Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men (NCT01382069) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men
United States100 participantsStarted 2012-03
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexMALE
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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.
✓. 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.
Exclusion criteria
What they're measuring
1
Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men
Timeframe: 1 day
Trial details
NCT IDNCT01382069
SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
. 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).