Clinical trial NCT01699178: Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men
Official title: Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Male Hypogonadism
Lead sponsor: Clarus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-03
Enrollment: 182
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this one year extension (follow-up) study is to gather additional safety data in hypogonadal men treated with oral TU or AndroGel who have completed the 12-month Phase III study CLAR-09007.

Detailed description: This is the long-term extension of Study CLAR-09007, which like Study CLAR-09007, is an open-label study. This study contained an arm to evaluate the oral TU formulation as well as a comparator arm of the market-leading transdermal T-gel formulation. The comparator arm was included in the Phase III study and in this extension study to allow a general evaluation of comparative safety. Subjects randomized to oral TU in the Phase III study were continued on oral TU in the extension, and those who completed this 12-month Phase IV study have been followed for a total of 2 years of oral TU therapy. Likewise, subjects randomized to transdermal T-gel in the Phase III study were continued on T-gel in the extension, and those who completed this 12-month Phase IV study have been followed for a total of 2 years of T gel therapy. This 2-year period of therapy and assessments was to provide a long-term view of the safety of oral TU and the stability of the T replacement.

Eligibility criteria: Inclusion Criteria:

1. Subjects were to have completed Study CLAR-09007.
2. Subjects were to have adequate venous access in the left or right arm to allow collection of a number of blood samples via a venous cannula.
3. Subjects were required to remain off all forms of T except for study medication throughout the entire study.
4. Subjects voluntarily gave written informed consent to participate in this study.

Subjects meeting any of the following criteria were not eligible for participation in this study:

1. Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease, or psychiatric illness developed during the Phase III study that would, in the opinion of the Investigator, require exclusion from this study.
2. Untreated, severe obstructive sleep apnea (diagnosed during previous Phase III study).
3. Serum transaminases \>2 times upper limit of normal (ULN), serum bilirubin \>2.0 mg/dL and serum creatinine \>2.0 mg/dL at the final visit for Study CLAR 09007.
4. Abnormal prostate digital rectal examination (palpable nodule\[s\]) or elevated PSA (serum PSA \>4 ng/mL) at the final visit for Study CLAR-09007.
5. Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or dehydroepiandrosterone (DHEA).
6. Known malabsorption syndrome and/or current treatment with oral lipase inhibitors (e.g., orlistat \[Xenical\]) and bile acid-binding resins (e.g., cholestyramine \[Questran\], colestipol \[Colestid\]).
7. Poor compliers with study medication, study procedures, or study visits in Study CLAR 09007.
8. Concomitant use of antiandrogens, estrogens, potent oral CYP3A4 inducers (e.g., barbiturates, glucocorticoids \[pharmacologic doses of glucocorticoids for replacement therapy were not exclusionary\]) and potent CYP3A4 inhibitors (e.g., human immunodeficiency virus \[HIV\] antivirals \[indinavir, nelfinavir, ritonavir, saquinavir, delaviridine\], amiodarone, azithromycin, ciprofloxacin, ketoconazole). (Note: Short-term ciprofloxacin administration completed more than 7 days prior to study visits was not exclusionary during the study.)

Primary outcomes:
measure: Absolute Change From Baseline in T Cholesterol
timeFrame: Approximately 365 days
measure: Absolute Change From Baseline in HDL
timeFrame: Approximately 365 days
measure: Absolute Change From Baseline in LDL
timeFrame: Approximately 365 days
measure: Absolute Change From Baseline in Hgb
timeFrame: Approximately 365 days
measure: Absolute Change From Baseline in Hct
timeFrame: Approximately 365 days
measure: Absolute Change From Baseline in Prostate Volume
timeFrame: Approximately 365 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, Inc.
state: Alabama
city: Birmingham
country: United States
facility: Alabama Internal Medicine, PC
state: Alabama
city: Calera
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc
state: Alabama
city: Tucson
country: United States
facility: Quality of Life Medical and Research Centers, LLC
state: Arizona
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Laguna Hills
country: United States
facility: South Orange County Endocrinology
state: California
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine, UCLA
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center, LA Biomedical Research Institute
state: California
city: Middlebury
country: United States
facility: Connecticut Clinical Research Center/ConnecTrials
state: Connecticut
city: New Haven
country: United States
facility: University of CT School of Medicine
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Great Neck
country: United States
facility: Bruce R. Gilbert, MD, PhD
state: New York
city: New York
country: United States
facility: University Urology Associates
state: New York
city: Purchase
country: United States
facility: Michael A. Werner
state: New York
city: Medford
country: United States
facility: Sunstone Medical Research
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southeast 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: Seattle
country: United States
facility: University of Washington
state: Washington
city: Bonn
country: Germany
facility: University of Bonn, Clinic for Dermatology and Allergy
city: Halle
country: Germany
facility: University of Halle, Center for Reproduction and Andrology
city: Leipzig
country: Germany
facility: Praxis Dr. Szymula
city: Markkleeberg
country: Germany
facility: Praxis Dr. Schulze
city: Muenster
country: Germany
facility: University of Muenster, Center for Reproduction and Andrology
Study officials:
affiliation: University of California, Los Angeles
name: Ronald Swerdloff, MD
role: PRINCIPAL_INVESTIGATOR
References: