Clinical trial NCT00962637: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hypogonadism
Keywords: Secondary Hypogonadism
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-20
Enrollment: 194
Sex: MALE
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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: Six months
Secondary outcomes:
measure: Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel®
timeFrame: Six months
Other outcomes:
Locations:
city: Birmingham,
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Huntsville
country: United States
facility: Medical 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: Commonwealth 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
state: New Jersey
city: Nashville
country: United States
facility: Medial 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: