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 range
18 Years – 50 Years
Sex
MALE
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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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).