Table of contents
- Trial overview
- Study design and phase
- Who can participate
- What is measured in the trial
- How ALPROSTADIL is used in the study
- Patient-friendly terms
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]
