CompletedPhase 1

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

United States106 participantsStarted 2017-02-15

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.)

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 5-7 months

Trial details

NCT IDNCT02927210

SponsorKimberly Myer

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-07

View on ClinicalTrials.gov More Healthy Men trials

Who can participate

Age range18 Years – 50 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.)

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 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

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 5-7 months