A randomized, double-blind, double-dummy, multicenter, parallel group study to compare the tolerability and efficacy of once daily vardenafil versus vardenafil PRN versus placebo in men immediately after nerve-sparing prostatectomy for improving erectile function - REINVENT (Recovery of Erection: Intervention with Vardenafil Early Nightly Therapy)
- Conditions
- Erectile DysfunctionMedDRA version: 8.1Level: LLTClassification code 10061461Term: Erectile dysfunction
- Registration Number
- EUCTR2004-002172-42-GB
- Lead Sponsor
- Bayer Healthcare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 0
At Screening: Males 18-64 years of age Scheduled to undergo bilateral nerve-sparing radical retropubic BNSRRP, as selected according to the investigator’s usual clinical practice Surgery scheduled within about 1 month of screening (Visit 1) Expressed an interest in resuming sexual activity as soon as possible after prostatectomy Heterosexual relationship. No pre-operative erectile dysfunction: International Index of Erectile Function (IIEF) Erectile Function Domain Score score EF domain =26 at screening (Visit 1) without any therapy/devices for improvement of erections. No previous use of any therapy/devices for erectile dysfunction Historical total prostate specific antigen (PSA) <10 ng/mL Gleason Tumor Score = 7 on biopsy No perforation of the prostate capsule by tumor: Clinical stage pre-operatively T1c to T2a/2b Documented, signed and dated written Informed Consent At Randomization: Bilateral nerve-sparing during the retropubic prostatectomy documented on the operating report BNSRRP occurred within approximately 1 month post screening (Visit 1) No perforation of the prostate capsule by tumor: No positive tumor margins confirmed after surgery: =T2 stage on pathology report from the surgery
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
At Screening: 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 Hereditary degenerative retinal disorders such as retinitis pigmentosa History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C 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 Bleeding disorder Significant active peptic ulceration Any underlying cardiovascular condition (such as unstable angina pectoris or severe heart failure New York Heart Association class III or IV) including unstable angina pectoris that would preclude sexual activity 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 <50 mmg Hg) or hypertension (a resting systolic blood pressure >170 mm Hg or a resting diastolic blood pressure >110 mm Hg) Symptomatic postural hypotension within 6 months of Visit 1 History of malignancy within the past 5 years (other than prostate cancer or 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 I, type II with presence of end organ symptomatology (e.g. peripheral neuropathy, nephropathy, retinopathy, amyotrophy) B) Concomitant Medication: Nitrates or nitric oxide donors Oral or injectable androgens Anti-androgens Any of the following potent inhibitors of cytochrome P- 450 3A4: HIV protease inhibitors such as ritonavir or indinavir; anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed); or erythromycin Any investigational drug (including placebo) within 30 days of Visit 1 Any treatment for ED historically or during the study, including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories Alpha blockers (unless they can be discontinued by one week before randomisation) 5-alpha-reductase inhibitors C) Abnormal Laboratory Values: Serum total testosterone level >25% below the lower limit of normal (according to the range of the testing laboratory). Serum creatinine > 3.0 mg/dL. Elevation of AST and/or ALT >3X the ULN D) Other Exclusions: Known hypersensitivity to vardenafil, Bay 38-9456 (also known as SB-782528) or any component of the investigational medication Illiterate or are unable to understand the questionnaires or subject diary Unwilling or unable to complete the subject diary or questionnaires At Randomization: Residual prostate cancer, or requirement for radiotherapy or ADT Need for a re-exploration surgery due to hemorrhage Need for urethral catheter expected to be =3 weeks due to anastomotic fistula
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method