Peyronie's DiseasePhase 2NCT00755222
The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease
A Phase 2 study testing AA4500 in people with Peyronie's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 12 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronie's Disease
- What is being tested?
- AA4500
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 12 sitesUnited States
- Study dates
- Aug 2008to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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 a calcified plaque as evident by appropriate radiographic evaluation, penile x-ray, or penile ultrasound. Non-contiguous stippling of calcium was acceptable for inclusion
- Had an isolated hourglass deformity of the penis without curvature
- Had the plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anesthetic would have interfered with the injection of AA4500 into the plaque
- 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-α2b) 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
- Received alternative medical therapies for Peyronie's disease administered by the oral (including, but not limited to, vitamin E (>500IU), 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 4 weeks before the first dose of study drug or plans to use any of these medical therapies at any time during the study
- 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
- 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
- Significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors
- Recent history of stroke, bleeding, or other medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study
- Unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits
- Received an investigational drug or treatment within 30 days before the first dose of study drug
- Allergy to collagenase or any other excipient of AA4500
- Allergy to any concomitant medication required as per the protocol
- Received anticoagulant medication (except for ≤ 165 mg aspirin daily or ≤ 800 mg of over-the-counter NSAIDS daily) during the 7 days before each dose of study drug
- Received doxycycline or a tetracycline derivative during the 7 days before each dose of study drug or plans to use these drugs within 2 days after the injection of study drug
- Received any collagenase treatments within 30 days of the first dose of study drug
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
South Florida Medical Research
Aventura, Florida, 33180
Maimonides Medical Center Divison of Urology
Brooklyn, New York, 11219
Urology Associates Medical Group
Burbank, California, 91505
Urology Specialists, SC
Chicago, Illinois, 60612
Tristate Urologic Services
Cincinnati, Ohio, 45212
Northeast Indiana Research, LLC
Fort Wayne, Indiana, 46825
Baylor College of Medicine, Scott Department of Urology
Houston, Texas, 77030
Metropolitan Urology, PSC
Jeffersonville, Indiana, 47130
Urology Specialists Connecticut Clinical Research Center, LLC
Middlebury, Connecticut, 06762
The Urology Center, PC
New Haven, Connecticut, 06511
University Urology Associates
New York, New York, 10016
Urology of Virginia (a division of Sentara Medical Group)
Norfolk, Virginia, 23502
About this study
Official title: A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effectiveness of AA4500 Administered Two Times a Week for Up to Three Treatment Cycles (2 x 3) in Subjects With Peyronie's Disease
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
Read the detailed description
A Phase 2b randomized, double-blind, placebo-controlled study of AA4500 in the treatment of subjects with Peyronie's disease.
During the screening period, subjects had a physical examination including body weight and height, vital sign measurements, a 12-lead electrocardiogram (ECG), and clinical laboratory testing. Medical history, prior and concomitant medications, and demographic data were recorded.
- Conditions
- Peyronie's Disease
- Being tested
- AA4500, Placebo
- Keywords
- Peyronie's disease, penile plaque, penile curvature
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AA4500Biological
Also called Clostridial collagenase for injection (AA4500)
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.
PlaceboBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| AA4500 | Experimental | Clostridial collagenase for injection Receives: Biological: AA4500 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Penile Curvature
Negative change reflects improvement in penile curvature
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 36 or LOCF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peyronie's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Veronica Urdaneta, MD, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755222
- Sponsor's protocol ID
- AUX-CC-801
- Status last verified
- Sep 2017
- First submitted
- 16 Sep 2008
- Last updated
- 5 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effectiveness of AA4500 Administered Two Times a Week for Up to Three Treatment Cycles (2 x 3) in Subjects With Peyronie's Disease
- ClinicalTrials.gov ID
- NCT00755222
- Acronym / sponsor ID
- AUX-CC-801
- Conditions
- Peyronie's Disease
- Keywords
- Peyronie's disease, penile plaque, penile curvature
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Sep 2008 (estimated)
- Results
- Posted 26 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
A Phase 2b randomized, double-blind, placebo-controlled study of AA4500 in the treatment of subjects with Peyronie's disease.
During the screening period, subjects had a physical examination including body weight and height, vital sign measurements, a 12-lead electrocardiogram (ECG), and clinical laboratory testing. Medical history, prior and concomitant medications, and demographic data were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AA4500 | Experimental | Biological: AA4500Clostridial collagenase for injection |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (30 listed)
- 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:
- Previously undergone surgery for Peyronie's disease
- Penile curvature of less than 30° or greater than 90°
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AA4500Also: Clostridial collagenase for injection (AA4500)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. | Biological | AA4500 |
| Placebo2 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. | Biological | Placebo |
Primary outcome
Change From Baseline in Penile Curvature
Time frame: Baseline and Week 36 or last observation carried forward (LOCF)
Negative change reflects improvement in penile curvature
Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie's Disease Symptom Bother
Time frame: Baseline to Week 36 or LOCF
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.
Change From Baseline in PDQ Intercourse Contraint
Time frame: Baseline to Week 36 or LOCF
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.
Change From Baseline in PDQ Intercourse Discomfort
Time frame: Baseline to Week 36 or LOCF
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.
Change From Baseline in PDQ Penile Pain
Time frame: Baseline to Week 36 or LOCF
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Urdaneta, MD study director
Endo USA Inc., a Keenova Therapeutics Company
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AA4500 in people with Peyronie's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Penile Curvature (time frame: Baseline and Week 36 or last observation carried forward (LOCF)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.