A clinical study to assess the safety and effectiveness of AA4500 in thetreatment of men with Peyronie's disease

Conditions: Peyronie's Disease
MedDRA version: 14.0Level: PTClassification code 10034765Term: Peyronie's diseaseSystem Organ Class: 10038604 - Reproductive system and breast disorders
Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Registration Number: EUCTR2010-022921-13-SE

Lead Sponsor: Auxilium UK Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 300

Inclusion Criteria

No subject should be enrolled until all eligibility criteria have been satisfied. Subjects who receive placebo in a previous Auxilium-sponsored study may enroll in this study provided they continue to meet the eligibility requirements. To qualify for the study a subject must:
1.Be a male and be = 18 years of age
2.Be in a stable relationship with a female partner/spouse for at least 3 months before screening and be willing to have vaginal intercourse with that partner/spouse
3.Have symptom(s) of Peyronie’s disease for at least 12 months before the first dose of study drug and have evidence of stable disease as determined by the investigator
4.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
5.Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile
6.Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution
7.Be able to read, complete and understand the various rating instruments in English or the appropriate local language for the country in which the study is being performed.

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 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 7

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 previously undergone surgery for Peyronie’s disease
4.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 or trimix
5.Has a calcified plaque as evident by appropriate radiographic evaluation, penile x-ray or 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
6.Has an isolated hourglass deformity of the penis
7.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
8.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
9.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

10.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
11.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 at any time during the study
12.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 at any time during the study
13.Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors
14.Has a penile Duplex Doppler ultrasound evaluation at screening that shows compromised penile hemodynamics that in the opinion of the investigator is clinically significant
15.Has uncontrolled hypertension, as determined by the investigator
16.Has a known recent history of stroke, bleeding, or other significant medical condition, which in the investigator’s opinion would make the subject unsuitable for enr