The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\<350 ng/dL)after 6 weeks of continuous dosing.
Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
capsule oral 1X a day 6 weeks
topical gel 1X a day 6 weeks
Centex Research
Houston, Texas, United States
Cetero Research
San Antonio, Texas, United States
24 Hour Average and Maximum Testosterone Concentration
The primary efficacy endpoint will be 24-hour average (TTavg) and maximum (TTmax) testosterone concentration compared to baseline after 6 weeks of treatment. Time points (in hours after dosing) at which testosterone concentration was measured are: 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24.
Time frame: Baseline and Week 6
Change in Leuteinizing Hormone (LH)
Changes in morning LH after continuous dosing
Time frame: Baseline, Week 2, Week 4, Week 6
Change in Follicle Stimulating Hormone (FSH)
Changes in morning FSH after continuous dosing
Time frame: Baseline, Week 2, Week 4, Week 6
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