Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism
ZA-003Ext
An Open-Label, Multiple Center Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Who Completed ZA-003
1 other identifier
interventional
104
1 country
18
Brief Summary
Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.
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
February 10, 2010
CompletedFirst Posted
Study publicly available on registry
February 11, 2010
CompletedJune 27, 2014
June 1, 2014
1.2 years
February 10, 2010
June 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism
One year
Study Arms (2)
12.5 mg Androxal
EXPERIMENTAL12.5 mg Androxal daily
25 mg Androxal
EXPERIMENTAL25 mg Androxal daily
Interventions
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
Medial 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
Commonweatlh 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, MD
Lawrenceville, New Jersey, 08648, United States
Medical 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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2010
First Posted
February 11, 2010
Study Start
March 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
June 27, 2014
Record last verified: 2014-06