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Peyronie's DiseasePhase 3NCT02267460

An Open-label Study to Assess the Safety and Effectiveness of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Treating Men With Peyronie's Disease

A Phase 3 study testing AA4500, ErecAid® Esteem® Manual Vacuum Therapy System and Investigator Modeling in people with Peyronie's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Enrollment will include approximately 30 AA4500 naïve subjects. Subjects will be divided by degree of penile curvature and then randomized in a 1:1 ratio to one of the following treatment groups: AA4500 with investigator modeling AA4500 without investigator modeling Each subject will receive 2 injections of AA4500… 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, ErecAid® Esteem® Manual Vacuum Therapy System and Investigator Modeling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2014to Mar 2016
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Be a male ≥ 18 years of age
  • Have symptom(s) of Peyronie's disease and have evidence of stable disease as determined by the investigator
  • 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
  • Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile
  • Voluntarily sign and date an informed consent agreement approved by the Independent Ethics Committee (IEC).
  • Be able to read, complete and understand the various rating instruments in English.

Who cannot join

  • Has a penile curvature of less than 30° or greater than 90° at the screening visit
  • 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
Show all 35Show fewer
  • 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)
  • Has a history of spontaneous priapism (ie, erection that lasts more than four hours)
  • Has previously undergone surgery for Peyronie's disease
  • 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
  • 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
  • Has an isolated hourglass deformity of the penis
  • 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
  • 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-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
  • 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
  • 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
  • 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
  • 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
  • Has significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors
  • Has a penile Duplex Doppler ultrasound evaluation at screening that shows compromised penile hemodynamics that in the opinion of the investigator is clinically significant
  • Has uncontrolled hypertension, as determined by the investigator
  • 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 enrollment in the study
  • Has sickle cell trait or disease, multiple myeloma, Hodgkin's lymphoma, and/or a blood dyscrasia that carries the risk for clotting or priapism
  • Has an impairment of the hand(s) that would prevent safe use of the vacuum pump, as determined by the investigator
  • Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits
  • Has received an investigational drug or treatment within 30 days before the first dose of study drug
  • Has a known allergy to collagenase or any other excipient of AA4500
  • Has a known allergy to any concomitant medication required as per the protocol
  • Has a coagulation disorder
  • Is taking a medication for chronic anticoagulation (except for ≤ 150 mg aspirin daily)
  • Has received any collagenase treatments within 30 days of the first dose of study drug
  • Has, at any time, received AA4500 for the treatment of Peyronie's disease

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Hospital of St John and St Elizabeth

    London, NW8 9NH

Other trials in United Kingdom

About this study

Official title: A Phase 3b, Open-label Pilot Study to Evaluate the Safety and Effectiveness of up to Four Treatment Cycles of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Men With Peyronie's Disease

Enrollment will include approximately 30 AA4500 naïve subjects. Subjects will be divided by degree of penile curvature and then randomized in a 1:1 ratio to one of the following treatment groups:

  • AA4500 with investigator modeling
  • AA4500 without investigator modeling

Each subject will receive 2 injections of AA4500, separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles.

Approximately 14 days after the second injection of AA4500, each subject will visit the study site and the investigator will assess the subject and instruct the subject on appropriate use of the ErecAid® Esteem® Manual Vacuum Therapy System.

Being tested
AA4500, ErecAid® Esteem® Manual Vacuum Therapy System, Investigator Modeling
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 Xiaflex, Xiapex, collagenase clostridium histolyticum

  • ErecAid® Esteem® Manual Vacuum Therapy SystemDevice

  • Investigator ModelingProcedure or surgery

Study groups in NCT02267460
Study groupRoleWhat they receive
AA4500 with investigator modeling and vacuum therapyActive comparatorAA4500 with investigator modeling and home use of the ErecAid® Esteem® Manual Vacuum Therapy System.
Receives: Biological: AA4500; Device: ErecAid® Esteem® Manual Vacuum Therapy System; Procedure: Investigator Modeling
AA4500 without investigator modeling/with vacuum therapyActive comparatorAA4500 without investigator modeling but with home use of the ErecAid® Esteem® Manual Vacuum Therapy System.
Receives: Biological: AA4500; Device: ErecAid® Esteem® Manual Vacuum Therapy System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent in improvement from baseline in penile curvature

    measurement of erect penis at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)

    Measured: 36 Weeks

Secondary outcomes (7)

  1. Change in Peyronies disease bother

    Questionnaire at Day 168 (follow up 1) and day 252 (follow up 2)

    Measured: 36 Weeks

  2. Change in Peyronies disease physical symptoms

    measurement of erect penis at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)

    Measured: Week 36

  3. Change in Peyronies disease psychological symptoms

    Questionnaire at Day 168 (follow up 1) and day 252 (follow up 2)

    Measured: 36 Weeks

  4. Change in penile plaque consistency

    Flaccid penile exam at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)

    Measured: 36 Weeks

  5. Change in penile length

    Flaccid penile exam at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)

    Measured: 36 Weeks

  6. Change in Peyronies disease penile pain

    examination for pain done on day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)

    Measured: 36 Weeks

  7. A responder analysis based on subject global assessment

    Questionnaire at Day 168 (follow up 1) and day 252 (follow up 2)

    Measured: 36 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionOct 2015
  4. Study completionMar 2016

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02267460
Sponsor's protocol ID
AUX-CC-807
Status last verified
Nov 2017
First submitted
7 Oct 2014
Last updated
8 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • Ralph DJ, Abdel Raheem A, Liu G. Treatment of Peyronie's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy: A Randomized, Open-Label Pilot Study. J Sex Med. 2017 Nov;14(11):1430-1437. doi: 10.1016/j.jsxm.2017.08.015. Epub 2017 Sep 30.

    PubMed 28974406

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AA4500, ErecAid® Esteem® Manual Vacuum Therapy System and Investigator Modeling in people with Peyronie's Disease, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in United Kingdom.

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 6 inclusion and 35 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 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percent in improvement from baseline in penile curvature (time frame: 36 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02267460, which also lists 1 linked publication.

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 8 Nov 2017.

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