EUCTR2007-001012-23-NL进行中（未招募）1 期
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
Auxilium UK Limited0 个研究点目标入组 0 人开始时间: 2007年4月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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
排除标准
- •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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