Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men (DMAUPhase1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01382069
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : July 2, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of Washington
Information provided by (Responsible Party):
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Tracking Information
First Submitted Date  ICMJE March 25, 2011
First Posted Date  ICMJE June 27, 2011
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE March 2012
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2014)
Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
  • Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men [ Time Frame: 1 day ]
    Number of severe or serious adverse event adter escalating single doses of Dimethandrolone Undecanoated in a single dose- escalatinng study in helathy men
  • Safety and Tolerability of DMAU in a 28 days study [ Time Frame: 28 days ]
    Number of severe or serious adverse events of DMAU in a 28 days repeat dose study
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
  • Single Dose, Dose-Ranging and 28 days Repeat Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men [ Time Frame: 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 [ Time Frame: 2 days Food or no food ]
    Serum Dimethandrolone levels
  • Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in Healthy Men [ Time Frame: 28 DAYS ]
    Serum hormone levels (Testosterone (T), FSH and LH and SHBG) and sexual function.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men
Official Title  ICMJE Single Dose, Dose-Ranging and 28-Day Repeat-Dose Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Dimethandrolone Undecanoate (DMAU) in 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy Men
  • Male Contraception
Intervention  ICMJE
  • Drug: Dimethandrolone Undecanoate
    Daily doses of 100, 200 and 400mg of dimethandrolone undecanoate
    Other Name: No other names
  • Drug: Placebo
    Placebo with capsules that look like the DMAU capsules but with no active ingredients
    Other Name: no other names
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: Dimethandrolone Undecanoate
    DMAU group with different doses 100, 200 and 400 groups
    Intervention: Drug: Dimethandrolone Undecanoate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2014)
100
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2011)
84
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Exclusion Criteria:

  1. Men participating in another clinical trial involving an investigational drug within the last 30 days prior to the first screening visit.
  2. Men not living in the catchment's area of the clinic or within a reasonable distance from the study site.
  3. Clinically significant abnormal physical and laboratory findings at screening.
  4. Elevated PSA (levels ≥ 2.5 ng/mL), according to local laboratory normal values.
  5. 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.
  6. Abnormal semen analyses or abnormal semen concentration as defined by the WHO semen manual.
  7. Use of androgens or other body building substances including nutritional supplements within 3 months before first screening visit.
  8. 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).
  9. Clinically significant abnormal EKG and a QTc interval of > 450 msec.
  10. PHQ-9 score of 15 or above [for the 28 days study].
  11. History of hypertension, including hypertension controlled with treatment.
  12. Known history of primary testicular disease or disorders of the hypothalamic-pituitary axis.
  13. Benign or malignant liver tumors; active liver disease.
  14. History of breast carcinoma.
  15. Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease.
  16. Known history of cardiac, renal, hepatic or prostatic disease.
  17. Positive serology for Hepatitis or HIV at screening visit.
  18. A serious systemic disease such as diabetes mellitus or obesity (body weight greater than BMI >33 kg/m2 as above).
  19. History of known, untreated sleep apnea.
  20. Known or suspected alcoholism or drug abuse that may affect metabolism/transformation of steroid hormones and study treatment compliance.
  21. Partner is known to be pregnant.
  22. Men desiring fertility within the first 24 weeks of study participation.
  23. Men participating in competitive sports where drug screening for prohibited substances (including anabolic steroids) is routine will be advised of the relative and temporary hazards that participating in this study may have for their fertility or sporting status.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01382069
Other Study ID Numbers  ICMJE CCN010
HHSN275201000080U ( Other Grant/Funding Number: NICHD Contract. This is not a grant but a contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study Sponsor  ICMJE Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • University of Washington
Investigators  ICMJE
Principal Investigator: Christina Wang, MD Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Principal Investigator: Stephanie Page, MD University of Washington
PRS Account Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP