ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
499
Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
Change From Baseline in Total Morning Testosterone at 26 Weeks
Changes in values from baseline of total morning testosterone levels at Week 26
Time frame: 6 months
Change From Baseline in LH
Mean change from baseline in LH at end of treatment (26 weeks)
Time frame: 6 months
Absolute Values of Morning Testosterone
Absolute values of morning testosterone at end of treatment (26 weeks)
Time frame: 6 months
Mean Change From Baseline FPG
Mean changes in Fasting Plasma Glucose from baseline to end of treatment (26 weeks)
Time frame: 6 months
Change From Baseline in BMI
Mean change from baseline in BMI at end of treatment (26 weeks)
Time frame: 6 months
Change From Baseline in FSH
Change from baseline in FSH at end of treatment (26 weeks)
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 21 more locations