At a glance
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Oral Androgens in Man-4: Gonadotropin Suppression Medicated by Oral Testosterone Enanthate in Oil Plus Dutasteride (Short Title: Oral T-4)
In Brief
A Phase 2 clinical trial evaluating Testosterone Enanthate, Dutasteride, and 1 other intervention for Contraception. Completed, enrolled 20 participants across 1 site.
Detailed Summary
The protocol was designed to address the hypothesis that oral testosterone enanthate plus dutasteride can suppress the secretion of LH and FSH after four weeks of administration. In addition, we will compare the gonadotropin suppression mediated by a dose of testosterone enanthate (400 mg twice daily) that would be expected to maintain the serum testosterone in the normal range throughout the day, with the same dose (800 mg once daily) administered once daily. This larger once-daily dose is expected to result in a higher peak and lower trough by the end of the dosing interval
Study Details
Timeline
Interventions
Oral Testosterone 400 mg orally for 28 days
Oral Testosterone 800 mg orally for 28 days
dutasteride 0.5 mg orally, once daily for 28 days
placebo sesame oil
24.5 mg po once (Day 0)