Safety and Efficacy of AA4500 in combination with Erecaid Esteem Manual Vacuum Therapy System in men with Peyronie's Disease
- Conditions
- Peyronie's DiseaseTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2013-005384-66-GB
- Lead Sponsor
- Endo Ventures Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 30
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
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
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