Clinical trial NCT01765179: Safety and Efficacy Trial of Testosterone Undecanoate
Official title: Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Male Hypogonadism
Keywords: testosterone
male hypogonadism
low testosterone
Lead sponsor: Clarus Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: inVentiv Health Clinical
First posted: 2013-01-10
Enrollment: 144
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL
timeFrame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114
Secondary outcomes:
measure: Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population
timeFrame: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Birmingham
country: United States
facility: Alabama Internal Medicine, PC
state: Alabama
city: Huntsville
country: United States
facility: Medical Affliated Research Center, Inc.
state: Alabama
city: Glendale
country: United States
facility: Precision Trials/Valley Urologic Associates
state: Arizona
city: Phoenix
country: United States
facility: Premier Clinical Research Center
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials/Valley Urologic Associates
state: Arizona
city: Tucson
country: United States
facility: Quality of LIfe Medical and Research Center
state: Arizona
city: Garden Grove
country: United States
facility: SC Clinical Research, Inc.
state: California
city: Laguna Hill
country: United States
facility: South ORange County Endocrinology
state: California
city: Los Angeles
country: United States
facility: Tower Urology, Tower Research Institute
state: California
city: San Diego
country: United States
facility: San Diego Sexual Medicine
state: California
city: Torrance
country: United States
facility: LABiomedical Research Institute at Harbor-UCLA Medical Center
state: California
city: Middlebury
country: United States
facility: Conneticut Clinical Research Center
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Impotence Treatment Center
state: Florida
city: New York
country: United States
facility: University Urology Associates
state: New York
city: Medford
country: United States
facility: Sunstone Medical Research
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Unrologic Consultants of SE Pennsylvania
state: Pennsylvania
city: Carrollton
country: United States
facility: Research Across America
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Hurst
country: United States
facility: Potenium Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Renton
country: United States
facility: Rainer Clinical Research Center, Inc.
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Los Andgeles Biomedical Research Institute
name: Ronald Swerdloff, MD
role: PRINCIPAL_INVESTIGATOR
References: