Safety and Efficacy Trial of Testosterone Undecanoate

This study has been completed.
Sponsor:
Collaborator:
inVentiv Health Clinical
Information provided by (Responsible Party):
Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01765179
First received: January 8, 2013
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.


Condition Intervention Phase
Male Hypogonadism
Drug: Oral testosterone undecanoate
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of treated patients with an average serum testosterone (T) concentration (Cavg) between 300 and 1000 ng/dL [ Time Frame: Following 114 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of treated patients with maximum serum T concentrations (Cmax) values that are a)less that 1500 ng/dL; b) between 1500 and 1800 ng/dL; c) between 1800 and 2500 ng/dL; and d) greater than 2500 ng/dL. [ Time Frame: Following 114 days of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 144
Study Start Date: January 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral testosterone undecanoate Drug: Oral testosterone undecanoate
Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Serum testosterone of less than or equal to 300 ng/dL (the mean of two samples collected 1 hour apart in the morning between 6:00 and 10:00 AM)

Exclusion Criteria:

  • Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease including hypertension, CHF or CAD, or psychiatric illness including depression.
  • Recent history of stroke, including transient ischemic attack (TIA) or acute coronary event
  • Untreated, severe obstructive sleep apnea
  • Hematocrit <35% or >48%
  • Serum transaminases >2 times upper limit of normal, serum bilirubin >2.0 mg/dL, and serum creatinine >2.0 mg/dL
  • BMI > or equal to 38
  • Stable doses of lipid-lowering medication for less than three months
  • Stable doses of oral medication for diabetes for less than two months
  • Abnormal prostate digital rectal examination [palpable nodule(s)], elevated PSA (serum PSA >3.9 ng/mL), IPSS score > or equal to 19 points, and /or history of prostate cancer.
  • History of breast cancer
  • Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or DHEA with the previous 4 weeks
  • Know malabsorption syndrome and/or current treatment iwht oral lipase inhibitors
  • Known history of abuse of alcohol or any drug substance with the previous 2 years
  • Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or long-acting opioid analgesics
  • Receipt of any drug as part of a research study within 30 days of initial dose administration in this study
  • Blood donation within the 12 week period before initial dose administration in this study
  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: NCT01765179

Locations
United States, Alabama
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
Alabama Internal Medicine, PC
Birmingham, Alabama, United States, 35235
Medical Affliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
United States, Arizona
Precision Trials/Valley Urologic Associates
Glendale, Arizona, United States, 85308
Premier Clinical Research Center
Phoenix, Arizona, United States, 85027
Precision Trials/Valley Urologic Associates
Phoenix, Arizona, United States, 85032
Quality of LIfe Medical and Research Center
Tucson, Arizona, United States, 85712
United States, California
SC Clinical Research, Inc.
Garden Grove, California, United States, 92844
South ORange County Endocrinology
Laguna HIlls, California, United States, 92653
Tower Urology, Tower Research Institute
Los Angeles, California, United States, 90048
San Diego Sexual Medicine
San Diego, California, United States, 92120
LABiomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Connecticut
Conneticut Clinical Research Center
Middlebury, Connecticut, United States, 06762
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
PAB Clinical Research
Brandon, Florida, United States, 33511
Innovative Research of West Florida
Clearwater, Florida, United States, 33756
Jacksonville Impotence Treatment Center
Jacksonville, Florida, United States, 32223
United States, New York
University Urology Associates
New York, New York, United States, 10016
United States, Oregon
Sunstone Medical Research
Medford, Oregon, United States, 97504
United States, Pennsylvania
Unrologic Consultants of SE Pennsylvania
Bala Cynwyd, Pennsylvania, United States, 19004
United States, Texas
Research Across America
Carrolton, Texas, United States, 75010
Research Across America
Dallas, Texas, United States, 75234
Clinical Trial Network
Houston, Texas, United States, 77074
Potenium Clinical Research, LLC
Hurst, Texas, United States, 76053
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
United States, Washington
Rainer Clinical Research Center, Inc.
Renton, Washington, United States, 98057
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Clarus Therapeutics, Inc.
inVentiv Health Clinical
Investigators
Principal Investigator: Ronald Swerdloff, MD Los Andgeles Biomedical Research Institute
  More Information

No publications provided

Responsible Party: Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01765179     History of Changes
Other Study ID Numbers: CLAR-12011
Study First Received: January 8, 2013
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hypogonadism
Eunuchism
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