Healthy Clinical Trial
Official title:
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial of Spermatogenesis Suppression After Oral Administration of Dimethandrolone Undecanote (DMAU) Alone or With Levonorgestrel (LNG) for 12 Weeks Versus Placebo Alone in Normal Men
This is a Phase IIa multicenter, double-blind, placebo-controlled study in healthy men to evaluate the spermatogenesis suppression after oral administration of Dimethandrolone Undecanoate (DMAU) alone or with Levonorgestrel (LNG) for 12 weeks versus placebo alone.
This 12 week repeated dose study will be conducted at two centers: the Los Angeles Biomedical
Research Institute at Harbor-UCLA Medical Center and the University of Washington. The sites
propose to enroll approximately 100 men with a goal of enrolling 20 healthy male subjects in
each of the 4 active groups and 20 in the placebo group for 12 weeks of treatment. The goal
is to complete at least 17 efficacy evaluable subjects in each group. The DMAU for this study
will be castor oil formulation administered after a 25 to 30 g fat meal. The oral dose of LNG
will be 30 mcg per day. The study volunteers will be randomized to one of five treatment
groups:
Group 1: Lower DMAU dose (100 mg per day) + LNG (30 mcg per day) (n=20) Group 2: Middle DMAU
dose (200mg per day) + LNG (30 mcg per day) (n=20) Group 3: Middle DMAU dose (200 mg per day)
+ placebo LNG (n=20) Group 4: Higher DMAU dose (400 mg per day) + placebo LNG (n=20) Group 5:
Placebo DMAU capsules and placebo LNG capsules (n=20)
Each treatment group will receive the identical number of capsules in blinded fashion so that
each subject will receive an identical number of capsules in order to maintain the blind.
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