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Healthy MenPhase 1DMAUPhase1NCT01382069

Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men

A Phase 1 study testing Dimethandrolone Undecanoate in people with Healthy Men and Male Contraception, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Men, Male Contraception
What is being tested?
Dimethandrolone Undecanoate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
2 sitesUnited States
Study dates
Mar 2012to May 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male volunteers in good health as confirmed by physical examination, medical history, and clinical laboratory tests of blood and urine at the time of screening.
  • 18 to 50 years of age.
  • BMI < 33 calculated as weight in kg/ (height in m2 )
  • No history of hormonal therapy use in the last three months prior to the first screening visit.
  • Subject will agree to use a recognized effective method of contraception with his partner (i.e. at a minimum, use double-barrier contraception) during the course of the study treatment and recovery phase.
  • Subjects will refrain from donating blood or plasma during the study period.
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  • Subjects will be advised to refrain/abstain from alcoholic beverages and grapefruit juice during the study period.
  • Subjects will not use cannabis or any recreational drugs at least 4 weeks before screening and during the study.
  • In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form.
  • Does not meet any of the exclusion criteria.

Who cannot join

  • Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
  • Men not living in the catchment's area of the clinic or within a reasonable distance from the study site.
  • Clinically significant abnormal physical and laboratory findings at screening.
  • Elevated PSA (levels ≥ 2.5 ng/mL), according to local laboratory normal values.
  • Abnormal serum chemistry values, according to local laboratory reference ranges that indicate liver or kidney dysfunction or that may be considered clinically significant except for: an upper limit for fasting bilirubin is less than 2 mg/dL, upper limit for cholesterol is less than 220 mg/dL, or upper limit for fasting triglycerides is less than 200 mg/dL.
  • Abnormal semen analyses or abnormal semen concentration as defined by the WHO semen manual.
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  • Use of androgens or other body building substances including nutritional supplements within 3 months before first screening visit.
  • Systolic BP > 130 mm Hg and Diastolic blood pressure BP > 80 and mm Hg; ((BP) Blood pressure will be taken 3 times at 5-minute intervals and the mean of all measurements be considered).
  • Clinically significant abnormal EKG and a QTc interval of > 450 msec.
  • PHQ-9 score of 15 or above [for the 28 days study].
  • History of hypertension, including hypertension controlled with treatment.
  • Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.
  • Benign or malignant liver tumors; active liver disease.
  • History of breast carcinoma.
  • Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease.
  • Known history of cardiac, renal, hepatic or prostatic disease.
  • Positive serology for Hepatitis or HIV at screening visit.
  • A serious systemic disease such as diabetes mellitus or obesity (body weight greater than BMI >33 kg/m2 as above).
  • History of known, untreated sleep apnea.
  • Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance.
  • Partner is known to be pregnant.
  • Men desiring fertility within the first 24 weeks of study participation.
  • Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their fertility or sporting status.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Washington

    Seattle, Washington, 98195

  • Los Angeles Biomedical Research Institute

    Torrance, California, 90502

Other trials in United States

About this study

Official title: Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men

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.

Read the detailed description

The study will be conducted in two centers.

28-Day Repeat-Dose, Dose-Escalation Study: Based on the safety and tolerability of the single dose study and serum DMA levels attained, three doses of two formulations of DMAU were selected for a dose-escalating 28-day repeat dose study. Safety will be assessed in subjects receiving lower dosages before additional men receive higher doses for 28 days. Up to 100 men will be randomized to receive either active drug or an identical number of capsules of placebo. The 24-hour detailed PK of DMA will be assessed on day 1 and 28. Trough levels of DMA will be obtained throughout the 28-day period and at 48 and 72 hours after the last dose. In addition to safety and tolerability, suppression of serum T, gonadotropins, and SHBG will also be assessed as secondary pharmacodynamic (PD) endpoints. Psychosexual diaries for 7 consecutive days and PHQ-9 (questionnaire)will be obtained before and at the end of the study period.

Being tested
Dimethandrolone Undecanoate, Placebo
Keywords
androgen, male contraception, dimethandrolone, healthy men

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dimethandrolone UndecanoateDrug

    Also called No other names

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

  • PlaceboDrug

    Also called no other names

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

Study groups in NCT01382069
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo
Dimethandrolone UndecanoateExperimentalDMAU group with different doses 100, 200 and 400 groups
Receives: Drug: Dimethandrolone Undecanoate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men

    Number of severe or serious adverse event fdter escalating single doses of Dimethandrolone Undecanoated in a single dose escalating study or after 28 days repeat dosing in healthy men

    Measured: 1 day

Secondary outcomes (3)
  1. Single Dose, Dose-Ranging and 28 days Repeat Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men

    Serum Dimethandrolone Levels on day 28

    Measured: 28 days

  2. Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men

    Serum Dimethandrolone levels

    Measured: 2 days Food or no food

  3. Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men

    Serum hormone levels (Testosterone (T), FSH and LH and SHBG) and sexual function.

    Measured: 28 DAYS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2011 (estimated)
  2. Study startMar 2012
  3. Primary completionFeb 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01382069
Sponsor's protocol ID
CCN010
Other IDs
HHSN275201000080U
Acronym
DMAUPhase1
Status last verified
Jul 2016
First submitted
25 Mar 2011
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Attardi BJ, Hild SA, Reel JR. Dimethandrolone undecanoate: a new potent orally active androgen with progestational activity. Endocrinology. 2006 Jun;147(6):3016-26. doi: 10.1210/en.2005-1524. Epub 2006 Feb 23.

    PubMed 16497801
  • Attardi BJ, Engbring JA, Gropp D, Hild SA. Development of dimethandrolone 17beta-undecanoate (DMAU) as an oral male hormonal contraceptive: induction of infertility and recovery of fertility in adult male rabbits. J Androl. 2011 Sep-Oct;32(5):530-40. doi: 10.2164/jandrol.110.011817. Epub 2010 Dec 16.

    PubMed 21164142
  • Attardi BJ, Marck BT, Matsumoto AM, Koduri S, Hild SA. Long-term effects of dimethandrolone 17beta-undecanoate and 11beta-methyl-19-nortestosterone 17beta-dodecylcarbonate on body composition, bone mineral density, serum gonadotropins, and androgenic/anabolic activity in castrated male rats. J Androl. 2011 Mar-Apr;32(2):183-92. doi: 10.2164/jandrol.110.010371. Epub 2010 Aug 26.

    PubMed 20798389
  • Yuen F, Thirumalai A, Fernando FA, Swerdloff RS, Liu PY, Pak Y, Hull L, Bross R, Blithe DL, Long JE, Page ST, Wang C. Comparison of metabolic effects of the progestational androgens dimethandrolone undecanoate and 11beta-MNTDC in healthy men. Andrology. 2021 Sep;9(5):1526-1539. doi: 10.1111/andr.13025. Epub 2021 May 22.

    PubMed 33908182
  • Thirumalai A, Yuen F, Amory JK, Hoofnagle AN, Swerdloff RS, Liu PY, Long JE, Blithe DL, Wang C, Page ST. Dimethandrolone Undecanoate, a Novel, Nonaromatizable Androgen, Increases P1NP in Healthy Men Over 28 Days. J Clin Endocrinol Metab. 2021 Jan 1;106(1):e171-e181. doi: 10.1210/clinem/dgaa761.

    PubMed 33090208
  • Thirumalai A, Ceponis J, Amory JK, Swerdloff R, Surampudi V, Liu PY, Bremner WJ, Harvey E, Blithe DL, Lee MS, Hull L, Wang C, Page ST. Effects of 28 Days of Oral Dimethandrolone Undecanoate in Healthy Men: A Prototype Male Pill. J Clin Endocrinol Metab. 2019 Feb 1;104(2):423-432. doi: 10.1210/jc.2018-01452.

    PubMed 30252061
  • Ayoub R, Page ST, Swerdloff RS, Liu PY, Amory JK, Leung A, Hull L, Blithe D, Christy A, Chao JH, Bremner WJ, Wang C. Comparison of the single dose pharmacokinetics, pharmacodynamics, and safety of two novel oral formulations of dimethandrolone undecanoate (DMAU): a potential oral, male contraceptive. Andrology. 2017 Mar;5(2):278-285. doi: 10.1111/andr.12303. Epub 2016 Dec 1.

    PubMed 27907978

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dimethandrolone Undecanoate in people with Healthy Men and Male Contraception, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01382069, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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