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Injectable DMAU for Male Contraception in Healthy Male Volunteers (CCN015)

NCT02927210 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-10-31

No results posted yet for this study

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.

Conditions

  • Healthy Men
  • Male Contraception

Interventions

DRUG

Dimethandrolone Undecanoate

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).

DRUG

Placebo

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

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

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Kimberly Myer

    lead OTHER

Principal Investigators

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

  • Stephanie Page Page, MD, PhD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2024-11-07
Completion
2025-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02927210 on ClinicalTrials.gov