Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men - Full Text View

Sponsors and Collaborators:	Clarus Therapeutics, Inc. Los Angeles Biomedical Research Institute
Information provided by:	Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00695110

Purpose

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

Condition	Intervention	Phase
Hypogonadism	Drug: Testosterone undecanoate (TU) Drug: TU + testosterone enanthate (TE)	Phase II

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Further study details as provided by Clarus Therapeutics, Inc.:

Primary Outcome Measures:

Serum testosterone Cmax, Tmax, Cavg and AUC [ Time Frame: 7 day treatment cycles with washouts ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum DHT, E2, TU, and TE pharmacokinetic parameters [ Time Frame: 7 day treatment cycles with washouts ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	June 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Testosterone undecanoate (TU) (300 mg T equivalents) BID for 7 days	Drug: Testosterone undecanoate (TU) 300 mg T equivalents BID for 7 days
2: Experimental TU + testosterone enanthate (TE) (400 mg T equivalents) BID for 7 days	Drug: TU + testosterone enanthate (TE) 400 mg T equivalents BID for 7 days
3: Experimental TU (200 mg T equivalents) BID for 8 days	Drug: Testosterone undecanoate (TU) 200 mg T equivalents BID for 8 days; pharmacokinetics determined when oral TU administered with and without food.
4: Experimental TU + TE (300 mg T equivalents) BID for 7 days	Drug: TU + testosterone enanthate (TE) 300 mg T equivalents BID for 7 days

Eligibility

Ages Eligible for Study:	18 Years to 68 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male, ages 18-68
Serum total testosterone 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 PSA, AUA symptom score of >15, and/or history of prostate cancer.
Hematocrit of <35 or >50%
BMI >36
Serum transaminases > 2 times upper limit of normal or serum bilirubin > 2.0 mg/dL

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695110

Locations

United States, Alabama
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Alabama Internal Medicine
Birmingham, Alabama, United States, 35235
United States, California
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Los Angeles, California, United States, 90502
United States, Texas
dgd Research, Inc.
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Clarus Therapeutics, Inc.

Los Angeles Biomedical Research Institute

Investigators

Principal Investigator:	Ronald S Swerdloff, M.D.	Los Angeles Biomedical Research Institute
Principal Investigator:	Gregory Flippo, M.D.	Alabama Clinical Therapeutics, Inc.
Principal Investigator:	Steven J. Kulback, M.D.	Alabama Internal Medicine
Principal Investigator:	Sherwyn Schwartz, M.D.	dgd Research, Inc.

More Information

Responsible Party:	Clarus Therapeutics, Inc. ( Robert E. Dudley, PhD, President and CEO, Clarus Therapeutics, Inc. )
Study ID Numbers:	CLAR-08005
Study First Received:	June 9, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00695110
Health Authority:	United States: Food and Drug Administration

Keywords provided by Clarus Therapeutics, Inc.:

testosterone
male hypogonadism
low testosterone

Study placed in the following topic categories:

Testosterone
Hypogonadism
Gonadal Disorders
Endocrine System Diseases

Methyltestosterone
Endocrinopathy
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Anabolic Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 16, 2009