A Randomized, Double-Blind, Two-Way Crossover Study to Determine the Bioequivalence of a Single Dose of Testim® 1% With Pentadecalactone 1% Relative to a Single Dose of Testim® 1% With Pentadecalactone 8% in Hypogonadal Males

Phase 1

• Conditions: Subjects will be hypogonadal men with an 0800 hr (±30 minutes) serum testosterone level = 350 ng/dL; MedDRA version: 9.1Level: LLTClassification code 10021011Term: Hypogonadism male

• Registration Number: EUCTR2007-001012-23-NL
• Lead Sponsor: Auxilium UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-17
• Study Completion: 2007-06-07
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified