E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects will be hypogonadal men with an 0800 hr (±30 minutes) serum testosterone level ≤ 350 ng/dL |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10021011 |
E.1.2 | Term | Hypogonadism male |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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).
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | Yes |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study is defined as when the final subject completes the final Day 15 follow-up visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |