EUCTR2004-004891-36-ES进行中（未招募）1 期
CROSS-OVER COMPARISON OF TESTOSTERONE SERUM LEVELS IN HYPOGONADAL MEN TREATED WITH L0074 TESTOSTERONE PATCH 60CM2 (2 patches/48H) AND ORAL TESTOSTERONE UNDECANOATE -PANTESTONE® 40mg- (2 caps, bid) - NA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 55
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
- •?Men aged > 18 years with known primary or secondary hypogonadism previously treated or not with androgens
- •?Serum TT level lower or equal to 2.5 ng/mL (after androgen washout for previously treated patients)
- •?BMI lower or equal to 32 kg/m2
- •?Patients having signed a written informed consent,
- •?Well-informed of the study procedures, cooperative with regard to compliance with study related constraints,
- •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
- •*Criteria related to pathologies
- •?Known acute or chronic prostate pathology, and/or PSA > 2 ng/mL, and/or suspicion of prostate cancer; familial history of prostate cancer,
- •?Male breast cancer,
- •?Severe cardiovascular, respiratory, hepatic, renal failure, or metabolic diseases/disorders,
- •? Non stabilized hypertension (> 160/90 mm Hg),
- •?Generalized dermatological disorders that might affect testosterone absorption or local tolerability assessment (hirsutism, psoriasis, eczema),
- •?ALT and/or AST twice above the upper limit; Hematocrit > 51%,
- •?Unbalanced diabetic patients (type I or II),
- •?Psychiatric disease,
- •?Organic cerebral disease (epilepsy, migraine),
- •?Sleep apnea,
- •?History of allergy to patches.
- •* Criteria related to treatments
- •?Other concomitant patch treatment or other androgen replacement therapy,
- •?Concomitant treatment with barbiturates, ketoconazole, spironolactone, oral anticoagulants, finasteride, anti-androgens, LH-RH analogues, treatment influencing erection or testosterone level, and with any other medication known to alter the cytochrome P450 enzyme systems,
- •?Corticosteroids when used topically or as immunosuppresors (they are authorized when used in physiological doses as replacement therapy in secondary adrenal insufficiency. e.g cortisol < 30 mg or prednisone < 5 mg).
- •* Criteria related to the way of life
- •?History of alcohol or drug abuse.
研究者
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