The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.
This study is a phase IIb, 4 arm study with three month active dosing period. Three of the four treatment groups will be randomized to either Androxal or placebo in a double-blind fashion, and the fourth treatment group will receive open-label Testim. The doses of Androxal in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
Paradigm Clinical Inc.
Garden Grove, California, United States
Northern California Research Corp
Sacramento, California, United States
Change in Total Morning Testosterone
Changes in values from baseline in total morning testosterone levels at month 3 comparing Androxal 12.5 and 25 mg to placebo and Testim
Time frame: 3 months
Change in Luteinizing Hormone Levels
Changes in values from baseline in LH at month 3
Time frame: 3 months
Change in FSH After 3 Months of Treatment
Time frame: 3 months
Reproductive Safety
Change from baseline in sperm concentration
Time frame: 3 months
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Medical Center for Clinical Research
San Diego, California, United States
Los Angeles Biomedical Research Institute
Torrance, California, United States
Affiliated Clinical Research
Las Vegas, Nevada, United States
Affiliated Clinical Research Inc.
Las Vegas, Nevada, United States
Weill Cornell Medical College and Smith Institute
Great Neck, New York, United States
Jed Kaminetsky
New York, New York, United States
Natan Bar-Chama
New York, New York, United States
Michael A Werner
Purchase, New York, United States
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