Open-label, Follow-up Study of Oral Testosterone Undecanoate in Hypogonadal Men

Male Hypogonadism Clinical Trial

Official title:

Open-Label Study of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01699178
• Other study ID #: CLAR-12010
• Status: Completed
• Phase: Phase 3
• Start date: August 2012
• Est. completion date: April 2014

Study information

• Verified date: June 2021
• Source: Clarus Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Hypogonadism
• Male Hypogonadism

Intervention

Drug:
• Oral testosterone undecanoate
Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID
• Transdermal testosterone gel (AndroGel)
Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD

Locations

Country	Name	City	State
Germany	University of Bonn, Clinic for Dermatology and Allergy	Bonn
Germany	University of Halle, Center for Reproduction and Andrology	Halle
Germany	Praxis Dr. Szymula	Leipzig
Germany	Praxis Dr. Schulze	Markkleeberg
Germany	University of Muenster, Center for Reproduction and Andrology	Muenster
United States	South Florida Medical Research	Aventura	Florida
United States	Urologic Consultants of Southeast Pennsylvania	Bala-Cynwyd	Pennsylvania
United States	Johns Hopkins University	Baltimore	Maryland
United States	Alabama Clinical Therapeutics, Inc.	Birmingham	Alabama
United States	Alabama Internal Medicine, PC	Birmingham	Alabama
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Maimonides Medical Center	Brooklyn	New York
United States	Providence Clinical Research	Burbank	California
United States	Alabama Clinical Therapeutics	Calera	Alabama
United States	Research Across America	Carrollton	Texas
United States	Research Across America	Dallas	Texas
United States	Bruce R. Gilbert, MD, PhD	Great Neck	New York
United States	Medical Affiliated Research Center, Inc	Huntsville	Alabama
United States	South Orange County Endocrinology	Laguna Hills	California
United States	David Geffen School of Medicine, UCLA	Los Angeles	California
United States	Tower Urology	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Sunstone Medical Research	Medford	Oregon
United States	Connecticut Clinical Research Center/ConnecTrials	Middlebury	Connecticut
United States	University of CT School of Medicine	New Haven	Connecticut
United States	University Urology Associates	New York	New York
United States	Michael A. Werner	Purchase	New York
United States	University of Washington	Seattle	Washington
United States	Harbor-UCLA Medical Center, LA Biomedical Research Institute	Torrance	California
United States	Quality of Life Medical and Research Centers, LLC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Clarus Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in T Cholesterol	Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.	Approximately 365 days
Primary	Absolute Change From Baseline in HDL	Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.	Approximately 365 days
Primary	Absolute Change From Baseline in LDL	Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.	Approximately 365 days
Primary	Absolute Change From Baseline in Hgb	Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.	Approximately 365 days
Primary	Absolute Change From Baseline in Hct	Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.	Approximately 365 days
Primary	Absolute Change From Baseline in Prostate Volume	Long-term safety profile of oral TU product compared with AndroGel based on absolute change from primary baseline based on Total Cholesterol, HDL, LDL, hemoglobin, hematocrit and prostate volume.	Approximately 365 days