NCT02722278

A Study 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Clarus Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Detailed description

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.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-03-29
• Last updated: 2018-02-23
• Results posted: 2018-02-23

Locations

1 site across 1 country: United States