Hypogonadism Clinical Trial
Official title:
A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
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 approximately 105 days of treatment. Dose
titrations will be based on the T Cavg from serial PK sampling obtained on day 21 and 56 of
treatment. Primary efficacy will be based on percentage of subjects within eugonadal range at
Visit 7.
A subset of approximately 30 subjects will participate in a cosyntropin stimulation test on
Day 1 (before administration of study drug) and Day 106 after the last 24-hour PK sample has
been drawn.
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