Estudio aleatorizado, doble ciego, enmascarado, multicéntrico, controlado con placebo, de grupos paralelos para comparar la seguridad y la eficacia de vardenafilo tomado una vez al día frente al tratamiento a libre demanda para mejorar la función eréctil en varones inmediatamente después de haber sido sometidos a una prostatectomía radical con preservación nerviosa bilateral. - REINVENT (Recovery of Erection: Intervention with Vardenafil Early Nightly Therapy

Phase 1

• Conditions: Disfunción Eréctil Erectile Dysfunction; Classification code 10061461

• Registration Number: EUCTR2004-002172-42-ES
• Lead Sponsor: Bayer Healthcare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-09
• Study Completion: 2007-09-26
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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 T2c
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

Exclusion Criteria

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 Excl

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified