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Androgen Receptor Inhibitor

Injectable DMAU for Male Birth Control (DMAU Trial)

Phase 1
Recruiting
Led By Christina Wang, MD
Research Sponsored by Health Decisions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Weight ≥ 60 kg
Aged 18 to 50 years at the time of the enrollment visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-7 months
Awards & highlights

DMAU Trial Summary

This trial will study the safety and tolerability of a new drug, Dimethandrolone Undecanoate (DMAU), given as an injection.

Who is the study for?
Healthy male volunteers aged 18-50, weighing at least 60 kg with a BMI ≤ 33. Participants must not have used hormonal therapy in the past three months and agree to use effective contraception during the study. They should avoid major lifestyle changes, excessive alcohol, and drug use that affects hormone metabolism.Check my eligibility
What is being tested?
The trial is testing Dimethandrolone Undecanoate (DMAU) as a form of male birth control. It's a Phase I study where DMAU will be given either as an intramuscular or subcutaneous injection to assess its safety, how it's processed by the body, and its effectiveness.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include reactions typical for hormonal therapies such as mood changes, weight gain, acne or other skin issues, changes in libido or sexual function.

DMAU Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I weigh 60 kg or more.
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I am between 18 and 50 years old.
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I will not donate blood or plasma while in the study.

DMAU Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes from baseline in alanine aminotransferase (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Albumins
Alkaline Phosphatase
+17 more
Secondary outcome measures
Pharmacodynamics of DMAU by assessing the suppression of DHT using number of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of DHT using percentage of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of Dihydrotestosterone (DHT) using mean values at each visit
+18 more

DMAU Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dimethandrolone UndecanoateExperimental Treatment1 Intervention
Single doses of DMAU administered via injection intramuscularly (IM - 80 mg, 240 mg, 480 mg, and 800 mg) or administered subcutaneously (SC - 50 mg, 100 mg and 200 mg)
Group II: PlaceboPlacebo Group1 Intervention
Placebo injections that look like the DMAU injections but with no active ingredients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dimethandrolone Undecanoate
Not yet FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of WashingtonOTHER
1,732 Previous Clinical Trials
1,841,868 Total Patients Enrolled
Health DecisionsLead Sponsor
30 Previous Clinical Trials
13,813 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,956 Previous Clinical Trials
2,672,270 Total Patients Enrolled

Media Library

DMAU (Androgen Receptor Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02927210 — Phase 1
Male Birth Control Research Study Groups: Placebo, Dimethandrolone Undecanoate
Male Birth Control Clinical Trial 2023: DMAU Highlights & Side Effects. Trial Name: NCT02927210 — Phase 1
DMAU (Androgen Receptor Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02927210 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What kind of health risks does Dimethandrolone Undecanoate pose to individuals?

"There is sparse data on the safety and efficacy of Dimethandrolone Undecanoate, so it was rated a 1."

Answered by AI

Is this experiment still recruiting participants?

"Indeed, the clinicaltrial.gov records demonstrate that this research endeavour is currently recruiting participants. This trial was first made public on December 1st 2016 and last modified on July 7th 2021; 84 participants are needed at 2 sites."

Answered by AI

Does this medical trial accept individuals aged 85 or younger?

"According to the trial's requirements, only individuals aged between 18 and 50 are eligible for participation."

Answered by AI

Has there been any other research conducted regarding Dimethandrolone Undecanoate?

"Dimethandrolone Undecanoate was first researched at University of Washington Medical Center & Health Sciences in 2016, and has since seen 18330 completed trials. Currently, 1 clinical trial remains active; a significant proportion are based out of Torrance, CA."

Answered by AI

To what extent has participation been noted in this medical trial?

"Affirmative. Clinicaltrials.gov shows that this medical trial, which began recruiting on December 1st 2016, is currently accepting participants. 84 individuals are needed to take part in the study across 2 clinical sites."

Answered by AI

Could I potentially qualify for this experiment?

"This clinical trial seeks 84 individuals between 18 and 50 years of age to evaluate the efficacy of male contraception. It is essential that applicants meet the following criteria: abstain from too much alcohol consumption (no more than 15 drinks a week, no drinking 24hrs before study visit), be in good physical health with BMI ≤ 33, weigh ≥60 kg., have not used hormonal therapy within last three months prior to screening, agree to use an effective birth control method when engaging in sexual activity during the course of this experiment until recovery has been confirmed and exit occurs., refrain from donating blood or plasma for duration of study period., free from any drug"

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
~7 spots leftby Dec 2024