At a glance
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Injectable DMAU for Male Contraception: Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Single IM or SC DMAU Injection Dose Escalation Study in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating Dimethandrolone Undecanoate and Placebo for Healthy Men and Male Contraception. Completed, enrolled 106 participants across 2 sites.
Detailed Summary
This is a Phase I multicenter, double-blind, single dose, dose-ranging study, in healthy men to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of Dimethandrolone Undecanoate (DMAU) administered as an intramuscular or subcutaneous injection.
Study Details
Timeline
Interventions
Single doses of DMAU in castor oil/benzyl benzoate injections intramuscularly (IM) (80 mg, 240 mg, 480 mg, and 800 mg) or administered subcutaneously (SC) (50 mg, 100 mg and 200 mg).
Placebo injections that look like the DMAU injections but with no active ingredients