Safety and Efficacy Trial of Testosterone Undecanoate

Male Hypogonadism Clinical Trial

Official title:

Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765179
• Other study ID #: CLAR-12011
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2013
• Last updated: November 14, 2017
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: November 2017
• Source: Clarus Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism
• Male Hypogonadism

Intervention

Drug:
• Oral testosterone undecanoate
Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.

Locations

Country	Name	City	State
United States	South Florida Medical Research	Aventura	Florida
United States	Unrologic Consultants of SE Pennsylvania	Bala-Cynwyd	Pennsylvania
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Alabama Internal Medicine, PC	Birmingham	Alabama
United States	PAB Clinical Research	Brandon	Florida
United States	Research Across America	Carrollton	Texas
United States	Innovative Research of West Florida	Clearwater	Florida
United States	Research Across America	Dallas	Texas
United States	SC Clinical Research, Inc.	Garden Grove	California
United States	Precision Trials/Valley Urologic Associates	Glendale	Arizona
United States	Clinical Trial Network	Houston	Texas
United States	Medical Affliated Research Center, Inc.	Huntsville	Alabama
United States	Potenium Clinical Research, LLC	Hurst	Texas
United States	Jacksonville Impotence Treatment Center	Jacksonville	Florida
United States	South ORange County Endocrinology	Laguna Hill	California
United States	Tower Urology, Tower Research Institute	Los Angeles	California
United States	Sunstone Medical Research	Medford	Oregon
United States	Conneticut Clinical Research Center	Middlebury	Connecticut
United States	University Urology Associates	New York	New York
United States	Precision Trials/Valley Urologic Associates	Phoenix	Arizona
United States	Premier Clinical Research Center	Phoenix	Arizona
United States	Rainer Clinical Research Center, Inc.	Renton	Washington
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	San Diego Sexual Medicine	San Diego	California
United States	University of Washington	Seattle	Washington
United States	LABiomedical Research Institute at Harbor-UCLA Medical Center	Torrance	California
United States	Quality of LIfe Medical and Research Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Clarus Therapeutics, Inc.	inVentiv Health Clinical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL	The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.	0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114
Secondary	Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population	The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.	0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114