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Healthy MenPhase 1DMAUNCT02927210

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

A Phase 1 study testing Dimethandrolone Undecanoate in people with Healthy Men and Male Contraception, run by Kimberly Myer 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

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. 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
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
106 participants
Where
2 sitesUnited States
Study dates
15 Feb 2017to 29 Apr 2025
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

  • Men who meet all the following criteria are eligible for enrollment in the trial:
  • 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 (inclusive) at the time of the enrollment visit.
  • BMI ≤ 33 calculated as weight in kg/ (height in m2).
  • Weight ≥60 kg.
  • No history of hormonal therapy use in the three months prior to the first screening visit.
Show all 12Show fewer
  • Agree to use a recognized effective method of contraception with any female partner (i.e. at a minimum, barrier plus an additional method of contraception) during the course of the study treatment and recovery phases until recovery is confirmed and study exit occurs.
  • Subjects will refrain from donating blood or plasma during the study period.
  • Subjects will be advised to refrain from excessive alcoholic consumption during the study period. (No more than 15 drinks per week and no alcohol consumption within 24 hours of a study visit.)
  • No known or suspected current alcohol dependence syndrome, chronic marijuana use, or any illicit drug use that may affect metabolism/transformation of steroid hormones and study treatment compliance.
  • In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form.
  • 12. Subjects will be advised to refrain from major changes in their level of exercise during the study period.

Who cannot join

  • Men who meet any of the following criteria are NOT eligible for enrollment in the trial:
  • Men participating in another clinical trial involving an investigational drug within the 30 days prior to the first screening visit.
  • Men not living in the catchment 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) at screening, according to local laboratory normal values.
  • Abnormal serum chemistry values at screening, according to local laboratory reference ranges that indicate liver or kidney dysfunction or that may be considered clinically significant. In addition, the following upper limits will be observed: fasting bilirubin less than 2 mg/dL, cholesterol less than 221 mg/dL, and fasting triglycerides less than 201 mg/dL.
Show all 25Show fewer
  • Abnormal semen analyses or abnormal semen concentration as defined by the WHO semen manual.
  • Use of androgens within 3 months before first screening visit except for long acting testosterone injections (e.g. Testosterone undecanoate) which will require a wash out period of 6 months prior to screening.
  • Ongoing use of body building substances including nutritional supplements.
  • Systolic BP > 130 mm Hg and Diastolic blood pressure BP > 80 and mm Hg; Blood pressure (BP) will be taken 3 times at 5 - minute intervals and the mean of all measurements be used to determine eligibility).
  • Clinically significant abnormal EKG or a QTc interval of > 450 msec.
  • PHQ-9 score of 15 or above.
  • 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 cardiovascular, renal, hepatic or prostatic disease or significant psychiatric illness.
  • Positive serology for active Hepatitis (not immunization-related serology) 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.
  • 22. Partner is known to be pregnant. 23. Men desiring fertility within the first seven months of study participation.
  • 24. Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine. Exclusion is due to the potential of testing positive for androgens that may occur from their study participation coupled with the unknown efficacy (i.e. duration of positive testing) from a single injection.
  • 26. Use of sex steroids or medications which might interfere with steroid metabolism (i.e. ketoconazole, finasteride, oral corticosteroids, dutasteride and statins).
  • 27. Use of medications that will interfere or interact with DMAU.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Washington Medical Center & Health Sciences

    Seattle, Washington, 98195

  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

    Torrance, California, 90509

Other trials in United States

About this study

Official title: Injectable DMAU for Male Contraception: Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Single IM or SC DMAU Injection Dose Escalation Study in Healthy Male Volunteers

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.

Read the detailed description

This single dose, dose-ranging study will be conducted in two centers: the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and the University of Washington.

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) were selected for this dose-escalating study. Twelve subjects will complete this study at each of the DMAU doses (10 on DMAU and 2 on placebo injections) yielding a total of 84 completed subjects (70 on DMAU and 14 on placebo) across both sites. Safety will be assessed in all subjects and recovery will be assessed in two subjects receiving lower doses, either IM or SC, before additional men receive higher doses of IM or SC of DMAU. In addition to safety and tolerability, suppression of serum T, E2, gonadotropins, and SHBG will be assessed as secondary pharmacodynamic (PD) endpoints. PK of DMAU and DMA will be assessed through blood draws done at each visit. Suppression of spermatogenesis will be assessed with semen analysis.

DMAU injections will be administered at the study site by research nurses or physicians. For intramuscular injections, the staff will inject DMAU in castor oil into the gluteal region following standard procedures for intramuscular steroid injection. Abdominal subcutaneous injections will follow standard subcutaneous procedures. The subject will be observed for at least 30 minutes before release from the study site.

Being tested
Dimethandrolone Undecanoate, Placebo
Keywords
Healthy Men, Male Contraception, Androgen, Dimethandrolone

What participants receive

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

  • Dimethandrolone UndecanoateDrug

    Also called DMAU

    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).

  • PlaceboDrug

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

Study groups in NCT02927210
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo injections that look like the DMAU injections but with no active ingredients
Receives: Drug: Placebo
Dimethandrolone UndecanoateExperimentalSingle 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)
Receives: Drug: Dimethandrolone Undecanoate

What is being measured

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

  1. Incidence of treatment emergent adverse events (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  2. Changes from baseline in sexual function (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU) using the psychosexual daily questionnaire

    Measured: 5-7 months

  3. Changes from baseline in mood (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU) using the Patient Health Questionnaire-9

    Measured: 5-7 months

  4. Changes from baseline in sodium (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  5. Changes from baseline in potassium (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  6. Changes from baseline in chloride (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  7. Changes from baseline in bicarbonate (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  8. Changes from baseline in fasting glucose (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  9. Changes from baseline in blood urea nitrogen (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  10. Changes from baseline in creatinine (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  11. Changes from baseline in calcium (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  12. Changes from baseline in total bilirubin (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  13. Changes from baseline in alkaline phosphatase (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  14. Changes from baseline in alanine aminotransferase (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  15. Changes from baseline in aspartate transaminase (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  16. Changes from baseline in albumin (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  17. Changes from baseline in blood pressure (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  18. Changes from baseline in pulse (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  19. Changes from baseline in respiratory rate (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

  20. Changes from baseline in body mass index (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)

    Measured: 5-7 months

Secondary outcomes (21)

  1. Pharmacokinetics of DMAU and DMA using AUC (0-t, where t is the last time-point with measurable concentration)

    Measured: 5-7 months

  2. Pharmacodynamics of DMAU by assessing the suppression of serum Testosterone (T) using mean values at each visit

    Measured: 5-7 months

  3. Pharmacodynamics of DMAU by assessing the suppression of Dihydrotestosterone (DHT) using mean values at each visit

    Measured: 5-7 months

  4. Pharmacodynamics of DMAU by assessing the suppression of Estradiol (E2) using mean values at each visit

    Measured: 5-7 months

  5. Pharmacodynamics of DMAU by assessing the suppression of Follicle Stimulating Hormone (FSH) using mean values at each visit

    Measured: 5-7 months

  6. Pharmacodynamics of DMAU by assessing the suppression of Luteinizing Hormone (LH) using mean values at each visit

    Measured: 5-7 months

  7. Pharmacodynamics of DMAU by assessing the suppression of Sex Hormone Binding Globulin (SHBG) using mean values at each visit

    Measured: 5-7 months

  8. Pharmacodynamics of DMAU by assessing the suppression of serum T using number of subjects with FSH and LH ≤ 1.0 IU/L

    Measured: 5-7 months

  9. Pharmacodynamics of DMAU by assessing the suppression of serum T using percentage of subjects with FSH and LH ≤ 1.0 IU/L

    Measured: 5-7 months

  10. Pharmacodynamics of DMAU by assessing the suppression of DHT using number of subjects with FSH and LH ≤ 1.0 IU/L

    Measured: 5-7 months

  11. Pharmacodynamics of DMAU by assessing the suppression of DHT using percentage of subjects with FSH and LH ≤ 1.0 IU/L

    Measured: 5-7 months

  12. Pharmacodynamics of DMAU by assessing the suppression of E2 using number of subjects with FSH and LH ≤ 1.0 IU/L

    Measured: 5-7 months

  13. Pharmacodynamics of DMAU by assessing the suppression of E2 using percentage of subjects with FSH and LH ≤ 1.0 IU/L

    Measured: 5-7 months

  14. Pharmacodynamics of DMAU by assessing the suppression of FSH using number of subjects with FSH and LH ≤ 1.0 IU/L

    Measured: 5-7 months

  15. Pharmacodynamics of DMAU by assessing the suppression of FSH using of subjects with FSH and LH ≤ 1.0 IU/L

    Measured: 5-7 months

  16. Pharmacodynamics of DMAU by assessing the suppression of LH using number of subjects with FSH and LH ≤ 1.0 IU/L

    Measured: 5-7 months

  17. Pharmacodynamics of DMAU by assessing the suppression of LH using percentage of subjects with FSH and LH ≤ 1.0 IU/L

    Measured: 5-7 months

  18. Pharmacodynamics of DMAU by assessing the suppression of SHBG using number of subjects with FSH and LH ≤ 1.0 IU/L

    Measured: 5-7 months

  19. Pharmacodynamics of DMAU by assessing the suppression of SHBG using percentage of subjects with FSH and LH ≤ 1.0 IU/L

    Measured: 5-7 months

  20. Suppression of spermatogenesis as assessed by semen analyses using number of subjects with sperm concentration <1 million (M)/mL

    Measured: 5-7 months

  21. Suppression of spermatogenesis as assessed by semen analyses using percentage of subjects with sperm concentration <1 million (M)/mL

    Measured: 5-7 months

Timeline

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

  1. First posted6 Oct 2016 (estimated)
  2. Study start15 Feb 2017
  3. Primary completion7 Nov 2024
  4. Study completion29 Apr 2025

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02927210
Sponsor's protocol ID
CCN015
Other IDs
HHSN275201200002I
Acronym
DMAU
Status last verified
Oct 2025
First submitted
28 Sep 2016
Last updated
31 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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, Hild SA, Koduri S, Pham T, Pessaint L, Engbring J, Till B, Gropp D, Semon A, Reel JR. The potent synthetic androgens, dimethandrolone (7alpha,11beta-dimethyl-19-nortestosterone) and 11beta-methyl-19-nortestosterone, do not require 5alpha-reduction to exert their maximal androgenic effects. J Steroid Biochem Mol Biol. 2010 Oct;122(4):212-8. doi: 10.1016/j.jsbmb.2010.06.009. Epub 2010 Jun 25.

    PubMed 20599615

  • 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

  • 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, Pham TC, Radler LC, Burgenson J, Hild SA, Reel JR. Dimethandrolone (7alpha,11beta-dimethyl-19-nortestosterone) and 11beta-methyl-19-nortestosterone are not converted to aromatic A-ring products in the presence of recombinant human aromatase. J Steroid Biochem Mol Biol. 2008 Jun;110(3-5):214-22. doi: 10.1016/j.jsbmb.2007.11.009.

    PubMed 18555683

  • Cook CE, Kepler JA. 7alpha,11beta-Dimethyl-19-nortestosterone: a potent and selective androgen response modulator with prostate-sparing properties. Bioorg Med Chem Lett. 2005 Feb 15;15(4):1213-6. doi: 10.1016/j.bmcl.2004.11.076.

    PubMed 15686944

  • Cummings DE, Kumar N, Bardin CW, Sundaram K, Bremner WJ. Prostate-sparing effects in primates of the potent androgen 7alpha-methyl-19-nortestosterone: a potential alternative to testosterone for androgen replacement and male contraception. J Clin Endocrinol Metab. 1998 Dec;83(12):4212-9. doi: 10.1210/jcem.83.12.5324.

    PubMed 9851754

  • Frey-Wettstein M, Craddock CG. Testosterone-induced depletion of thymus and marrow lymphocytes as related to lymphopoiesis and hematopoiesis. Blood. 1970 Mar;35(3):257-71. No abstract available.

    PubMed 4908652

  • Gu Y, Liang X, Wu W, Liu M, Song S, Cheng L, Bo L, Xiong C, Wang X, Liu X, Peng L, Yao K. Multicenter contraceptive efficacy trial of injectable testosterone undecanoate in Chinese men. J Clin Endocrinol Metab. 2009 Jun;94(6):1910-5. doi: 10.1210/jc.2008-1846. Epub 2009 Mar 17.

    PubMed 19293262

  • Gu YQ, Wang XH, Xu D, Peng L, Cheng LF, Huang MK, Huang ZJ, Zhang GY. A multicenter contraceptive efficacy study of injectable testosterone undecanoate in healthy Chinese men. J Clin Endocrinol Metab. 2003 Feb;88(2):562-8. doi: 10.1210/jc.2002-020447.

    PubMed 12574181

  • Hild SA, Attardi BJ, Koduri S, Till BA, Reel JR. Effects of synthetic androgens on liver function using the rabbit as a model. J Androl. 2010 Sep-Oct;31(5):472-81. doi: 10.2164/jandrol.109.009365. Epub 2010 Apr 8.

    PubMed 20378929

  • Ilani N, Roth MY, Amory JK, Swerdloff RS, Dart C, Page ST, Bremner WJ, Sitruk-Ware R, Kumar N, Blithe DL, Wang C. A new combination of testosterone and nestorone transdermal gels for male hormonal contraception. J Clin Endocrinol Metab. 2012 Oct;97(10):3476-86. doi: 10.1210/jc.2012-1384. Epub 2012 Jul 12.

    PubMed 22791756

  • Lee KK, Berman N, Alexander GM, Hull L, Swerdloff RS, Wang C. A simple self-report diary for assessing psychosexual function in hypogonadal men. J Androl. 2003 Sep-Oct;24(5):688-98. doi: 10.1002/j.1939-4640.2003.tb02728.x.

    PubMed 12954659

  • Kaminetsky J, Jaffe JS, Swerdloff RS. Pharmacokinetic Profile of Subcutaneous Testosterone Enanthate Delivered via a Novel, Prefilled Single-Use Autoinjector: A Phase II Study. Sex Med. 2015 Sep 17;3(4):269-79. doi: 10.1002/sm2.80. eCollection 2015 Dec.

    PubMed 26797061

  • Keenan CM, Vidal JD. Standard morphologic evaluation of the heart in the laboratory dog and monkey. Toxicol Pathol. 2006;34(1):67-74. doi: 10.1080/01926230500369915.

    PubMed 16507546

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 Kimberly Myer 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 12 inclusion and 25 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 31 Oct 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?

Incidence of treatment emergent adverse events (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU) (time frame: 5-7 months). The study lists 20 primary outcomes in all. 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 NCT02927210, which also lists 33 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 31 Oct 2025.

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