Healthy Men, Male Contraception
Conditions
Keywords
androgen, male contraception, dimethandrolone, healthy men
Brief 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.
Detailed description
The study will be conducted in two centers. 28-Day Repeat-Dose, Dose-Escalation Study: Based on the safety and tolerability of the single dose study and serum DMA levels attained, three doses of two formulations of DMAU were selected for a dose-escalating 28-day repeat dose study. Safety will be assessed in subjects receiving lower dosages before additional men receive higher doses for 28 days. Up to 100 men will be randomized to receive either active drug or an identical number of capsules of placebo. The 24-hour detailed PK of DMA will be assessed on day 1 and 28. Trough levels of DMA will be obtained throughout the 28-day period and at 48 and 72 hours after the last dose. In addition to safety and tolerability, suppression of serum T, gonadotropins, and SHBG will also be assessed as secondary pharmacodynamic (PD) endpoints. Psychosexual diaries for 7 consecutive days and PHQ-9 (questionnaire)will be obtained before and at the end of the study period.
Interventions
Daily doses of 100, 200 and 400mg of dimethandrolone undecanoate
DRUGPlacebo
Placebo with capsules that look like the DMAU capsules but with no active ingredients
Sponsors
National Institutes of Health (NIH)
University of Washington
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. 18 to 50 years of age. 3. BMI \< 33 calculated as weight in kg/ (height in m2 ) 4. No history of hormonal therapy use in the last three months prior to the first screening visit. 5. 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. 6. Subjects will refrain from donating blood or plasma during the study period. 7. Subjects will be advised to refrain/abstain from alcoholic beverages and grapefruit juice during the study period. 8. Subjects will not use cannabis or any recreational drugs at least 4 weeks before screening and during the study. 9. In the opinion of the investigator, subject is able to comply with the protocol, understand and sign an informed consent and HIPAA form. 10. Does not meet any of the
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men | 1 day | Number of severe or serious adverse event fdter escalating single doses of Dimethandrolone Undecanoated in a single dose escalating study or after 28 days repeat dosing in healthy men |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single Dose, Dose-Ranging and 28 days Repeat Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men | 28 days | Serum Dimethandrolone Levels on day 28 |
| Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men | 2 days Food or no food | Serum Dimethandrolone levels |
Countries
United States
Outcome results
None listed