Eligibility Details:
Men who meet all the following criteria are eligible for enrollment in the trial:
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 (inclusive) at the time of the screening visit.
3. BMI ≤36 calculated as weight in kg/ (height in m2).
4. No history of steroid hormone use in the three months prior to the first screening
visit or any current medication use which might interfere with steroid metabolism.
5. Subject agrees to use a recognized effective method of contraception with any female
partner (refer to Appendix 7 for acceptable forms of contraception) during the course
of the study treatment and recovery phases until recovery is confirmed and study exit
occurs.
6. Subjects will refrain from donating blood or plasma during the study period and from
participating in other investigational drug studies.
7. 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.)
8. Subjects will be advised to refrain from excessive marijuana consumption during the
study period. (No more than 3 uses per week and no consumption within 24 hours of a
study visit.)
9. 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.
10. Subjects will be advised to refrain/abstain from grapefruit juice during the study
period.
11. In the opinion of the investigator, subject is able to comply with the protocol,
understand and sign an informed consent and HIPAA form.
12. Subjects will be advised to refrain from major changes in their level of exercise
during the study period.
Men who meet any of the following criteria are NOT eligible for enrollment in the trial:
1. Men participating in another clinical trial involving an investigational drug within
the 30 days prior to the first screening visit.
2. Men not living in the catchment area of the clinic or within a reasonable distance
from the study site.
3. Clinically significant abnormal physical or laboratory findings at screening.
4. Elevated PSA (levels ≥ 2.5 ng/mL) at screening, according to local laboratory normal
values.
5. IPSS score ≥ 10.
6. Abnormal serum chemistry values at screening, according to local laboratory reference
ranges that indicate liver or kidney dysfunction or that may be considered clinically
significant. In addition, the following upper limits will be observed: fasting
bilirubin less than 2 mg/dL, cholesterol less than 221 mg/dL, and fasting
triglycerides less than 201 mg/dL.
7. Abnormal semen analyses or abnormal semen concentration as defined by the WHO semen
manual (< 15 million/mL).
8. Use of androgens within 3 months before first screening visit except for long acting
testosterone which requires a wash out period of 4 months prior to screening.
9. Ongoing use of androgens or other compounds for body building including nutritional
supplements.
10. Systolic BP ≥130 mm Hg and Diastolic blood pressure BP ≥ 80 and mm Hg; Blood pressure
(BP) will be taken 3 times at 5 - minute intervals and the mean of second and third
measurements will be used to determine eligibility. (Note: Diagnosis of hypertension
or treatment of hypertension is exclusionary.)
11. PHQ-9 score of 15 or above.
12. History of hypertension, including hypertension controlled with treatment.
13. Known history of primary testicular disease or disorders of the hypothalamic-pituitary
axis.
14. Benign or malignant liver tumors; active liver disease.
15. History of breast carcinoma.
16. Known history of androgen deficiency due to hypothalamic-pituitary or testicular
disease.
17. Known history of cardiovascular, renal, hepatic or prostatic disease or significant
psychiatric illness.
18. Positive serology for active Hepatitis (not immunization-related serology) or HIV at
screening visit.
19. A serious systemic disease such as diabetes mellitus.
20. History of known, untreated sleep apnea.
21. Partner is known to be pregnant.
22. Men desiring fertility within 12 months of signing consent for study participation.
23. Men participating in competitive sports where drug screening for prohibited substances
(including anabolic steroids) is routine. Exclusion is due to the potential of testing
positive for androgens that may occur from their study participation coupled with the
unknown efficacy (i.e. duration of positive testing) from 12-week daily use of DMAU.
24. Use of sex steroids or medications which might interfere with steroid metabolism (i.e.
ketoconazole, finasteride, oral corticosteroids, dutasteride and statins).
25. Use of medications that will interfere or interact with DMAU or LNG.
26. Known hypersensitivity to any of the active substances of DMAU, of the excipients of
the study treatment, or LNG.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
