Spots Global Cancer Trial Database for Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
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Trial Identification
Brief Title: Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
Official Title: A Study to Evaluate the Efficacy of Androxal® in Improving Glycemic Control in Men With Secondary Hypogonadism or Adult-onset Idiopathic Hypogonadotropic Hypogonadism (AIHH) and Type 2 Diabetes Mellitus With Sub-Optimum Treatment
Study ID: NCT01191320
Study Description
Brief Summary: The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism
Detailed Description: A phase IIB, multi-center, randomized, parallel, placebo- and active-controlled trial in adult male subjects with secondary hypogonadism who have been treated with OHAs but are not in glycemic control. All subjects currently treated with exogenous testosterone will discontinue at screening for at least 21 days and remain off testosterone for the course of the study. One hundred twenty to 150 subjects will be randomly assigned to one of three treatment groups according to a 1:1:1 ratio. Subjects will receive one of two dose strengths of Androxal or placebo in addition to their usual dose of mono- or combination OHAs for three months. Following an initial screening period, subjects will return monthly for 3 months and 1 month later for a follow-up visit.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Paradigm Clinical Research, Garden Grove, California, United States
Northern California Research Corp, Sacramento, California, United States
LABioMed, Torrance, California, United States
Lahey Clinic, Peabody, Massachusetts, United States
Affiliated Clinical Research, Las Vegas, Nevada, United States
Affiliated Clinical Research, Las Vegas, Nevada, United States
Dr. Bruce Gilbert, Great Neck, New York, United States
University Urology, New York, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
Dr. Michael Werner, Purchase, New York, United States
Discovery Clinical Trials, Austin, Texas, United States
Research Across America, Carrollton, Texas, United States
TX Urology Associate, Houston, Texas, United States
Centex Research, Houston, Texas, United States
Dr. Rakesh Patel, 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: Glenn Cunningham, MD
Affiliation: Baylor College of Medicine
Role: PRINCIPAL_INVESTIGATOR
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