EUCTR2005-003971-19-DE进行中（未招募）不适用
Clinical study to evaluate the ability of MUSE to increase erectile function in post-radical prostatectomy patients - Randomised, controlled, open study with two parallel groups comparing MUSE 250 µg to Viagra 50 mg over a treatment period of 9 months
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- MEDA AB
- 入组人数
- 60
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 the study the patient must:
- •1. be an adult males less than 70 years of age;
- •2. have had normal erectile function, defined by a pre surgery score on the IIEF 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 tumor Gleason score equal to or greater than 8 or a prostate specific antigen (PSA) score equal to or greater than 20 ng/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, thrombocythmaemia, 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.
研究者
相似试验
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 AvailableErectile DysfunctionEUCTR2005-003971-19-GBMeda AB
尚未招募
2 期
TO SEE THE EFFECT OF MUSTAK AND VACHA IN OBESITYCTRI/2022/10/046268ttarakhand Ayurved University
招募中
不适用
Intervention of Haritakyadi kwath in the management of urinary tract infectioCTRI/2021/06/034369RGGPG Principal RGG PG Ayu Ayurvedic College and Hospital Paprola
招募中
4 期
Effectiveness of the Homoeopathic Medicine Ipecac in Chronic CoughCTRI/2024/01/062140VINAYAKA MISSION HOMOEOPATHY MEDICAL COLLEGE AND HOSPITA
已完成
2 期
Efficacy of role playing in reduce anxietyManagement of anxiety during dental treatment.Phobic anxiety disorder of childhoodIRCT2016011217935N6Vice Chancellor for Research of Shahid Sadoughi University of Medical Sciences of Yazd40