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

This study has been completed.
Sponsor:
Collaborator:
Los Angeles Biomedical Research Institute
Information provided by:
Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00695110
First received: June 9, 2008
Last updated: August 23, 2010
Last verified: August 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II, Repeat Dose, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Serum testosterone Cmax [ Time Frame: 7 day treatment cycles with washouts ] [ Designated as safety issue: Yes ]
  • Serum testosterone Cavg [ Time Frame: 7 day treatment cycles with washouts ] [ Designated as safety issue: Yes ]
  • Serum testosterone Tmax [ Time Frame: 7 day treatment cycles with washouts ] [ Designated as safety issue: No ]
  • Serum testosterone AUC [ Time Frame: 7 day treatment cycles with washouts ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum DHT Cmax [ Time Frame: 7 day treatment cycles with washouts ] [ Designated as safety issue: No ]
  • Serum DHT Cavg [ Time Frame: 7 day treatment cycles with washouts ] [ Designated as safety issue: No ]
  • Serum DHT Tmax [ Time Frame: 7 day treatment cycles with washout ] [ Designated as safety issue: No ]
  • Serum DHT AUC [ Time Frame: 7 day treatment cycles with washouts ] [ Designated as safety issue: No ]
  • Mean serum estradiol [ Time Frame: 7 day treatment cycles with washout ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: June 2008
Study Completion Date: August 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Testosterone undecanoate (TU) (300 mg T equivalents) BID for 7 days
Drug: Testosterone undecanoate (TU)
300 mg T equivalents BID for 7 days
Experimental: 2
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
Experimental: 3
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.
Experimental: 4
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Clarus Therapeutics, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert E. Dudley, PhD, President and CEO, Clarus Therapeutics, Inc., Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00695110     History of Changes
Other Study ID Numbers: CLAR-08005
Study First Received: June 9, 2008
Last Updated: August 23, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Clarus Therapeutics, Inc.:
testosterone
male hypogonadism
low testosterone

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on September 22, 2014