Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men

NCT01382069 | Completed Phase 1 DMC

• 2 other identifiers: CCN010HHSN275201000080U
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Healthy Men; Male Contraception

Keywords

androgen; male contraception; dimethandrolone; healthy men

Outcome Measures

Primary Outcomes (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

  1 day

Secondary Outcomes (3)

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

  28 days

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

  2 days Food or no food

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

  28 DAYS

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Dimethandrolone Undecanoate

EXPERIMENTAL

DMAU group with different doses 100, 200 and 400 groups

Drug: Dimethandrolone Undecanoate

Interventions

Dimethandrolone Undecanoate DRUG

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

Also known as: No other names

Dimethandrolone Undecanoate

Placebo DRUG

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

Also known as: no other names

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• National Institutes of Health (NIH): collaborator
• University of Washington: collaborator

Study Sites (2)

Los Angeles Biomedical Research Institute

Torrance, California, 90502, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (7)

• 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.

  PMID: 16497801 BACKGROUND

• 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.

  PMID: 21164142 BACKGROUND

• 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.

  PMID: 20798389 BACKGROUND

• 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.

  PMID: 33908182 DERIVED

• 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.

  PMID: 33090208 DERIVED

• 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.

  PMID: 30252061 DERIVED

• 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.

  PMID: 27907978 DERIVED

MeSH Terms

Interventions

dimethandrolone-undecanoate

Study Officials

• Christina Wang, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

• Stephanie Page, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2011
• First Posted: June 27, 2011
• Study Start: March 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: May 1, 2017
• Last Updated: November 20, 2025

Record last verified: 2016-07

Locations

US (2)