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ALPROSTADIL

Clinical trials investigating ALPROSTADIL are being used in a study of Peyronie’s disease. The trial looks at safety, tolerability, and how well penile curvature can be measured after erection is induced with ALPROSTADIL. The target population is patients with Peyronie’s disease.

Table of contents

Trial overview

This authorised interventional study is titled a Phase I/II study to evaluate the efficacy and safety of bacterial collagenase in patients with Peyronie’s disease.[1] The trial includes ALPROSTADIL as part of the study procedures, and the target condition is Peyronie’s disease.[1]

The study plans to enroll 100 participants.[1] The trial status is Authorised.[1]

Study design and phase

This is an interventional trial, which means researchers are giving a treatment and then checking the results.[1] The source data list the study as Phase 1, and the brief summary explains that it has both Phase I and Phase II parts.[1]

In the Phase I part, the main goal is to study the safety and tolerability of each tested escalating dose of V. alginolyticus collagenase, given as a single injection into the plaque that causes the penis deformity.[1] The researchers want to identify the Maximum Tolerated Dose, which means the highest dose patients can handle without too many serious problems in the study.[1]

In the Phase II part, the main goal is to assess how much the maximal penile curvature improves from baseline after treatment.[1]

Who can participate

The study is designed for patients with Peyronie’s disease.[1] The trial data do not provide more detailed entry rules, such as age limits or other medical conditions, so those details cannot be confirmed from the source.[1]

The intervention list includes VIBRIO ALGINOLYTICUS COLLAGENASE for intralesional use and ALPROSTADIL for intracavernous use.[1] “Intralesional” means injected into the lesion or plaque, and “intracavernous” means placed into the erectile tissue of the penis.[1]

What is measured in the trial

The Phase I primary endpoint is the overall safety and tolerability profile of each tested escalating dose, used to find the Maximum Tolerated Dose.[1] This helps the researchers understand whether the treatment can be given safely in the study setting.[1]

The Phase II primary endpoint is the percentage of reduction in maximal penile curvature deformity from baseline at specific time points after treatment.[1] One time point is 29±2 days after the 3rd injection for Dose regimen A, and another is 42±2 days after the 8th injection for Dose regimen B.[1]

Penile curvature is measured with a goniometer protractor device after erection is induced with ALPROSTADIL.[1] A goniometer is a tool used to measure angles, so it helps the team measure how bent the penis is.[1]

How ALPROSTADIL is used in the study

ALPROSTADIL is not the main treatment being tested in this trial, based on the source data.[1] Instead, it is used during the measurement process to induce an erection so the researchers can measure penile curvature more accurately.[1]

This means ALPROSTADIL supports the study’s assessment of the main treatment effect, which is the change in curvature after the collagenase injections.[1]

Patient-friendly terms

Plaque means a firm area or lump in the penis that can cause bending.[1]

Escalating dose means the amount of treatment is slowly increased step by step during the study.[1]

Baseline means the first measurement taken before treatment starts.[1]

Endpoint means the main result the researchers want to measure in the trial.[1]

Efficacy means how well the treatment works for the study goal.[1]

Tolerability means how well patients can handle the treatment.[1]

Trial ID Phase Condition studied Status Enrollment
2023-509621-45-00 Phase 1 Peyronie’s Disease Authorised 100

FAQ

  • What is being studied in the ALPROSTADIL trial? The study is mainly about bacterial collagenase for Peyronie’s disease. ALPROSTADIL is used in the trial to help induce an erection so penile curvature can be measured.
  • Who can take part in this trial? The target population is patients with Peyronie’s disease. The trial data do not give more detailed participation rules.
  • What phase is this ALPROSTADIL trial? This is a Phase 1 study. The trial description also says it has Phase I and Phase II parts.
  • What outcomes are being measured? The Phase I part measures safety and tolerability to find the maximum tolerated dose. The Phase II part measures the percentage reduction in maximal penile curvature after treatment.
  • How is penile curvature measured in the study? Penile curvature is measured with a goniometer protractor device. The measurement is done after erection is induced with ALPROSTADIL.

Ongoing Clinical Trials on ALPROSTADIL

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

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Peyronie’s disease: A condition that causes a bend or deformity of the penis.
  • Interventional study: A clinical trial where researchers give a treatment or procedure and then measure the results.
  • Phase 1: An early trial phase that mainly checks safety and tolerability.
  • Phase II part: A later part of the study that looks more closely at whether the treatment works.
  • Safety: How well a treatment is tolerated and whether it causes unwanted problems.
  • Tolerability: How comfortable and manageable a treatment is for patients.
  • Maximum Tolerated Dose: The highest dose that patients can take without too many serious side effects in the study.
  • Penile curvature: The angle or bend of the penis, which is measured in this trial.
  • Baseline: The first measurement taken before treatment starts.
  • Goniometer protractor device: A tool used to measure angles, here used to measure penile curvature.

References

  1. https://clinicaltrials.gov/study/2023-509621-45-00