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

NCT ID: NCT01699178

Last Updated: 2021-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-04-30

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.

Conditions

Male Hypogonadism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral testosterone undecanoate

Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months.

Group Type: EXPERIMENTAL

Oral testosterone undecanoate

Intervention Type: DRUG

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)

Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months

Group Type: ACTIVE_COMPARATOR

Transdermal testosterone gel (AndroGel)

Intervention Type: DRUG

Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD

Interventions

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

Intervention Type: DRUG

Transdermal testosterone gel (AndroGel)

Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD

Intervention Type: DRUG

Other Intervention Names

Oral TU; AndroGel

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Clarus Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Swerdloff, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Alabama Clinical Therapeutics, Inc.

Birmingham, Alabama, United States

Alabama Internal Medicine, PC

Birmingham, Alabama, United States

Alabama Clinical Therapeutics

Calera, Alabama, United States

Medical Affiliated Research Center, Inc

Huntsville, Alabama, United States

Quality of Life Medical and Research Centers, LLC

Tucson, Arizona, United States

Providence Clinical Research

Burbank, California, United States

South Orange County Endocrinology

Laguna Hills, California, United States

Tower Urology

Los Angeles, California, United States

David Geffen School of Medicine, UCLA

Los Angeles, California, United States

Harbor-UCLA Medical Center, LA Biomedical Research Institute

Torrance, California, United States

Connecticut Clinical Research Center/ConnecTrials

Middlebury, Connecticut, United States

University of CT School of Medicine

New Haven, Connecticut, United States

South Florida Medical Research

Aventura, Florida, United States

University of Louisville

Louisville, Kentucky, United States

Johns Hopkins University

Baltimore, Maryland, United States

Boston University School of Medicine

Boston, Massachusetts, United States

Maimonides Medical Center

Brooklyn, New York, United States

Bruce R. Gilbert, MD, PhD

Great Neck, New York, United States

University Urology Associates

New York, New York, United States

Michael A. Werner

Purchase, New York, United States

Sunstone Medical Research

Medford, Oregon, United States

Urologic Consultants of Southeast Pennsylvania

Bala-Cynwyd, Pennsylvania, United States

Research Across America

Carrollton, Texas, United States

Research Across America

Dallas, Texas, United States

University of Washington

Seattle, Washington, United States

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

Münster, , Germany

Countries

United States; Germany

References

Honig S, Gittelman M, Kaminetsky J, Wang C, Amory JK, Rohowsky N, Dudley RE, Woun Seo B, Newmark J, Swerdloff R. Two-Year Analysis of a New Oral Testosterone Undecanoate (TU) Formulation in Hypogonadal Men: Efficacy, Impact on Psychosexual Function, and Safety. J Sex Med. 2022 Dec;19(12):1750-1758. doi: 10.1016/j.jsxm.2022.09.002. Epub 2022 Oct 20.

Reference Type: DERIVED

PMID: 36272969 (View on PubMed)

Other Identifiers

CLAR-12010

Identifier Type: -

Identifier Source: org_study_id