applied transdermally x 12 weeks\n\nAcyline: 300 ug/kg subcutaneous injection every 2 weeks'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '48'}, {'value': '45', 'groupId': 'BG001', 'lowerLimit': '41', 'upperLimit': '46'}, {'value': '46', 'groupId': 'BG002', 'lowerLimit': '39', 'upperLimit': '51'}, {'value': '34', 'groupId': 'BG003', 'lowerLimit': '30', 'upperLimit': '44'}, {'value': '42', 'groupId': 'BG004', 'lowerLimit': '33', 'upperLimit': '47'}, {'value': '51', 'groupId': 'BG005', 'lowerLimit': '50', 'upperLimit': '54'}, {'value': '44', 'groupId': 'BG006', 'lowerLimit': '35', 'upperLimit': '50'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '51', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '33'}, {'value': '28', 'groupId': 'BG001', 'lowerLimit': '25', 'upperLimit': '33'}, {'value': '26', 'groupId': 'BG002', 'lowerLimit': '24', 'upperLimit': '28'}, {'value': '25', 'groupId': 'BG003', 'lowerLimit': '25', 'upperLimit': '27'}, {'value': '25', 'groupId': 'BG004', 'lowerLimit': '22', 'upperLimit': '28'}, {'value': '26', 'groupId': 'BG005', 'lowerLimit': '25', 'upperLimit': '28'}, {'value': '26', 'groupId': 'BG006', 'lowerLimit': '25', 'upperLimit': '29'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg^m2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Testosterone Level', 'classes': [{'categories': [{'measurements': [{'value': '450', 'groupId': 'BG000', 'lowerLimit': '315', 'upperLimit': '516'}, {'value': '448', 'groupId': 'BG001', 'lowerLimit': '345', 'upperLimit': '509'}, {'value': '554', 'groupId': 'BG002', 'lowerLimit': '462', 'upperLimit': '730'}, {'value': '419', 'groupId': 'BG003', 'lowerLimit': '387', 'upperLimit': '505'}, {'value': '482', 'groupId': 'BG004', 'lowerLimit': '429', 'upperLimit': '591'}, {'value': '452', 'groupId': 'BG005', 'lowerLimit': '396', 'upperLimit': '536'}, {'value': '459', 'groupId': 'BG006', 'lowerLimit': '390', 'upperLimit': '530'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'DHT Level', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '47'}, {'value': '37', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '44'}, {'value': '43', 'groupId': 'BG002', 'lowerLimit': '39', 'upperLimit': '59'}, {'value': '39', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '49'}, {'value': '49', 'groupId': 'BG004', 'lowerLimit': '44', 'upperLimit': '55'}, {'value': '36', 'groupId': 'BG005', 'lowerLimit': '28', 'upperLimit': '53'}, {'value': '40', 'groupId': 'BG006', 'lowerLimit': '28', 'upperLimit': '52'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Lutenizing Hormone', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '4.5'}, {'value': '5', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '6'}, {'value': '4', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '5.5'}, {'value': '3', 'groupId': 'BG003', 'lowerLimit': '3', 'upperLimit': '4'}, {'value': '4', 'groupId': 'BG004', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '3', 'groupId': 'BG005', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '4', 'groupId': 'BG006', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'FSH', 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '8.5'}, {'value': '4', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '5', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '5', 'groupId': 'BG003', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '5.5', 'groupId': 'BG004', 'lowerLimit': '5', 'upperLimit': '7'}, {'value': '7', 'groupId': 'BG005', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '5', 'groupId': 'BG006', 'lowerLimit': '4', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Hematocrit', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '45'}, {'value': '43', 'groupId': 'BG001', 'lowerLimit': '41', 'upperLimit': '44'}, {'value': '43', 'groupId': 'BG002', 'lowerLimit': '42', 'upperLimit': '44'}, {'value': '44', 'groupId': 'BG003', 'lowerLimit': '41', 'upperLimit': '46'}, {'value': '45', 'groupId': 'BG004', 'lowerLimit': '42', 'upperLimit': '45'}, {'value': '43', 'groupId': 'BG005', 'lowerLimit': '41', 'upperLimit': '44'}, {'value': '43', 'groupId': 'BG006', 'lowerLimit': '41', 'upperLimit': '45'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': '%', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Prostate Specific Antigen (PSA)', 'classes': [{'categories': [{'measurements': [{'value': '0.80', 'groupId': 'BG000', 'lowerLimit': '0.61', 'upperLimit': '0.91'}, {'value': '0.71', 'groupId': 'BG001', 'lowerLimit': '0.66', 'upperLimit': '0.88'}, {'value': '1.09', 'groupId': 'BG002', 'lowerLimit': '0.75', 'upperLimit': '1.25'}, {'value': '0.74', 'groupId': 'BG003', 'lowerLimit': '0.34', 'upperLimit': '0.86'}, {'value': '0.67', 'groupId': 'BG004', 'lowerLimit': '0.41', 'upperLimit': '0.91'}, {'value': '0.69', 'groupId': 'BG005', 'lowerLimit': '0.35', 'upperLimit': '0.91'}, {'value': '0.75', 'groupId': 'BG006', 'lowerLimit': '0.42', 'upperLimit': '0.96'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Prostate volume', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '22'}, {'value': '19', 'groupId': 'BG001', 'lowerLimit': '13', 'upperLimit': '23'}, {'value': '17', 'groupId': 'BG002', 'lowerLimit': '17', 'upperLimit': '21'}, {'value': '17', 'groupId': 'BG003', 'lowerLimit': '14', 'upperLimit': '18'}, {'value': '17', 'groupId': 'BG004', 'lowerLimit': '14', 'upperLimit': '20'}, {'value': '19', 'groupId': 'BG005', 'lowerLimit': '15', 'upperLimit': '19'}, {'value': '18', 'groupId': 'BG006', 'lowerLimit': '14', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm^3', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'International Prostate Symptom Score (IPSS)', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'BG000', 'lowerLimit': '1.5', 'upperLimit': '3'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4.25'}, {'value': '0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '1.5', 'groupId': 'BG004', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG005', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG006', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'description': '0-7 mildly symptomatic, 8-19 moderately symptomatic, 20-35 severely symptomatic', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': '62 subjects started treatment, 11 dropped after drug start \\& pre-study exit visit (7 dropped post-drug start but pre-drug finish, 2 dropped after drug finish but pre-prostate biopsy, 2 dropped for non-compliance). 51 participants included in the analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-07', 'studyFirstSubmitDate': '2011-03-21', 'resultsFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2011-03-31', 'lastUpdatePostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-07', 'studyFirstPostDateStruct': {'date': '2011-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '17-OHPreg', 'timeFrame': '12 weeks'}, {'measure': '17-OHP', 'timeFrame': '12 weeks'}, {'measure': 'Androstenedione', 'timeFrame': '12 weeks'}, {'measure': 'Androsterone', 'timeFrame': '12 weeks'}, {'measure': 'DHEA', 'timeFrame': '12 weeks'}, {'measure': 'Pregnenolone', 'timeFrame': '12 weeks'}, {'measure': 'Progesterone', 'timeFrame': '12 weeks'}], 'primaryOutcomes': [{'measure': 'Prostate Tissue DHT Concentrations After Treatment', 'timeFrame': '12 weeks', 'description': 'To measure intraprostatic dihydrotestosterone \\[DHT\\] levels'}, {'measure': 'Serum Testosterone', 'timeFrame': '12 weeks'}, {'measure': 'Dihydrotestosterone (DHT)', 'timeFrame': '12 weeks'}, {'measure': 'Prostate Tissue Testosterone Concentrations After Treatment', 'timeFrame': '12 weeks', 'description': 'To measure intraprostatic testosterone levels'}], 'secondaryOutcomes': [{'measure': 'Prostate Specific Antigen', 'timeFrame': '12 weeks'}, {'measure': 'Prostate Volume', 'timeFrame': '12 weeks'}, {'measure': 'International Prostate Symptom Score (IPSS)', 'timeFrame': '12 weeks', 'description': 'IPSS score: 0-7 mildly symptomatic, 8-19 moderately symptomatic, 20-35 severely symptomatic'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Androgen replacement in men'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '27172434', 'type': 'RESULT', 'citation': 'Thirumalai A, Cooper LA, Rubinow KB, Amory JK, Lin DW, Wright JL, Marck BT, Matsumoto AM, Page ST. Stable Intraprostatic Dihydrotestosterone in Healthy Medically Castrate Men Treated With Exogenous Testosterone. J Clin Endocrinol Metab. 2016 Jul;101(7):2937-44. doi: 10.1210/jc.2016-1483. Epub 2016 May 12.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will conduct a three-month, randomized, placebo-controlled trial comparing the effects of increasing doses of androgen supplementation with Testosterone (T) gel on the prostate in healthy men who are treated with acyline to block gonadal androgen production.', 'detailedDescription': 'The investigators overall goals are (i) to determine the relationship between serum and prostate tissue hormone concentrations in men in response to increasing doses of exogenous androgens; (ii) to determine the impact that alterations in serum and tissue testosterone concentrations have on prostate epithelial cell function and phenotype; and (iii) to determine the relationships between prostatic androgens and alterations in the tissue microenvironment. The investigators will perform a study in healthy, middle-aged men to address the following Specific Aims:\n\nSpecific Aims: To compare the dose-response relationships between serum testosterone and intraprostatic androgens and androgen action, and serum testosterone and anabolic activity in healthy, middle-aged men.\n\nHypothesis: The investigators hypothesize that very low levels of serum testosterone will lower concentrations of intraprostatic testosterone and dihydrotestosterone (DHT). However, when serum testosterone concentrations are within or even above the normal range there will be no significant increases in intraprostatic testosterone and dihydrotestosterone. In contrast, the investigators expect that anabolic activity will increase with increasing concentrations of circulating testosterone.\n\nSecondarily, the investigators hypothesize that increasing levels of serum testosterone beyond the low normal range will have little impact on androgen action within the prostate.\n\nApproach: The investigators will conduct a randomized, placebo-controlled trial in healthy men who are medically castrated and administered one of five different doses of testosterone gel (Androgel) for 12 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIn good health, without severe systemic illness (i.e., renal, liver, cardiac or lung disease, cancer, insulin dependent diabetes)\n\n* Male between the ages of 25 and 55 years old\n* Able to understand and comply with protocol instructions and requirements\n* International Prostate Symptom Score (IPSS) \\<11\n* Agrees to not donate blood during the study\n* Normal serum total T, LH, FSH, urine analysis, COMP, CBC and sperm count\n\nExclusion Criteria:\n\n* History of, or current breast cancer or prostate cancer\n* Clinically significant findings on digital rectal exam such as nodules, areas of induration or any other malignancy or abnormal prostate ultrasound\n* History of invasive therapy for BPH\n* Current or past treatment with a 5α-reductase inhibitor\n* History of drug or alcohol abuse within the past 12 months\n* History of a bleeding disorder or anticoagulation\n* Skin disease that might interfere with T-gel absorption\n* Participation in another drug study in the past 3 months\n* A first-degree relative (i.e. father, brother) with a history of prostate cancer\n* History of infertility or desire for fertility within 6 months, or current pregnant female partner\n* Weight \\>320 pounds or BMI \\> 40\n* PSA Level \\> 2.1'}, 'identificationModule': {'nctId': 'NCT01327495', 'acronym': 'PROS-2', 'briefTitle': 'PROS-2 Dose Response Effects of Exogenous Testosterone on the Prostate', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Dose Response Effects of Exogenous Testosterone on the Prostate and Comparison With Effects on Body Composition (Short Title: PROS-2)', 'orgStudyIdInfo': {'id': '39738'}, 'secondaryIdInfos': [{'id': '1R01AG037603-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01AG037603-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 1: Placebo', 'description': 'Placebo acyline every 2 weeks for two weeks + daily placebo gel x 12 weeks', 'interventionNames': ['Other: placebo acyline', 'Other: placebo gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2:1.25g Testosterone', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 1.25 g daily x 12 weeks', 'interventionNames': ['Drug: Testosterone 1% gel 1.25 g', 'Drug: Acyline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3: 2.5g Testosterone', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 2.5 g daily x 12 weeks', 'interventionNames': ['Drug: Testosterone 1% gel 2.5 g', 'Drug: Acyline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 4: 5g Testosterone', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 5.0 g daily x 12 weeks', 'interventionNames': ['Drug: Testosterone 1% gel 5.0 g', 'Drug: Acyline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 5: 10g Testosterone', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 10 g daily x 12 weeks', 'interventionNames': ['Drug: testosterone 1% gel 10 g', 'Drug: Acyline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 6: 15g Testosterone', 'description': 'Acyline (300µg/kg every two weeks) + testosterone 1% gel 15 g daily x 12 weeks', 'interventionNames': ['Drug: testosterone 1% gel 15 g', 'Drug: Acyline']}], 'interventions': [{'name': 'placebo acyline', 'type': 'OTHER', 'otherNames': ['placebo'], 'description': 'Placebo acyline subcutaneous injection every 2 weeks', 'armGroupLabels': ['Arm 1: Placebo']}, {'name': 'placebo gel', 'type': 'OTHER', 'otherNames': ['placebo'], 'description': 'daily placebo testosterone gel applied transdermally x 12 weeks', 'armGroupLabels': ['Arm 1: Placebo']}, {'name': 'Testosterone 1% gel 1.25 g', 'type': 'DRUG', 'otherNames': ['Androgel'], 'description': 'testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks', 'armGroupLabels': ['Arm 2:1.25g Testosterone']}, {'name': 'Testosterone 1% gel 2.5 g', 'type': 'DRUG', 'otherNames': ['Androgel'], 'description': 'Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks', 'armGroupLabels': ['Arm 3: 2.5g Testosterone']}, {'name': 'Testosterone 1% gel 5.0 g', 'type': 'DRUG', 'otherNames': ['Androgel'], 'description': 'Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks', 'armGroupLabels': ['Arm 4: 5g Testosterone']}, {'name': 'testosterone 1% gel 10 g', 'type': 'DRUG', 'otherNames': ['Androgel'], 'description': 'Testosterone 1% gel 10 g daily applied transdermally x 12 weeks', 'armGroupLabels': ['Arm 5: 10g Testosterone']}, {'name': 'testosterone 1% gel 15 g', 'type': 'DRUG', 'otherNames': ['Androgel'], 'description': 'Testosterone 1% gel 15 g daily applied transdermally x 12 weeks', 'armGroupLabels': ['Arm 6: 15g Testosterone']}, {'name': 'Acyline', 'type': 'DRUG', 'otherNames': ['GNRH antagonist'], 'description': '300 ug/kg subcutaneous injection every 2 weeks', 'armGroupLabels': ['Arm 2:1.25g Testosterone', 'Arm 3: 2.5g Testosterone', 'Arm 4: 5g Testosterone', 'Arm 5: 10g Testosterone', 'Arm 6: 15g Testosterone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Stephanie T Page, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Department of Medicine, Division of Metabolism, Endocrinology and Nutrition', 'investigatorFullName': 'Stephanie T. Page', 'investigatorAffiliation': 'University of Washington'}}}}