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Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

Primary Purpose

Secondary Hypogonadism

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Androxal
Androxal
AndroGel
Placebo
Sponsored by
Repros Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hypogonadism focused on measuring Secondary Hypogonadism

Eligibility Criteria

18 Years - 68 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Total serum testosterone concentrations < 300 ng/dL at baseline

Exclusion Criteria:

  • Presence or history of prostate cancer
  • Elevated PSA > 3.5 ng/mL

Additional inclusion and exclusion criteria may apply.

Sites / Locations

  • Alabama Clinical Therapeutics, LLC
  • Medical Affiliated Research Center, Inc.
  • Northern California Research Corp.
  • Prime-Care Clinical Research
  • Harbor-UCLA Medical Center
  • Chase Medical Research, LLC
  • Southeastern Research Group, Inc.
  • Northeast Indiana Research, LLC
  • Commonwealth Biomedical Research
  • The Center for Sexual Medicine at Sheppard Pratt
  • Office of Keith Pierce, MD
  • Office of Michael Mall, MD
  • Office of Stephen Miller, MD
  • Advanced Biomedical Research, Inc.
  • Office of Gary S. Karlin
  • Medial Research Associates of Nashville
  • Urology San Antonio Research, PA
  • Salt Lake Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Androxal™ 12.5 mg

Androxal™ 25 mg

AndroGel®

Placebo

Outcomes

Primary Outcome Measures

Evaluate the safety of Androxal™ administered in men with secondary hypogonadism

Secondary Outcome Measures

Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel®

Full Information

First Posted
August 18, 2009
Last Updated
February 10, 2010
Sponsor
Repros Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00962637
Brief Title
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Repros Therapeutics Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Androxal™ 12.5 mg
Arm Title
2
Arm Type
Experimental
Arm Description
Androxal™ 25 mg
Arm Title
3
Arm Type
Active Comparator
Arm Description
AndroGel®
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Androxal
Other Intervention Name(s)
Enclomiphene citrate
Intervention Description
12.5 mg once daily
Intervention Type
Drug
Intervention Name(s)
Androxal
Other Intervention Name(s)
Enclomiphene citrate
Intervention Description
25 mg once daily
Intervention Type
Drug
Intervention Name(s)
AndroGel
Intervention Description
5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule daily
Primary Outcome Measure Information:
Title
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel®
Time Frame
Six months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Total serum testosterone concentrations < 300 ng/dL at baseline Exclusion Criteria: Presence or history of prostate cancer Elevated PSA > 3.5 ng/mL Additional inclusion and exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre van As, MD, PhD
Organizational Affiliation
Repros Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Clinical Therapeutics, LLC
City
Birmingham,
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Northern California Research Corp.
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Prime-Care Clinical Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Southeastern Research Group, Inc.
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Northeast Indiana Research, LLC
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Commonwealth Biomedical Research
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
The Center for Sexual Medicine at Sheppard Pratt
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
Office of Keith Pierce, MD
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
Office of Michael Mall, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Office of Stephen Miller, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Advanced Biomedical Research, Inc.
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Office of Gary S. Karlin
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Medial Research Associates of Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Urology San Antonio Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Salt Lake Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

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Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism

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