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

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.

Conditions

• Hypogonadism

Interventions

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.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  collaborator OTHER

• Clarus Therapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Ronald S Swerdloff, M.D. · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

• Gregory Flippo, M.D. · Alabama Clinical Therapeutics, Inc.

• Steven J. Kulback, M.D. · Alabama Internal Medicine

• Sherwyn Schwartz, M.D. · dgd Research, Inc.

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

68 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-06-30

Primary Completion

2008-12-31

Completion

2009-08-31

Countries

• United States

Study Locations