In short
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.
Key points
- One authorised clinical trial is studying ALPROSTADIL in patients with Peyronie’s disease. The main focus is not ALPROSTADIL alone, but how it is used in the study to help measure penile curvature after erection is induced. The trial has Phase I and Phase II parts and includes 100 participants. Phase I looks at safety, tolerability, and the maximum tolerated dose of bacterial collagenase. Phase II looks at how much penile curvature improves after treatment. The study uses a goniometer protractor device to measure the angle of curvature.
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. The trial includes ALPROSTADIL as part of the study procedures, and the target condition is Peyronie’s disease.
The study plans to enroll 100 participants. The trial status is Authorised.
Study design and phase
This is an interventional trial, which means researchers are giving a treatment and then checking the results. The source data list the study as Phase 1, and the brief summary explains that it has both Phase I and Phase II parts.
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. 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.
In the Phase II part, the main goal is to assess how much the maximal penile curvature improves from baseline after treatment.
Who can participate
The study is designed for patients with Peyronie’s disease. 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.
The intervention list includes VIBRIO ALGINOLYTICUS COLLAGENASE for intralesional use and ALPROSTADIL for intracavernous use. “Intralesional” means injected into the lesion or plaque, and “intracavernous” means placed into the erectile tissue of the penis.
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. This helps the researchers understand whether the treatment can be given safely in the study setting.
The Phase II primary endpoint is the percentage of reduction in maximal penile curvature deformity from baseline at specific time points after treatment. 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.
Penile curvature is measured with a goniometer protractor device after erection is induced with ALPROSTADIL. A goniometer is a tool used to measure angles, so it helps the team measure how bent the penis is.
How ALPROSTADIL is used in the study
ALPROSTADIL is not the main treatment being tested in this trial, based on the source data. Instead, it is used during the measurement process to induce an erection so the researchers can measure penile curvature more accurately.
This means ALPROSTADIL supports the study’s assessment of the main treatment effect, which is the change in curvature after the collagenase injections.
Patient-friendly terms
Plaque means a firm area or lump in the penis that can cause bending.
Escalating dose means the amount of treatment is slowly increased step by step during the study.
Baseline means the first measurement taken before treatment starts.
Endpoint means the main result the researchers want to measure in the trial.
Efficacy means how well the treatment works for the study goal.
Tolerability means how well patients can handle the treatment.