Clinical trial NCT00695110: Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men
Official title: Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadism
Keywords: testosterone
male hypogonadism
low testosterone
Lead sponsor: Clarus Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
First posted: 2008-06-11
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Male, ages 18-68
* Serum total T less than or equal to 275 ng/dL

Exclusion Criteria:

* Significant intercurrent disease of any type, in particular, liver, kidney or heart disease, uncontrolled diabetes mellitus or psychiatric illness.
* Abnormal prostate digital rectal examination, elevated prostate-specific antigen (PSA), American Urological Association (AUA) symptom score of \>15, and/or history of prostate cancer.
* Hematocrit of \<35 or \>50%
* Body mass index (BMI) \>36
* Serum transaminases \> 2 times upper limit of normal or serum bilirubin \> 2.0 mg/dL

Primary outcomes:
measure: Serum Testosterone Average Concentration (Cavg) (ng/dL)
timeFrame: 30 minutes pre-dose and 0, 1, 2, 4, 8, 12 hours and 0,1, 2, 4, 8, and 12 hours post respective AM/PM doses
measure: Serum Testosterone Area Under Curve (AUC) (0-24) (ng•hr/dL)
timeFrame: 30 minutes pre-dose and 0, 1, 2, 4, 8, 12 hours and 0,1, 2, 4, 8, and 12 hours post respective AM/PM doses
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Birmingham
country: United States
facility: Alabama Internal Medicine
state: Alabama
city: Los Angeles
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
state: California
city: San Antonio
country: United States
facility: dgd Research, Inc.
state: Texas
Study officials:
affiliation: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: Ronald S Swerdloff, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Alabama Clinical Therapeutics, Inc.
name: Gregory Flippo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Alabama Internal Medicine
name: Steven J. Kulback, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: dgd Research, Inc.
name: Sherwyn Schwartz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yin AY, Htun M, Swerdloff RS, Diaz-Arjonilla M, Dudley RE, Faulkner S, Bross R, Leung A, Baravarian S, Hull L, Longstreth JA, Kulback S, Flippo G, Wang C. Reexamination of pharmacokinetics of oral testosterone undecanoate in hypogonadal men with a new self-emulsifying formulation. J Androl. 2012 Mar-Apr;33(2):190-201. doi: 10.2164/jandrol.111.013169. Epub 2011 Apr 7.