A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men (inTUne)
|Hypogonadism||Drug: Oral Testosterone Undecanoate Drug: Axiron Testosterone Topical Solution||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Basic Science
|Official Title:||A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men|
- The proportion of oral TU treated subjects who have a total T Cavg in the eugonadal range of 300 to 1000 ng/dL at Visit 7 [ Time Frame: Day 105 ]
- The proportion of oral TU treated subjects who have a total T Cmax ≤ 1500 ng/dL, > 1800 ng/dL and ≤ 2500 ng/dL, and > 2500 ng/dL [ Time Frame: Day 105 ]
|Actual Study Start Date:||March 2016|
|Study Completion Date:||November 2016|
|Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: Oral Testosterone Undecanoate
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).
Drug: Oral 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.
Other Name: Oral TU
Active Comparator: Axiron Testosterone Topical Solution
Subjects randomly assigned to the Axiron treatment group will begin treatment at a dose of 60 mg every morning.
Drug: Axiron Testosterone Topical Solution
Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.
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.
Other Name: Axiron solution
This is a multicenter, Phase 3, randomized, open-label, active-comparator group, efficacy (based on Cavg of T), and safety study in adult hypogonadal male subjects. Enrollment is based on criteria designed to select the general population of hypogonadal men. Study drug doses will be titrated using a dose-titration algorithm based on total T Cavg. Subjects may be androgen treatment-naïve or washed out of prior androgen replacement therapies.
Subjects must have 2 total T levels < 300 ng/dL based on 2 blood samples obtained in the morning (AM) on 2 separate days approximately 7 days apart.
Approximately 180 subjects will be randomly assigned to receive open-label treatment in a 3:1 ratio of oral TU to Axiron (ie, approximately 135 subjects will be randomly assigned to oral TU and approximately 45 subjects will be randomly assigned to Axiron topical solution). Subjects who complete the study will receive 105 days of treatment. Serial pharmacokinetics (PK) samples over 24 hours will be obtained after 21, 56 and 105 days of treatment. Dose titrations will be based on the T Cavg on day 21 and 56 of treatment.
A subset of 30 subjects will participate in a cosyntropin stimulation test. Subjects will receive an injection of cosyntropin on Day 1 (before administration of study drug) and Day 106 after the last 24-hour PK sample has been drawn. Cortisol assay will be collected immediately before the injection, as well as 30 and 60 minutes after the injection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02722278
|United States, Illinois|
|Multiple Sites in the United States|
|Northbrook, Illinois, United States, 60062|
|Principal Investigator:||Ronald Swerdloff, MD||Primary Principal Investigator|