ong-term study of safety, curvature and presence of antibodies in men previously treated with AA4500 for Peyronie's Disease

Phase 1

• Conditions: Peyronie's Disease; MedDRA version: 19.0 Level: LLT Classification code 10034766 Term: Peyronies disease System Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 19.0 Level: PT Classification code 10034765 Term: Peyronie's disease System Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2014-004239-37-GB
• Lead Sponsor: Endo Ventures Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-17
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 750

Inclusion Criteria

To be eligible for this study a subject had to:
1. Have received at least one injection of AA4500 and completed at least the first or last follow-up visit in one of the Auxilium-sponsored studies (AUX-CC-802, AUX-CC-803, AUX-CC-804, orAUX-CC-806).
2. Be able and willing to comply with the follow-up assessments outlined in the protocol, as determined by the investigator.
3. Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board / Independent Ethics Committee (IRB / IEC).

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 638
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112

Exclusion Criteria

None

Study & Design

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