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

NCT02927210 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: CCN015HHSN275201200002I
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Men; Male Contraception

Keywords

Healthy Men; Male Contraception; Androgen; Dimethandrolone

Outcome Measures

Primary Outcomes (20)

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

  5-7 months

• 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

  5-7 months

• 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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

Secondary Outcomes (21)

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

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

  5-7 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Dimethandrolone Undecanoate

EXPERIMENTAL

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)

Drug: Dimethandrolone Undecanoate

Interventions

Dimethandrolone Undecanoate DRUG

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).

Also known as: DMAU

Dimethandrolone Undecanoate

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.
• 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.
• \. Subjects will be advised to refrain from major changes in their level of exercise during the study period.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Kimberly Myer: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator
• University of Washington: collaborator

Study Sites (2)

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

University of Washington Medical Center & Health Sciences

Seattle, Washington, 98195, United States

Location

Related Publications (33)

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MeSH Terms

Interventions

dimethandrolone-undecanoate

Study Officials

• Christina Wang, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

• Stephanie Page Page, MD, PhD

  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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Program Director

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 6, 2016
• Study Start: February 15, 2017
• Primary Completion: November 7, 2024
• Study Completion: April 29, 2025
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (2)