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 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:

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate Testosterone undecanoate

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 ]

Secondary Outcome Measures:

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
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 ]


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)
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

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

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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

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 June 29, 2017

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