The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease

NCT00755222 | Completed Phase 2 Results

• 1 other identifier: AUX-CC-801
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 12

Brief Summary

This study evaluated the safety and effectiveness of AA4500 in improving the impact of Peyronie's disease on quality of life and improving penile curvature in men with Peyronie's disease

Conditions

Peyronie's Disease

Keywords

Peyronie's disease; penile plaque; penile curvature

Outcome Measures

Primary Outcomes (5)

• Change From Baseline in Penile Curvature

  Negative change reflects improvement in penile curvature

  Baseline and Week 36 or last observation carried forward (LOCF)

• Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie's Disease Symptom Bother

  Peyronie's disease Symptom Bother Scale: 0-20 lower numbers reflect 'less symptom bother'; higher numbers reflect 'more symptom bother' Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the symptom bother scale.

  Baseline to Week 36 or LOCF

• Change From Baseline in PDQ Intercourse Contraint

  Peyronie's disease intercourse contraint Scale: 0-12 lower numbers reflect 'less intercourse contraint'; higher numbers reflect 'more intercourse constraint' Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse constraint scale.

  Baseline to Week 36 or LOCF

• Change From Baseline in PDQ Intercourse Discomfort

  Peyronie's disease intercourse discomfort Scale: 0-15 lower numbers reflect 'less intercourse discomfort'; higher numbers reflect 'more intercourse discomfort' Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse discomfort scale.

  Baseline to Week 36 or LOCF

• Change From Baseline in PDQ Penile Pain

  Peyronie's disease penile pain Scale: 0-40 lower numbers reflect 'less penile pain'; higher numbers reflect 'more penile pain' Change from baseline=Week 36 minus baseline. Negative change reflects improvement in the penile pain scale.

  Baseline to Week 36 or LOCF

Study Arms (2)

AA4500

EXPERIMENTAL

Clostridial collagenase for injection

Biological: AA4500

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

AA4500 BIOLOGICAL

2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series was separated by 6 weeks.

Also known as: Clostridial collagenase for injection (AA4500)

AA4500

Placebo BIOLOGICAL

2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series is separated by 6 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heterosexual male ≥ 18 years of age
• In a stable relationship with a partner/spouse for at least 3 months before screening
• Have a diagnosis of Peyronie's disease for at least 6 months before first dose of study drug
• Have a penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane
• Have functional difficulty related to Peyronie's disease (eg, difficulty with intromission or erectile dysfunction)
• Be judged to be in good health based upon the results of medical history, physical examination and laboratory profile
• Voluntarily sign an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must have also signed an authorization form to allow disclosure of his protected health information. The protected health information authorization form and informed consent form may have been an integrated form or may have been separate forms, depending on the institution
• Be able to complete and understand the various rating instruments

You may not qualify if:

• Have had an average of three successive blood pressure readings ≥ 160/100 mmHg during screening or the Day 1 assessments
• Severe pain during penile palpation
• Any of the following conditions:
• Chordee in the presence or absence of hypospadias
• Thrombosis of the dorsal penile artery
• 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 sexually transmitted disease
• Known Hepatitis B or C
• Known immune deficiency disease or be positive for human immunodeficiency virus (HIV)
• Previously undergone surgery for Peyronie's disease
• Penile curvature of less than 30° or greater than 90°
• Failed to have a rigid erection after pharmacological stimulation with a vasoactive injection of Prostaglandin E1 10 to 20 µg, which, in the opinion of the investigator, was sufficient to accurately measure the subject's penile deformity
• Had an isolated hourglass deformity of the penis without curvature

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (12)

Urology Associates Medical Group

Burbank, California, 91505, United States

Location

Urology Specialists Connecticut Clinical Research Center, LLC

Middlebury, Connecticut, 06762, United States

Location

The Urology Center, PC

New Haven, Connecticut, 06511, United States

Location

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Urology Specialists, SC

Chicago, Illinois, 60612, United States

Location

Northeast Indiana Research, LLC

Fort Wayne, Indiana, 46825, United States

Location

Metropolitan Urology, PSC

Jeffersonville, Indiana, 47130, United States

Location

Maimonides Medical Center Divison of Urology

Brooklyn, New York, 11219, United States

Location

University Urology Associates

New York, New York, 10016, United States

Location

Tristate Urologic Services

Cincinnati, Ohio, 45212, United States

Location

Baylor College of Medicine, Scott Department of Urology

Houston, Texas, 77030, United States

Location

Urology of Virginia (a division of Sentara Medical Group)

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Penile Induration

Interventions

Injections

Condition Hierarchy (Ancestors)

Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals, Inc.

clinicalsite.inquiries@endo.com

Study Officials

• Veronica Urdaneta, MD

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 18, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 5, 2017
• Results First Posted: April 26, 2011

Record last verified: 2017-09

Locations

US (12)