Pivotal phase III trial to investigate the efficacy and safety of an Orodispersible Tablet vardenafil versus placebo in the treatment of men with Erectile dysfunction (ED) - a fixed-dose, double-blind, raNdomized multi-center Trial - POTENT I - POTENT I

Bayer HealthCare AG, D-51368 Leverkusen, Germany0 sites350 target enrollmentMarch 7, 2008

Overview

No summary available.

Registry

who.int

Start Date

March 7, 2008

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

Bayer HealthCare AG, D-51368 Leverkusen, Germany

•1\)Males 18 years\-of\-age or older.
•2\)Stable, heterosexual relationship for at least 6 months.
•3\)A history of erectile dysfunction (ED) for at least 6 months, defined as the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse” by the NIH Consensus Development Panel on Impotence.1
•4\)The subject must make at least four attempts at sexual intercourse on four separate days during the untreated baseline period (according to the answer to the following question in the Subject Diary: Was sexual activity initiated with the intention of intercourse?”) (to be fulfilled at visit 2\).
•5\)At least 50% of attempts at sexual intercourse during the untreated baseline period must be unsuccessful, according to the following questions from the Subject Diary (at least one question should be answered with a No”): a)Were you able to achieve at least some erection (some enlargement of the penis)?” b)Were you able to insert your penis in your partner’s vagina?” c)”Did your erection last long enough for you to have successful intercourse?” (to be fulfilled at visit 2\).
•6\)Subjects highly motivated to obtain treatment for erectile dysfunction.
•7\)Documented, 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

•1\)Any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity according to the NIH consensus report.1
•2\)History of myocardial infarction, stroke or life\-threatening arrhythmia within 6 months prior to visit 1 (\= screening).
•3\)Uncontrolled atrial fibrillation / flutter at screening (defined as ventricular response rate \= 100 bpm).
•4\)Bleeding disorder.
•5\)History of surgical prostatectomy (Note: Subjects with a history of transurethral resection of prostrate (TURP), cryosurgery, cryotherapy or cryoablation can be included in the study).
•6\)Hereditary degenerative retinal disorders such as retinitis pigmentosa.
•7\)History of loss of vision because of NAION, temporary or permanent loss of vision, including unilateral loss of vision.
•8\)Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s disease) which, in the investigator’s opinion, would significantly impair sexual performance.
•9\)Subjects who have been confirmed with phenylketonuria (PKU).
•10\)Primary hypoactive sexual desire.