Spots Global Cancer Trial Database for Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
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Trial Identification
Brief Title: Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
Official Title: A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism
Study ID: NCT01270841
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Paradigm Clinical Inc., Garden Grove, California, United States
Northern California Research Corp, Sacramento, California, United States
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
Discovery Clinical Trials, Austin, Texas, United States
Research Across America, Carrollton, Texas, United States
Texas Urology Specialist, Houston, Texas, United States
Centex Research, Houston, Texas, United States
Endocrine and Psychiatry Center, Houston, Texas, United States
Protenium Clinical Research, Hurst, Texas, United States
R/D Clinical Research, Lake Jackson, Texas, United States
Cetero Research, San Antonio, Texas, United States
Contact Details
Name: Larry Lipshultz, MD
Affiliation: Baylor College of Medicine
Role: PRINCIPAL_INVESTIGATOR
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