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Phlebotomy Study of Testosterone Undecanoate

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. Identifier: NCT02670343
Recruitment Status : Completed
First Posted : February 1, 2016
Results First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Information provided by (Responsible Party):
Clarus Therapeutics, Inc.

Brief Summary:
An open-label, single oral TU dose study was conducted in eight (8) hypogonadal men at a single study site. Each study participant received a single oral TU dose immediately prior to a standardized breakfast meal comprised of 800 to 1000 calories and approximately 30 g of fat. Blood samples were collected 30 minutes prior dose administration and at 0 pre-dose and post dose at the following hours post-dose; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours.

Condition or disease Intervention/treatment Phase
Hypogonadism Drug: Oral Testosterone Undecanoate Phase 1 Phase 2

Detailed Description:
This open-label, single oral dose, phlebotomy study was designed to clarify the issue of the influence of blood collection tubes on T, DHT, TU and DHTU measurements by collecting blood samples into various collection tubes from a small number of hypogonadal men dosed with a single oral TU dose in the form of a SEDDS formulation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Blood Collection Methodology Following Administration of a Single-Dose of an Oral Testosterone Undecanoate Formulation In Hypogonadal Men
Study Start Date : January 2016
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Oral Testosterone Undecanoate
A single dose of oral testosterone undecanoate equivalent to 200 mg of testosterone in the form of two soft gelatin capsules containing 158 mg of testosterone undecanoate will be administered to each subject.
Drug: Oral Testosterone Undecanoate
Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.
Other Name: testosterone undecanoate

Primary Outcome Measures :
  1. % of Mean Difference in T Concentration Compared to Plain Collection Tube [ Time Frame: Sample collection at -0.5, and 0 hours pre-dose and post-dose samples collected at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12, hours after a single dose of oral TU. ]

    The measured outcome presented is the difference as a percent of mean of T results when comparing T Concentrations measured in three different types of NaF containing collection tubes (NaF+EDTA, NaF+Oxalate and NaF) to T measured in blood collected in plain tubes. The % of Mean Difference in T concentration for each tube type was obtained by taking the average at each time point a T concentration was obtained, and calculating the mean difference between the test ((NaF+EDTA, NaF+Oxalate and NaF) tubes and the control (plain) tube.

    The concentration of total T will be determined in the serum/plasma samples of all subjects using validated LC/MS/MS methods at the Endocrine and Metabolic Research Lab.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male, 18 to 65 years of age, inclusive, with a diagnosis of hypogonadism and a screening total serum T of < 300 ng/dL.
  2. Adequate venous access to allow blood sample collections via venous cannula.
  3. Naïve to androgen-replacement therapy or willing to temporarily cease current T treatment and willing to remain off all forms of T except for study medication throughout study.
  4. Voluntarily provide written informed consent to participate in this study.

Exclusion Criteria:

Subjects meeting any of the following exclusion criteria will not be eligible:

  1. Significant intercurrent disease (especially liver, kidney, heart disease, uncontrolled diabetes mellitus or psychiatric illness)
  2. Abnormal prostate digital rectal examination, elevated PSA (PSA > 4 ng/mL), AUA Symptom Score ≥ 15 points and/or history of prostate CA.
  3. BMI less than 18 kg/m2 or greater than 37 kg/m2
  4. Serum transaminases > 2 times upper limit of normal (ULN) or serum bilirubin >2.0 mg/dL.
  5. History of severe or multiple allergies, or severe adverse drug reaction. A known hypersensitivity to lidocaine or all surgical dressings which may be used in the study procedures.
  6. History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation.
  7. Oral, topical or buccal T therapy within previous one week, or intramuscular T injection within previous 4 weeks.
  8. Parenteral T-undecanoate therapy within the past 6 months.
  9. Use of dietary supplements that may increase serum T, within previous 4 weeks.
  10. Known malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile acid-binding resins, colestipol, fibric acid derivatives, clofibrate, gemfibrozil, and probucol.
  11. Smokers unable to refrain from smoking during required confinement period.
  12. History of, or current evidence of, abuse of alcohol or any drug substance.
  13. Receipt of any research study drug within 30 days of study.
  14. Blood donation within the 12 week period before the initial study dose.
  15. Hematocrit less than 35% or greater than 50%.
  16. History of clinically significant polycythemia following treatment with a testosterone replacement product.
  17. Current use of paroxetine, clomipramine, antiandrogens, estrogens, potent P450 enzyme inducers, or barbiturates.
  18. History of uncontrolled sleep apnea.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02670343

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United States, California
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90502
Sponsors and Collaborators
Clarus Therapeutics, Inc.
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Principal Investigator: Christina Wang, M.D. Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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Responsible Party: Clarus Therapeutics, Inc. Identifier: NCT02670343    
Other Study ID Numbers: CLAR-15013
First Posted: February 1, 2016    Key Record Dates
Results First Posted: March 9, 2018
Last Update Posted: March 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Individual participant data will be provided to each respective investigator at the end of the trial.
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents