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Study on the Safety and Effectiveness of Vibrio Alginolyticus Collagenase and Alprostadil for Patients with Peyronie’s Disease

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What is this study about?

This clinical trial is focused on studying a condition known as Peyronie’s Disease, which affects the penis and can cause it to curve abnormally. The study will use a treatment called Vibrio alginolyticus collagenase, which is a type of enzyme that breaks down proteins. This enzyme will be injected directly into the plaque, which is the area causing the curvature. The study will also involve the use of Alprostadil, a medication that helps induce an erection, to measure changes in the curvature of the penis.

The purpose of the study is to evaluate the safety and effectiveness of the enzyme treatment. The study will be conducted in two phases. In the first phase, different doses of the enzyme will be tested to find the safest and most effective dose. In the second phase, this dose will be used to see how well it improves the curvature of the penis. Participants will receive injections of the enzyme and will be monitored for any changes in their condition, as well as any side effects they might experience.

Throughout the study, participants will have regular check-ups to assess the impact of the treatment on their condition. The study aims to provide a better understanding of how this enzyme can help treat Peyronie’s Disease and improve the quality of life for those affected by it. The study will continue until the estimated end date in 2027.

1 Phase I: Initial Evaluation

The initial phase involves a single injection of Vibrio alginolyticus collagenase directly into the plaque causing the penile deformity. This is done to determine the maximum dose that can be tolerated safely.

The injection is administered through intralesional use, meaning it is injected directly into the affected area.

2 Phase I: Monitoring and Assessment

After the injection, the safety and tolerability of the dose are monitored. This includes checking for any side effects and measuring the levels of the drug in the blood at various intervals.

The effects on symptoms and overall impact on life are evaluated approximately 29 days after the injection.

3 Phase II: Efficacy Evaluation

In this phase, the effectiveness of the maximum tolerated dose identified in Phase I is assessed. The goal is to see how much the penile curvature improves from the baseline.

The treatment involves multiple injections, with the number depending on the specific regimen being followed.

4 Phase II: Treatment Regimen A

For Dose regimen A, three injections are administered. The improvement in penile curvature is measured 29 days after the third injection.

The injections are given at specific intervals, and the curvature is measured using a device that assesses the angle of the curvature.

5 Phase II: Treatment Regimen B

For Dose regimen B, a total of eight injections are administered over four treatment cycles. The improvement is assessed 42 days after the eighth injection.

The same measurement techniques are used to evaluate changes in curvature and other related parameters.

6 Phase II: Follow-Up and Final Assessment

After the final injection, follow-up assessments are conducted to evaluate the long-term effects of the treatment.

These assessments include measuring changes in penile length, curvature, and overall satisfaction with the treatment.

Who Can Join the Study?

  • Informed Consent: You must sign a written form agreeing to participate in the study before you can join.
  • Sex and Age: You must be a man who is 18 years old or older.
  • Peyronie’s Disease: You need to have been diagnosed with Peyronie’s Disease for at least 12 months. This means you have a stable curve in your penis between 30° and 90° without pain during an erection, and it hasn’t changed for at least a year. You also need a score of 17 or higher on a specific questionnaire about erectile function.
  • Full Comprehension: You must understand the study’s purpose, risks, and side effects. You should be able to work with the study team and follow all study instructions, including certain exercises.
  • Relationship: You need to have been in a stable relationship with a partner for at least 3 months before the study and be willing to have sexual intercourse with that partner.
  • Contraception and Fertility:
    • You must agree to not have sex for 15 days after injections in the first part of the study.
    • In the second part of the study, you must agree to not have sex for 15 days after each injection or treatment cycle.
    • If your female partner can have children, you must agree to use a male condom.
    • If your partner is unable to have children, you must confirm this.

Who Cannot Join the Study?

  • Only male participants can join the study. Female participants are not eligible.
  • Participants must be within a certain age range. If you are outside this range, you cannot participate.
  • Participants must have Peyronie’s Disease, which is a condition that causes a bend in the penis due to a plaque or scar tissue.
  • Participants should not belong to a vulnerable population, which means groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
03.02.2025

Trial locations

Investigated drugs:

Vibrio alginolyticus collagenase is being studied for its potential to treat Peyronie’s Disease. This condition causes a deformity of the penis due to plaque buildup. The medication is injected directly into the plaque to help break it down, which may reduce the curvature of the penis. The study aims to determine the safest and most effective dose of this treatment.

Investigated diseases:

Peyronie’s Disease – This condition involves the development of fibrous scar tissue inside the penis, which can cause curved, painful erections. It often begins with inflammation or injury, leading to the formation of a hard plaque under the skin of the penis. Over time, this plaque can cause the penis to bend or become misshapen during an erection. The curvature can vary in severity and may worsen over time. Some men with Peyronie’s Disease may also experience erectile dysfunction or shortening of the penis. The exact cause of the disease is not fully understood, but it may be related to trauma or genetic factors.

Trial ID:
2023-509621-45-00
Protocol code:
RRE8_23_01
Trial Phase:
Human Pharmacology (Phase I) – Other

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