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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

July 25, 2011
December 17, 2013
July 2011
September 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01403116 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Male Hypogonadism
  • 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.
  • 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.
  • Experimental: Oral testosterone undecanoate (TU)
    Intervention: Drug: oral testosterone undecanoate
  • Active Comparator: topical testosterone gel
    Intervention: Drug: topical testosterone gel 1%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
325
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Male
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT01403116
CLAR-09007
No
Clarus Therapeutics, Inc.
Clarus Therapeutics, Inc.
  • PharmaNet
  • Los Angeles Biomedical Research Institute
Principal Investigator: Ronald Swerdloff, MD Los Angeles Biomedical Research Institute
Clarus Therapeutics, Inc.
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP