Peyronie's Disease
Conditions
Sponsors
Endo Ventures Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: No subject will be enrolled until all eligibility criteria have been satisfied. To qualify for the study a subject must: 1. Be a male =18 years of age 2. Have symptom(s) of Peyronie's disease and have evidence of stable disease as determined by the investigator 3. Have penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane at screening. It must be possible to delineate the single plane of maximal curvature for evaluation during the study 4. Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile 5. Voluntarily sign and date an informed consent agreement approved by the Independent Ethics Committee (IEC). 6. Be able to read, complete and understand the various rating instruments in English. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: A subject will be excluded from study participation if he: 1. Has a penile curvature of less than 30° or greater than 90° at the screening visit 2. Has any of the following conditions: - Chordee in the presence or absence of hypospadias - Thrombosis of the dorsal penile artery and/or vein - Infiltration by a benign or malignant mass resulting in penile curvature - Infiltration by an infectious agent, such as lymphogranuloma venereum - Ventral curvature from any cause - Presence of an active sexually transmitted disease - Known active hepatitis B or C - Known immune deficiency disease or be positive for human immunodeficiency virus (HIV) 3. Has a history of spontaneous priapism (ie, erection that lasts more than four hours) 4. Has previously undergone surgery for Peyronie’s disease 5. Fails to have an erection which, in the opinion of the investigator, is sufficient to accurately measure the subject’s penile deformity after administration of prostaglandin E1 6. Has a calcified plaque as evident by appropriate radiographic evaluation, penile ultrasound that would prevent proper injection of study medication. Non-contiguous stippling of calcium is acceptable for inclusion provided the calcium deposit does not interfere with the injection of AA4500 into the plaque 7. Has an isolated hourglass deformity of the penis 8. Has the plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anesthetic would interfere with the injection of AA4500 into the plaque 9. Has previously received alternative medical therapies for Peyronie’s disease administered by the intralesional route (including, but not limited to, steroids, verapamil, and the naturally occurring low molecular weight protein, interferon-a2b) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study 10. Has received alternative medical therapies for Peyronie’s disease administered by the oral (including, but not limited to, vitamin E [>500 U], potassium aminobenzoate [Potaba], tamoxifen, colchicine, pentoxifylline, over-the-counter erectile dysfunction medications, or steroidal anti-inflammatory drugs) or topical routes (including, but not limited to, verapamil applied as a cream) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study 11. Has had extracorporeal shock wave therapy (ESWT) for the correction of Peyronie’s disease within the 6-month period before screening or plans to have ESWT at any time during the study 12. Has used any mechanical type device for correction of Peyronie’s disease within the 2-week period before screening or plans to use any these devices (except for that prescribed by protocol) at any time during the study 13. Has used a mechanical device to induce a passive erection within the 2-week period before screening or plans to use any of these devices (except for that prescribed by protocol) at any time during the study 14. Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors 15. Has a penile Duplex Doppler ultrasound evaluation at screening that shows compromised penile hemodynamics that in the opinion of the investigator is clinically significant 16. Has uncontrolled hypertension, as determined by the investigator 17. Has a known
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are to assess the safety and effectiveness of AA4500 in combination with the ErecAid® Esteem® Manual Vacuum Therapy System in improving curvature deformity in men with Peyronie’s disease.;Secondary Objective: The secondary objectives will be captured as a change from baseline in the Peyronie’s disease bother domain (PDQ questions 10-15), the change from baseline in severity of Peyronie’s disease physical and psychological symptom domain (PDQ questions 1-6), the change from baseline in the penile pain domain (PDQ questions 7-9), the responder analysis based on subject global assessment, the change from baseline in overall satisfaction domain of the IIEF, the change from baseline in penile plaque consistency, and the change from baseline in penile length will be summarized with descriptive statistics at each evaluation window;Primary end point(s): The percent improvement from baseline in penile curvature to be summarized with descriptive statistics at each evaluation window.;Timepoint(s) of evaluation of this end point: Day 42, 84, 126, 168 and 252. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: - Change in Peyronie’s disease bother, psychological and physical symptoms of Peyronie’s disease, and penile pain: Day 168 and 252. - A responder analysis based on subject global assessment: Day 168 and 252. - Change in penile plaque consistency: Day 1, 42, 84, 126, 168 and 252. - Change in penile length: Day 42, 84, 126, 168 and 252.;Secondary end point(s): Secondary endpoint analyses are: - Change in Peyronie’s disease bother, psychological and physical symptoms of Peyronie’s disease, and penile pain - A responder analysis based on subject global assessment - Change in penile plaque consistency - Change in penile length | — |
Countries
United Kingdom
Contacts
Public ContactDirector, Regulatory Affairs
Endo Ventures Limited
Outcome results
None listed