Pilot Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men
Phase IIa, Pilot, Pharmacokinetic Study of Oral Testosterone Ester Formulations in Hypogonadal Men
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90502
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
-
-
Texas
-
San Antonio, Texas, United States, 78229
- dgd Research, Inc
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Male, ages 18 to 65 Serum total testosterone less than or equal to 250 ng/dL Naive to androgen replacement therapy Subject must be on stable doses of thyroid or adrenal replacement hormones for at least 14 days prior to enrollment
Exclusion Criteria:
Significant intercurrent disease of any type, in particular, liver, kidney or heart disease, uncontrolled diabetes mellitus or psychiatric illness. Patients with treated hyperlipidemia will not be excluded provided they have been stable on their lipid-lowering mediation for at least three months. For non-insulin dependent diabetic subjects, HbA1c>9%.
Abnormal prostate digital rectal examination, elevated PSA (serum PSA >4ng/mL), AUA Sympton Score greater than or equal to 15 points, and a history or prostate cancer.
Serum transaminases >2X upper limit of normal (ULN) or serum bilirubin >2.0 mg/dL.
History of severe or multiple allergies, severe adverse drug reaction or leucopenia. Known hypersensitivity to lidocaine or all surgical dressings.
History of abnormal bleeding tendencies. Oral, topical, or buccal T therapy within the previous week, or intramuscular T injection within the previous 4 week.
Use of dietary supplements that may increase serum T, such as androstenedione or DHEA, within the previous 4 weeks.
Know malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile acid-binding resins, colestipol, fibric acid derivatives, gemfibrozil, and probucol.
Smokers who are unable to refrain from smoking during confinement periods. History of, or current evidence of, abuse of alcohol or any drug substance. Poor compliers or those unlikely to attend. Receipt of any drug as part of a research study within 30 days of inital dose administration in this study.
Blood donation (usually 550 mL) within the 12-week period before the initial study dose.
Hematocrit less than 35%. Known clinical polycythemia or hematocrit greater than 50%. Current use of paroxetine and clomipramine, antiandrogens, estrogens, p450 enzyme inducers, or barbiturates.
History of sleep apnea.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Testosterone undecanoate
Period 2 - 200 mg T (as TU) QD Period 3 - 200 mg T (as TU) BID (100 mg/dose) Period 4 - 400 mg T (as TU) BID (200 mg/dose)
|
Single-day dose as QD or BID for 3 of 5 crossover periods
Other Names:
|
|
Active Comparator: Testosterone enanthate
Period 1 - 400 mg T (as TE) QD Period 5 - 800 mg T (as TE) BID (400 mg/dose)
|
Single-day dose for 2 of 5 crossover periods
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Serum Testosterone Cavg
Time Frame: Concentrations at -0.5, 0, 1, 2, 4, 8, 12, 13, 14, 16, 20, 24 and 34 hours post dose
|
The objective of the study was to determine the single day serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU formulation) administered once- and twice-daily to hypogonadal men.
|
Concentrations at -0.5, 0, 1, 2, 4, 8, 12, 13, 14, 16, 20, 24 and 34 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Serum Dihydrotestosterone Cmax
Time Frame: 24 hours post-dose in each period
|
The objective of the study was to determine the single day serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU formulation) administered once- and twice-daily to hypogonadal men.
|
24 hours post-dose in each period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ronald S Swerdloff, MD, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Principal Investigator: Sherwyn Schwartz, MD, DGD Research, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Gonadal Disorders
- Hypogonadism
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Androgens
- Anabolic Agents
- Testosterone
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- CLAR-07004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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