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Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

This study has been completed.
Sponsor:
Collaborators:
PharmaNet
Los Angeles Biomedical Research Institute
Information provided by (Responsible Party):
Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01403116
First received: July 25, 2011
Last updated: December 17, 2013
Last verified: December 2013
History of Changes
  Purpose
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.

Condition Intervention Phase
Male Hypogonadism
 Drug: oral testosterone undecanoate
Drug: topical testosterone gel 1%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Percentage of oral TU treated patients with average serum testosterone (T)concentrations (Cavg) between 300 and 1000 ng/dL. [ Time Frame: Following 90 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of change from baseline in safety parameters between treatment groups. [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]
    • Number of subjects with adverse events during treatment of one year
    • Change from baseline in safety laboratory parameters (i.e., clinical chemistry, hematology, cardiovascular biomarkers, PSA) for up to one year
    • Change from baseline in prostate volume for up to one year

  • Percentage of treated patients with maximum serum T concentrations (Cmax) values that are (a) less than 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: 90 days ] [ Designated as safety issue: Yes ]
Enrollment: 325
Study Start Date: July 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oral testosterone undecanoate (TU) Drug: oral testosterone undecanoate
Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
Active Comparator: topical testosterone gel Drug: topical testosterone gel 1%
Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Serum testosterone of less than or equal to 300 ng/dL on two occasions within one week (may wash out from previous oral, topical or buccal testosterone therapy)

Exclusion Criteria:

  • Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness
  • Recent history of stroke, not including transient ischemic attack
  • Untreated, sever 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 mgk/dL
  • BMI > or equal to 36
  • Stable doses of lipid-lowering medication for less than 3 months
  • Stable doses of oral medication for diabetes for less than 2 months
  • Abnormal prostate DRE [palpable nodule(s)], elevated PSA (>4 ng/mL), IPSS score > or equal to 19 points.
  • History of breast cancer
  • Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum testosterone within previous 4 weeks
  • Known malabsorption syndrome and/or current treatment with oral lipase inhibitors
  • History of abuse of alcohol or any drug substance within 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 the initial study dose.
  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: NCT01403116

  Show 30 Study Locations
Sponsors and Collaborators
Clarus Therapeutics, Inc.
PharmaNet
Los Angeles Biomedical Research Institute
Investigators
Principal Investigator: Ronald Swerdloff, MD Los Angeles Biomedical Research Institute
  More Information

Responsible Party: Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01403116     History of Changes
Other Study ID Numbers: CLAR-09007 
Study First Received: July 25, 2011
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
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents

ClinicalTrials.gov processed this record on September 27, 2016