Effects of 28 Days of Oral Dimethandrolone Undecanoate in Healthy Men: A Prototype Male Pill.

ABSTRACT:

Context

Dimethandrolone (DMA) has androgenic and progestational activity. Single oral doses of DMA undecanoate (DMAU) were well tolerated and reversibly suppressed serum LH and testosterone (T) in men.

Objective

Assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of oral DMAU.

Design

Double-blind, randomized, placebo-controlled study.

Setting

Two academic medical centers.

Participants

Healthy men (18 to 50 years).

Interventions

One hundred men received DMAU [0, 100, 200, or 400 mg, formulated in castor oil/benzyl benzoate (C) or powder (P)] for 28 days. Subjects underwent 24-hour PK sampling on days 1 and 28 and twice weekly ambulatory visits throughout treatment.

Main outcome measures

Primary outcomes were safety

SUBMITTER: Thirumalai A 

PROVIDER: S-EPMC6306388 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature