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Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men

NCT01382069 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-11-20

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Men
  • Male Contraception

Interventions

DRUG

Dimethandrolone Undecanoate

Daily doses of 100, 200 and 400mg of dimethandrolone undecanoate

DRUG

Placebo

Placebo with capsules that look like the DMAU capsules but with no active ingredients

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Washington

    collaborator OTHER

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    lead OTHER

Principal Investigators

  • Christina Wang, MD · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  • Stephanie Page, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2017-02-28
Completion
2017-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382069 on ClinicalTrials.gov