Dimethandrolone Undecanoate for Male Contraception

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Washington Medical Center & Health Sciences, Seattle, WA
Male Contraception+1 More
Dimethandrolone Undecanoate - Drug
Eligibility
18 - 65
Male
Eligible conditions
Select

Study Summary

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

See full description

Eligible Conditions

  • Male Contraception
  • Healthy Men

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Dimethandrolone Undecanoate will improve 20 primary outcomes and 21 secondary outcomes in patients with Male Contraception. Measurement will happen over the course of 5-7 months.

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)
Changes from baseline in albumin (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Changes from baseline in alkaline phosphatase (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Changes from baseline in aspartate transaminase (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Changes from baseline in bicarbonate (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Changes from baseline in blood pressure (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Changes from baseline in blood urea nitrogen (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Changes from baseline in body mass index (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Changes from baseline in calcium (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Changes from baseline in chloride (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Changes from baseline in creatinine (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Changes from baseline in fasting glucose (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
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
Changes from baseline in potassium (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Changes from baseline in pulse (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Changes from baseline in respiratory rate (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
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
Changes from baseline in sodium (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Changes from baseline in total bilirubin (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Incidence of treatment emergent adverse events (safety and tolerability) with a single IM or SC injection of escalating doses of Dimethandrolone Undecanoate (DMAU)
Pharmacodynamics of DMAU by assessing the suppression of DHT using number of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of DHT using percentage of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of Dihydrotestosterone (DHT) using mean values at each visit
Pharmacodynamics of DMAU by assessing the suppression of E2 using number of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of E2 using percentage of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of Estradiol (E2) using mean values at each visit
Pharmacodynamics of DMAU by assessing the suppression of FSH using number of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of FSH using of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of Follicle Stimulating Hormone (FSH) using mean values at each visit
Pharmacodynamics of DMAU by assessing the suppression of LH using number of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of LH using percentage of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of Luteinizing Hormone (LH) using mean values at each visit
Pharmacodynamics of DMAU by assessing the suppression of SHBG using number of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of SHBG using percentage of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of Sex Hormone Binding Globulin (SHBG) using mean values at each visit
Pharmacodynamics of DMAU by assessing the suppression of serum T using number of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of serum T using percentage of subjects with FSH and LH ≤ 1.0 IU/L
Pharmacodynamics of DMAU by assessing the suppression of serum Testosterone (T) using mean values at each visit
Pharmacokinetics of DMAU and DMA using AUC (0-t, where t is the last time-point with measurable concentration)
Suppression of spermatogenesis as assessed by semen analyses using number of subjects with sperm concentration <1 million (M)/mL
Suppression of spermatogenesis as assessed by semen analyses using percentage of subjects with sperm concentration <1 million (M)/mL

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Dimethandrolone Undecanoate
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 84 total participants across 2 different treatment groups

This trial involves 2 different treatments. Dimethandrolone Undecanoate is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Dimethandrolone Undecanoate
Drug
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)
Placebo
Drug
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

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5-7 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5-7 months for reporting.

Closest Location

University of Washington Medical Center & Health Sciences - Seattle, WA

Eligibility Criteria

This trial is for male patients between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.
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.

Patient Q&A Section

What are the signs of healthy men?

"The use of validated self-report measures of men's psychosocial health provides objective evidence for a specific set of signs and symptoms that correspond to different aspects of men's health." - Anonymous Online Contributor

Unverified Answer

What is healthy men?

"There is a large discrepancy between the popular and scientific understanding of healthy men - "the healthy norm" that we are all supposedly aligned with - and the scientific truth of what we can do to boost healthy living and reduce disease. We need not be afraid or self-conscious about our healthy attributes in order to be more physically and mentally fit." - Anonymous Online Contributor

Unverified Answer

What causes healthy men?

"The healthy male is a healthy man even if he doesn’t have all the typical illnesses and disorders like other males. There must be other factors that help balance out the risks of physical illness that can manifest in many other diseases." - Anonymous Online Contributor

Unverified Answer

What are common treatments for healthy men?

"Most men are able to manage their symptoms of PE through some combination of counseling, lifestyle changes, non-pharmacologic interventions, and medications. If the case of PE is more severe, and if treatment is contemplated, then therapy includes non-pharmacologic treatments and medications. Many of the treatment approaches may be ineffective or have limited efficacy for symptomatic management. Physicians are encouraged to be open and honest about such issues with men who have questions regarding PE treatment." - Anonymous Online Contributor

Unverified Answer

Can healthy men be cured?

"Although healthy men do not develop [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), they develop prostate-related symptoms. Once prostate cancer is identified, those men with benign disease can have significant improvements in EFQoL and their symptoms." - Anonymous Online Contributor

Unverified Answer

How many people get healthy men a year in the United States?

"The 1 in 14 chance of an early death from prostate cancer was highest among all men who were not healthy in the last three years." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in dimethandrolone undecanoate for therapeutic use?

"• This new product provides a novel, well-tolerated method of delivery, offering further potential for the enhancement of potency and efficacy. • Long-term studies are required to evaluate safety concerns. • A systematic review is needed to determine whether DMD induces prostate cancer and/or inhibits fertility in men treated with it." - Anonymous Online Contributor

Unverified Answer

Does dimethandrolone undecanoate improve quality of life for those with healthy men?

"This analysis suggests that DHT undecanoate may improve some aspects of quality of life in men without clinical indications of a more severely impaired quality of life. Results from a recent clinical trial may not be relevant to those taking DHT for longer periods of time." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for healthy men?

"Most men with benign prostate disease want to be involved in a clinical trial of a treatment of disease, particularly if the prostate cancer is being screened. A number of the men were concerned about having their symptoms relieved, but the main reason for participation was the chance to participate in an active treatment. The findings support the concept that some men may be offered a treatment that does not alter their prostate, and that some of those who enroll in a trial would give these options a more critical reassessment." - Anonymous Online Contributor

Unverified Answer

Is dimethandrolone undecanoate safe for people?

"The use of 10 g of DMDU in men with low body mass and low risk for androgen insensitivity syndrome is well tolerated and effective." - Anonymous Online Contributor

Unverified Answer

How serious can healthy men be?

"Men, especially those under the age of 50, who are suffering from chronic disease are at greater risk of death as they age and can be hospitalized and have higher health care costs compared to their counterparts with only acute illnesses. When diagnosed with chronic disease, men under the age of thirty are at even greater risk due to their higher rates of mortality." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of dimethandrolone undecanoate?

"Common side effects of dimethandrolone undecanoate include feminization, headaches, nausea, and dizziness. Other uncommon side effects include depression, decreased libido, sexual dysfunction, insomnia, and constipation. Physicians should discuss the available side effects with their patients." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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