Phase 2
N=8
Phlebotomy Study of Testosterone Undecanoate
Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT02670343 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: % of Mean Difference in T Concentration Compared to Plain Collection Tube — 8.6; 16.6; 23.2 Difference as % of Mean of T results
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oral Testosterone Undecanoate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Clarus Therapeutics, Inc.
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % of Mean Difference in T Concentration Compared to Plain Collection Tube |
8.6; 16.6; 23.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male, 18 to 65 years of age, inclusive, with a diagnosis of hypogonadism and a screening total serum T of 4 ng/mL), AUA Symptom Score ≥ 15 points and/or history of prostate CA.
- BMI less than 18 kg/m2 or greater than 37 kg/m2
- Serum transaminases > 2 times upper limit of normal (ULN) or serum bilirubin >2.0 mg/dL.
- 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.
- History of abnormal bleeding tendencies or thrombophlebitis unrelated to venipuncture or intravenous cannulation.
- Oral, topical or buccal T therapy within previous one week, or intramuscular T injection within previous 4 weeks.
- Parenteral T-undecanoate therapy within the past 6 months.
- Use of dietary supplements that may increase serum T, within previous 4 weeks.
- Known malabsorption syndrome and/or current treatment with oral lipase inhibitors, bile acid-binding resins, colestipol, fibric acid derivatives, clofibrate, gemfibrozil, and probucol.
- Smokers unable to refrain from smoking during required confinement period.
- History of, or current evidence of, abuse of alcohol or any drug substance.
- Receipt of any research study drug within 30 days of study.
- Blood donation within the 12 week period before the initial study dose.
- Hematocrit less than 35% or greater than 50%.
- History of clinically significant polycythemia following treatment with a testosterone replacement product.
- Current use of paroxetine, clomipramine, antiandrogens, estrogens, potent P450 enzyme inducers, or barbiturates.
- History of uncontrolled sleep apnea.
Data sourced from ClinicalTrials.gov (NCT02670343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.