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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

Must not have

Abnormal serum chemistry values at screening indicating liver or kidney dysfunction

Ongoing use of body building substances including nutritional supplements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood tests show liver or kidney problems.

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I am currently using body building substances or nutritional supplements.

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I have liver tumors or active liver disease.

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I have had breast cancer before.

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I have a known androgen deficiency due to a brain or testicular condition.

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I have a history of heart, kidney, liver, prostate issues, or significant mental health problems.

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I have a history of testicular disease or hormonal control issues.

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I have sleep apnea that has not been treated.

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I am not taking medications that interact with DMAU.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

0 / 12Eligibility criteria met