NCT02722278 - A Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men | Biotech Hunter

Enrollment

222

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

November 30, 2016

Study Completion Date

November 30, 2016

Conditions

Hypogonadism

Interventions

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.

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."

Trial Locations (1)

60062

Multiple Sites in the United States, Northbrook