EUCTR2005-001678-28-DE进行中（未招募）不适用
A randomized, explorative, double-blind, double-dummy, multi-center, parallel group study to assess sustainable efficacy of once daily vardenafil (10 mg) for 12 and 24 weeks versus vardenafil PRN in men with mild or mild to moderate erectile dysfunction - RESTORE
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 267
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
- •Males 18-64 years of age
- •Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
- •History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
- •Stable, heterosexual relationship for more than six months
- •Documented, signed and dated written Informed Consent
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A) Previous or Current Medical Conditions
- •Any unstable medical, psychiatric, or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study
- •Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s disease) in the opinion of the Investigator would significantly impair sexual performance
- •Primary hypoactive sexual desire
- •Spinal cord injury
- •History of glaucoma
- •History of surgical prostatectomy (transurethral intervention not excluded)
- •Hereditary degenerative retinal disorders such as retinitis pigmentosa
- •History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C
- •Known severe chronic or acute liver disease, including history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment
- •Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia
- •Clinically significant bleeding disorder
- •Significant active peptic ulceration
- •Any underlying cardiovascular condition including e.g. unstable angina pectoris or ventricular failure NYHA stages III or IV, that would preclude sexual activity; symptomatic angina pectoris
- •History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months
- •Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 100 bpm)
- •Resting hypotension (a resting systolic blood pressure of <90 mm Hg or diastolic blood pressure of < 50 mmHg)
- •Insufficiently controlled hypertension: In patients known to be hypertensive, hypertension has to be sufficiently controlled with antihypertensives in the opinion of the physician treating the hypertension. In addtion, resting blood pressure at visit 1 (singular measurement not appropriate to judge on control of hypertension) must not be >170 mmHg (systolic) or > 110 mmHg (diastolic) irrespective of a patient having been classified as hypertensive or not.
- •Symptomatic postural hypotension within six months of Visit 1
- •History of malignancy within the past 5 years (other than squamous or basal cell skin cancer)
- •Life expectancy <3 years
- •Clinical diagnosis of significant untreated sleep apnea or working night shifts (e.g. 23:00h to 7:00 h).
- •Diabetes mellitus type 1
- •B) Concomitant Medication
- •Nitrates or nitric oxide donors
- •Oral or injectable or transdermally applied androgens
- •Anti-androgens
- •Anti-coagulants, with the exception of anti-platelet agents
- •Any of the following potent inhibitors of cytochrome P- 450 3A4:
- •potent inhibitors: HIV protease inhibitors (indinavir, nelfinavir, ritonavir, atazanavir, lopinavir, amprenavir, saquinavir), makrolid/-ketolid antibiotics (clarithromycin, erythromycin, telithromycin), anti-mycotic agents (itraconazole, ketoconazole [topical forms are allowed]), anti-depressants (nefazodon)
- •less potent inhibitors: quinupristin/-dalfupristin, fluconazol, amiodaron, diltiazem, fluvoxamin, verapamil, valproinic acid, fluoxetin; grapefruit juice
- •Any investigational drug (including placebo) within 30 days of Visit 1
- •Any treatment for ED other than study medication during the study, including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories
- •Alpha blockers during randomised treatment and wash-out.
- •C) Abnormal Laboratory Values
- •Serum total testosterone level >25% below the lower limit of normal (according to the range of the testing
研究者
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