NCT00695110

Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men

Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Clarus Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.

Detailed description

Determination of the steady-state serum T pharmacokinetic profiles for two oral formulations of T-esters \[testosterone undecanoate (TU) and TU combined with testosterone enanthate (TE)\] administered bis in die (BID) to 29 hypogonadal adult male subjects. TU was evaluated in total daily doses of 400 and 600 mg equivalents of T given twice daily for 7 or 8 days; TU + TE was evaluated in total daily doses of 600 and 800 mg equivalents of T given twice daily for 7 days. All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner. In Treatment Period 3 the effect of food on the study-state pharmacokinetics profile of the TU formulation was evaluated.

Conditions

• Hypogonadism

Interventions

Type	Name	Description
DRUG	Oral testosterone undecanoate (TU) (300 mg T equivalents/dose)	Three capsules each containing 100 mg testosterone (T) as TU, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.
DRUG	Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose)	Two capsules each containing 100 mg T as TU and 100 mg T as TE, BID. 400 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods.
DRUG	Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food)	Two capsules each containing 100 mg T as TU, BID for 8 days. 200 mg T equivalents BID 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods.
DRUG	Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)	Two capsules each containing 150 mg T as TU and 150 mg T as TE, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days.

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-12-01
• Completion: 2009-08-01
• First posted: 2008-06-11
• Last updated: 2021-06-25
• Results posted: 2021-06-24

Locations

4 sites across 1 country: United States