NCT00911586

Pharmacokinetic Study to Determine Time to Steady-state

Pharmacokinetic Study to Determine Time to Steady-state of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Clarus Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.

Detailed description

Serum testosterone levels will be obtained in hypogonadal (serum testosterone \<300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.

Conditions

• Male Hypogonadism
• Primary Hypogonadism
• Secondary Hypogonadism

Interventions

Type	Name	Description
DRUG	Testosterone undecanoate

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-09-01
• Completion: 2010-01-01
• First posted: 2009-06-02
• Last updated: 2020-12-11
• Results posted: 2020-12-11

Locations

1 site across 1 country: United States