EUCTR2005-003971-19-GB进行中（未招募）1 期
Clinical study to evaluate the ability of Muse to increase erectile function in post-radical prostatectomy patients. - Not Available
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
- Meda AB
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
- •To be eligible for this study the patient must:
- •1. be an adult male less than 70 years of age;
- •2. have had normal erectile function, defined by a pre surgery erectile function domain of > 26 prior to surgery;
- •3. have undergone a bilateral nerve-sparing radical retro pubic prostatectomy for prostate cancer;
- •4. have post surgery ED, as determined by an IIEF score of < 26;
- •5. be willing and able to self-administer MUSE or Viagra three times a week for 9 months or until there is evidence of spontaneous erectile function;
- •6. be in a stable, monogamous heterosexual relationship;
- •7. provide written informed consent;
- •8. be willing and able to comply with all study requirements, visit schedules and procedures.
- •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
- •The patient will be excluded who:
- •1. has a tumour Gleason score equal to or greater than 8 or a prostate specific antigen (PSA) score equal to or greater than 20ng/ml;
- •2. requires post surgical radiation therapy or androgen ablation;
- •3. has a known allergy to alprostadil or any of the components of the formulation or to Viagra or any of the components of the formulation;
- •4. has used an investigational drug within the past 30 days or previously been enrolled in this study;
- •5. participated in another trial within the past 6 weeks or currently participates in another trial;
- •6. requires nitrates, or has a history of cardiac failure or coronary artery disease causing unstable angina or congestive heart failure that has required medical intervention and treatment;
- •7. has a history of chronic blood pressure less than 90/50 or greater than 170/100 mmHg;
- •8. is taking alpha blockers as antihypertensive medication;
- •9. has a concomitant treatment with CYP3A4-inhibitory drugs;
- •10. has been treated with locally administered Alprostadil (e.g. MUSE) or phosphodiesterase inhibitors (e.g. Viagra) within 30 days before study start or will concomitantly be treated with other locally administered Alprostadil or phosphodiesterase inhibitors besides study medication;
- •11. has had a stroke, myocardial infarction or life-threatening arrhythmia within the past six months;
- •12. has hepatic or severe renal failure;
- •13. has retinitis pigmentosum;
- •14. has abnormal penile anatomy (stenosis of the distal urethra, severe hypospadia or severe curvature), balanitis, acute or chronic urethritis
- •15. has conditions with an increased risk of priapism (sickle cell anaemia or trait, thrombocythaemia, polycythaemia, multiple myeloma, predisposition to venous thrombosis), or a history of recurrent priapism
- •16. has a significant medical problem such as an unstable cardiovascular or cerebrovascular condition which, in the opinion of the investigator, would preclude the administration of study medications, interfere with study evaluations, limit study participation, or otherwise contraindicate sexual activity;
- •17. has an abnormal ECG that the investigator deems to be clinically significant. The ECG should be maximum three months old.
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