Clinical trial NCT01067365: Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism
Official title: An Open-Label, Multiple Center Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Who Completed ZA-003
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hypogonadism
Keywords: Secondary Hypogonadism
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-11
Enrollment: 104
Sex: MALE
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.

Detailed description: The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003.

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.

Primary outcomes:
measure: Evaluate the safety of Androxal™ administered in men with secondary hypogonadism
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham,
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Huntsville
country: United States
facility: Medial Affiliated Research Center, Inc.
state: Alabama
city: Carmichael
country: United States
facility: Northern California Research Corp
state: California
city: Mission Viejo
country: United States
facility: Prime-Care Clinical Research
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Tallahassee,
country: United States
facility: Southeastern Research Group, Inc.
state: Florida
city: Fort Wayne
country: United States
facility: Northeast Indiana Research, LLC
state: Indiana
city: Madisonville,
country: United States
facility: Commonweatlh Biomedical Research
state: Kentucky
city: Baltimore
country: United States
facility: The Center for Sexual Medicine at Sheppard Pratt
state: Maryland
city: Livonia
country: United States
facility: Office of Keith Pierce, MD
state: Michigan
city: Las Vegas
country: United States
facility: Office of Michael Mall, MD
state: Nevada
city: Las Vegas
country: United States
facility: Office of Stephen Miller, MD
state: Nevada
city: Hackensack
country: United States
facility: Advanced Biomedical Research, Inc.
state: New Jersey
city: Lawrenceville
country: United States
facility: Office of Gary S. Karlin, MD
state: New Jersey
city: Nashville
country: United States
facility: Medical Research Associates of Nashville
state: Tennessee
city: San Antonio
country: United States
facility: Urology San Antonio Research, PA
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre van As, MD, PhD
role: STUDY_DIRECTOR
References: