Healthy Men Clinical Trial
Official title:
Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men
The long term objective is to develop a new male hormone Dimethandrolone Undecanoate (DMAU)
as a male hormonal contraceptive.
The study has two parts. The first is a dose escalating study in healthy to assess the safety
and tolerability of single dose oral administration of DMAUin healthy men.(Completed)
The second is to study the safety and tolerability of DMAU after 28 days of repeated daily
dosing of DMAU in healthy men. (Currently Recruiting) In both parts the investigators will
also study the pharmacokinetics of Dimethandrolone (DMA) in the serum after oral
administration of DMAU.
The study will be conducted in two centers.
28-Day Repeat-Dose, Dose-Escalation Study: Based on the safety and tolerability of the single
dose study and serum DMA levels attained, three doses of two formulations of DMAU were
selected for a dose-escalating 28-day repeat dose study. Safety will be assessed in subjects
receiving lower dosages before additional men receive higher doses for 28 days. Up to 100 men
will be randomized to receive either active drug or an identical number of capsules of
placebo. The 24-hour detailed PK of DMA will be assessed on day 1 and 28. Trough levels of
DMA will be obtained throughout the 28-day period and at 48 and 72 hours after the last dose.
In addition to safety and tolerability, suppression of serum T, gonadotropins, and SHBG will
also be assessed as secondary pharmacodynamic (PD) endpoints. Psychosexual diaries for 7
consecutive days and PHQ-9 (questionnaire)will be obtained before and at the end of the study
period.
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