NCT02697188

Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Phase IIa, Pilot, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Clarus Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.

Detailed description

Five period cross-over study in which subjects received a single day of dosing in each period. Dosing was either QD or BID with one of two T esters (T-enanthate (TE) or T-undecanoate (TU)). Dosing was within 5 minutes of meals (breakfast and for BID dosing dinner). There was a minimum of a 5-day washout between periods. Subjects were hypogonadal men.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	Testosterone undecanoate	Single-day dose as QD or BID for 3 of 5 crossover periods
DRUG	Testosterone enanthate	Single-day dose for 2 of 5 crossover periods

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2016-03-03
• Last updated: 2018-11-01
• Results posted: 2018-11-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study