Repros Low Testosterone ZA-300
An Open Label, Escalating Dose, 6 Month Phase III Safety Study of Enclomiphene Citrate in the Treatment of Men with Secondary Hypogonadism.
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| Identifier | ZA-300 |
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| UID | e09fa42c-bd27-4dab-89ce-b2ce6004ed0c |
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| Status | Done - Archived |
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| Phase | 3 |
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| Category | Low Testosterone |
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| Launch Year | 2012 |
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| NCT Number | - |
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| Created | 2012-05-07 11:22 |
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| Last Updated | 2012-05-07 11:22 |
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Description
Indication: This study is a phase III safety study with a 26 week active dosing period. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy eye exams, clinical laboratory tests and adverse event reporting.
Key Elements:
•Male subjects with secondary hypogonadal
•Subjects should be able to make early morning appointments for the blood draws. This should take place prior to 10:00 a.m.
•Subjects currently using topical testosterone products should wash-out for a t least 7 days before visit 1.
•BMI should be > 25 and < 42.
•Total study participation 9 months with study visits weekly to allow initial dosing adjustments.
Comment
No comment.
