Subjects will be hypogonadal men with an 0800 hr (±30 minutes) serum testosterone level = 350 ng/dL MedDRA version: 9.1 Level: LLT Classification code 10021011 Term: Hypogonadism male
Conditions
Interventions
Product Name: Testim 50 mg Gel, CPD 1%
Product Code: AA2500 CPD 1%
Pharmaceutical Form: Gel
INN or Proposed INN: testosterone
Current Sponsor code: AA2500 1% CPD
Concentration unit: mg milligram(s)
Co
Sponsors
Auxilium UK Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Subject is male between 18 and 80 years of age. 2. Subject has an 0800 hr (±30 minutes) serum testosterone level = 350 ng/dL. 3. Subject’s body mass index is = 39 (see Appendix C). 4. Subject is judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile. 5. Subject voluntarily signs and dates an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject has any skin irritation or disease that might interfere with absorption of study drug or skin irration asssessment, including eczema, psoriasis, melanoma, or acne. 2. Subject has a history of a significant systemic allergy or a drug hypersensitivity to any component of the testosterone medication used in this study. 3. Subject has been treated with a testosterone ester injection within 6 weeks before the first dose of study drug or an oral or a transdermal androgen within 4 weeks before the first dose of study drug. 4. Subject has taken supplements within 4 weeks before the first dose of study drug that are assumed to be anabolic (eg, dehydroepiandrosterone [DHEA] and creatine). 5. Subject is receiving medications that may interfere with androgen metabolism (eg, spironolactone, finasteride, or ketoconazole). 6. Subject has serum prostate specific antigen (PSA) level = 4 ng/mL and/or an IPSS = 15. 7. Subject has diagnosed prostate cancer or a history, thereof, or palpable prostatic masses for which a workup has not ruled out prostate cancer. 8. Subject has diagnosed breast cancer or a history of breast cancer. 9. Subject has benign prostatic hypertrophy and is at risk for urinary obstruction, in the opinion of the investigator. 10. Subject has a hemoglobin, hematocrit, or red blood cell count greater than or equal to the upper limit of the laboratory’s normal range. 11. Subject has any liver function test = 1.5 times the upper limit of normal. 12. Subject has a history of illicit drug abuse. 13. Subject has self-reported suicidal ideations, thoughts, attempts or prior attempts. 14. Subject has a self-reported history of depression. 15. Subject has unstable cardiovascular disease as determined by the investigator. 16. Subject has a history of recent stroke (cerebrovascular event). 17. Subject has developed hyperparathyroidism or renal dysfunction. 18. Subject has developed sleep apnea that in the investigator’s opinion places the subject at risk with treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the pharmacokinetics and safety of Testim 50 mg (1%) with 1% CPD (cyclopentadecanolide;pentadecalactone; oxacyclohexadecan-2-one) relative to Testim 50mg (1%) with 8% CPD in hypogonadal men. ;Secondary Objective: ;Primary end point(s): A measured drug concentration for testosterone, DHT, and free testosterone versus time curve will be produced in graphic and tabular form, for each subject on both linear and log scales. Mean drug concentration versus time curves will also be presented for each treatment separately. Summary statistics (ie, N, mean, standard deviation, minimum, maximum, and coefficient of variation) will be calculated for serum concentration for each time point and each treatment. Pharmacokinetic parameter values will be estimated using validated pharmacokinetic software. A non-compartmental approach will be used to generate parameters estimates. The following pharmacokinetic parameter estimates for testosterone, DHT, and free testosterone will be calculated: • Maximum observed concentration (Cmax) will be determined by direct inspection of the serum drug concentration versus time data point values • Time to maximum observed concentration (Tmax) will be determined by direct inspection of the serum drug concentration versus time data point values • Area under the concentration-time curve (AUC) for 24 hours will be estimated using linear or linear/log trapezoidal calculations | — |
Countries
Netherlands
Outcome results
None listed