Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
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
1 other identifier
interventional
194
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2006
Shorter than P25 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 20, 2009
CompletedFebruary 11, 2010
February 1, 2010
1.2 years
August 18, 2009
February 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism
Six months
Secondary Outcomes (1)
Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel®
Six months
Study Arms (4)
1
EXPERIMENTALAndroxal™ 12.5 mg
2
EXPERIMENTALAndroxal™ 25 mg
3
ACTIVE COMPARATORAndroGel®
4
PLACEBO COMPARATORPlacebo
Interventions
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.
Eligibility Criteria
You may qualify if:
- Total serum testosterone concentrations \< 300 ng/dL at baseline
You may not qualify if:
- Presence or history of prostate cancer
- Elevated PSA \> 3.5 ng/mL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801, United States
Northern California Research Corp.
Carmichael, California, 95608, United States
Prime-Care Clinical Research
Mission Viejo, California, 92691, United States
Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Southeastern Research Group, Inc.
Tallahassee, Florida, 32308, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, 46825, United States
Commonwealth Biomedical Research
Madisonville, Kentucky, 42431, United States
The Center for Sexual Medicine at Sheppard Pratt
Baltimore, Maryland, 21285, United States
Office of Keith Pierce, MD
Livonia, Michigan, 48152, United States
Office of Michael Mall, MD
Las Vegas, Nevada, 89109, United States
Office of Stephen Miller, MD
Las Vegas, Nevada, 89144, United States
Advanced Biomedical Research, Inc.
Hackensack, New Jersey, 07601, United States
Office of Gary S. Karlin
Lawrenceville, New Jersey, 08648, United States
Medial Research Associates of Nashville
Nashville, Tennessee, 37203, United States
Urology San Antonio Research, PA
San Antonio, Texas, 78229, United States
Salt Lake Research
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andre van As, MD, PhD
Repros Therapeutics Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 20, 2009
Study Start
March 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
February 11, 2010
Record last verified: 2010-02