Spots Global Cancer Trial Database for Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
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Trial Identification
Brief Title: Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Official Title: An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
Study ID: NCT01534208
Conditions
Interventions
Study Description
Brief Summary: ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.
Detailed Description: This study is a phase III, open label safety study with a six month active dosing period. All subjects will be started at 12.5 mg Androxal and titrated to 25 mg if needed. Safety will be assessed by physical and visual acuity exams, slit lamp eye exams, clinical laboratory tests and adverse event reporting.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Clinical Research Advantage, Glendale, Arizona, United States
Clinical Research Advantage, Phoenix, Arizona, United States
Baptist Health Center for Clinical Research, Little Rock, Arkansas, United States
Catalina Research Institute, Chino, California, United States
SC Clinical Research, Garden Grove, California, United States
South Orange County Endocrinology, Laguna Hills, California, United States
Anthony Mills, MD, Los Angeles, California, United States
SD Uro-Research, San Diego, California, United States
San Diego Sexual Medicine, San Diego, California, United States
SC Clinical Research, Santa Ana, California, United States
West Coast Clinical Research, Tarzana, California, United States
Clinical Research Advantage, Colorado Springs, Colorado, United States
Clinical Research Advantage, Colorado Springs, Colorado, United States
Meridien Research, Bradenton, Florida, United States
Florida Fertility Institute, Clearwater, Florida, United States
Therafirst Medical Center, Fort Lauderdale, Florida, United States
East Coast Institute for Clinical Research, Jacksonville, Florida, United States
East Coast Institute for Research, Jacksonville, Florida, United States
East Coast Institute for Research, Jacksonville, Florida, United States
Cetero Research, Miami Gardens, Florida, United States
Well Pharma Medical Research, Miami, Florida, United States
DMI Research, Pinellas Park, Florida, United States
Ebon Bourne, MD, Plantation, Florida, United States
Meridien Research, St. Petersburg, Florida, United States
IRC Clinics, Towson, Maryland, United States
Premier Urology Associates, Lawrenceville, New Jersey, United States
Advances in Health, Houston, Texas, United States
Breco Research, Sugar Land, Texas, United States
Center of Reproductive Medicine, Webster, Texas, United States
Lone Peak Family Medicine, Draper, Utah, United States
Granger Medical Clin ic, Riverton, Utah, United States
Contact Details
Name: Joseph S Podolski
Affiliation: Repros Therapeutics Inc.
Role: STUDY_CHAIR
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