{"denoms":[{"counts":[{"groupId":"BG000","value":"166"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"222"}],"units":"Participants"}],"groups":[{"description":"Approximately 135 subjects will receive oral TU treatment during the study for approximately 3.5 months. Subjects randomly assigned to the oral TU treatment group will begin treatment at a dose of 237 mg TU twice daily (BID).\n\nOral Testosterone Undecanoate: Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \\< 350 ng/dL, decreased if \\> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.","id":"BG000","title":"Oral Testosterone Undecanoate"},{"description":"Subjects randomly assigned to the Axiron treatment group will begin treatment at a dose of 60 mg every morning.\n\nAxiron Testosterone Topical Solution: Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.\n\nSerial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg \\< 350 ng/dL, decreased if \\> 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.","id":"BG001","title":"Axiron Testosterone Topical Solution"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"160"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"214"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"8"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"9.08","value":"51.6"},{"groupId":"BG001","spread":"7.86","value":"53.4"},{"groupId":"BG002","spread":"8.81","value":"52"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"166"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"222"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"40"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"141"},{"groupId":"BG001","value":"41"},{"groupId":"BG002","value":"182"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"40"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"133"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"175"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"166"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"222"}]}],"title":"United States"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Region of Enrollment","unitOfMeasure":"Participants"}]}