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

Primary Purpose

Male Hypogonadism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oral testosterone undecanoate
Transdermal testosterone gel (AndroGel)
Sponsored by
Clarus Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Hypogonadism

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.)

Sites / Locations

  • Alabama Clinical Therapeutics, Inc.
  • Alabama Internal Medicine, PC
  • Alabama Clinical Therapeutics
  • Medical Affiliated Research Center, Inc
  • Quality of Life Medical and Research Centers, LLC
  • Providence Clinical Research
  • South Orange County Endocrinology
  • Tower Urology
  • David Geffen School of Medicine, UCLA
  • Harbor-UCLA Medical Center, LA Biomedical Research Institute
  • Connecticut Clinical Research Center/ConnecTrials
  • University of CT School of Medicine
  • South Florida Medical Research
  • University of Louisville
  • Johns Hopkins University
  • Boston University School of Medicine
  • Maimonides Medical Center
  • Bruce R. Gilbert, MD, PhD
  • University Urology Associates
  • Michael A. Werner
  • Sunstone Medical Research
  • Urologic Consultants of Southeast Pennsylvania
  • Research Across America
  • Research Across America
  • University of Washington
  • University of Bonn, Clinic for Dermatology and Allergy
  • University of Halle, Center for Reproduction and Andrology
  • Praxis Dr. Szymula
  • Praxis Dr. Schulze
  • University of Muenster, Center for Reproduction and Andrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral testosterone undecanoate

Transdermal testosterone gel (AndroGel)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 5, 2012
Last Updated
June 25, 2021
Sponsor
Clarus Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01699178
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clarus Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral testosterone undecanoate
Arm Type
Experimental
Arm Description
Oral testosterone undecanoate; continue dose from previous Phase III trial; 100-300 mg T (as TU), BID, for 12 months.
Arm Title
Transdermal testosterone gel (AndroGel)
Arm Type
Active Comparator
Arm Description
Transdermal testosterone gel; continue dose from previous Phase III trial, 2.5-10 g/applied once daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Oral testosterone undecanoate
Other Intervention Name(s)
Oral TU
Intervention Description
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
Intervention Name(s)
Transdermal testosterone gel (AndroGel)
Other Intervention Name(s)
AndroGel
Intervention Description
Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in T Cholesterol
Description
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.
Time Frame
Approximately 365 days
Title
Absolute Change From Baseline in HDL
Description
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.
Time Frame
Approximately 365 days
Title
Absolute Change From Baseline in LDL
Description
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.
Time Frame
Approximately 365 days
Title
Absolute Change From Baseline in Hgb
Description
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.
Time Frame
Approximately 365 days
Title
Absolute Change From Baseline in Hct
Description
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.
Time Frame
Approximately 365 days
Title
Absolute Change From Baseline in Prostate Volume
Description
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.
Time Frame
Approximately 365 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects were to have completed Study CLAR-09007. 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. Subjects were required to remain off all forms of T except for study medication throughout the entire study. 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: 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. Untreated, severe obstructive sleep apnea (diagnosed during previous Phase III study). 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. Abnormal prostate digital rectal examination (palpable nodule[s]) or elevated PSA (serum PSA >4 ng/mL) at the final visit for Study CLAR-09007. 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). 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]). Poor compliers with study medication, study procedures, or study visits in Study CLAR 09007. 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Swerdloff, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alabama Clinical Therapeutics, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Alabama Internal Medicine, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Alabama Clinical Therapeutics
City
Calera
State/Province
Alabama
ZIP/Postal Code
35040
Country
United States
Facility Name
Medical Affiliated Research Center, Inc
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Quality of Life Medical and Research Centers, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
South Orange County Endocrinology
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Tower Urology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
David Geffen School of Medicine, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Harbor-UCLA Medical Center, LA Biomedical Research Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Connecticut Clinical Research Center/ConnecTrials
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
University of CT School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Bruce R. Gilbert, MD, PhD
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
University Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Michael A. Werner
City
Purchase
State/Province
New York
ZIP/Postal Code
10577
Country
United States
Facility Name
Sunstone Medical Research
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Urologic Consultants of Southeast Pennsylvania
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Research Across America
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Bonn, Clinic for Dermatology and Allergy
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
University of Halle, Center for Reproduction and Andrology
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Praxis Dr. Szymula
City
Leipzig
ZIP/Postal Code
04105
Country
Germany
Facility Name
Praxis Dr. Schulze
City
Markkleeberg
ZIP/Postal Code
04416
Country
Germany
Facility Name
University of Muenster, Center for Reproduction and Andrology
City
Muenster
ZIP/Postal Code
48149
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant data shared with associated investigational sites only.

Learn more about this trial

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

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