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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Male Hypogonadism	Drug: oral testosterone undecanoate; Drug: topical testosterone gel 1%	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	325 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Study Start Date :	July 2011
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	September 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Comparison of change from baseline in safety parameters between treatment groups. [ Time Frame: 365 days ]
   • 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
2. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Clarus Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT01403116 History of Changes
Other Study ID Numbers:	CLAR-09007
First Posted:	July 27, 2011
Last Update Posted:	December 18, 2013
Last Verified:	December 2013

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