Intralesional Hyaluronic Acid and Verapamil Injection in Peyronie's Disease
Peyronie's DiseaseHyaluronic Acid1 moreThe aim of the present study is to investigate whether intralesional injections of Hyaluronic acid in the acute phase could reduce the progression of Peyronie's disease thanks to its interference with inflammatory and pro-fibrotic processes. Therefore, a prospective, longitudinal, double-blinded, randomized clinical study, has been designed to evaluate and compare the efficacy and safety of intralesional HA as compared with the use of verapamil injection in patients affected by Peyronie's disease.
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's...
Peyronie DiseaseSexual Dysfunctions3 moreThe purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's...
Peyronie DiseaseErectile DysfunctionThe purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.
French Translation and Validation of the PEYronie's Disease QUESTionnaire
Peyronie DiseaseThis study is a prospective cohort dedicated to peyronie's disease. The aim is to validate the french translation of the peyronie's disease questionnaire. The primary endpoint is the response rate to the questionnaire.
Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease
Peyronie's DiseaseThis is an observational study, meaning participants will not receive any investigational treatment as part of this study. Researchers will collect real-world data (RWD) to gain a more in-depth knowledge of the treatment of Peyronie's Disease (PD) to evaluate the management of PD.
Xiaflex® Plus Testosterone Treatment Pilot Study Protocol
Peyronie's Disease (PD)In this open-label, six-month, pilot study of men with Peyronie's disease there will be one subject group consisting of 20 subjects. All subjects will receive Xiaflex® plus testosterone (T) treatment (Aveed®). Males included in the study must be 18-70 years old; have a history of PD for more than six months; and have at two serum total testosterone level less than 350 ng/dL within 30 days prior to enrollment. The primary objective of this pilot study is to determine whether testosterone therapy offers increased efficacy of Xiaflex® (collagenase clostridium histolyticum) in subjects undergoing treatment for Peyronie's disease. Endpoints will include reduction in degree of curvature and response to the PDQ questionnaire. Secondary objectives will be to assess men for change in plaque size, quality of life parameters, and sexual function. Data collected from this pilot study will be analyzed and compared to historical data regarding treatment for PD using Xiaflex® only. This pilot study will establish preliminary evidence needed to continue more in-depth research regarding Xiaflex® with T therapy and serve as a means to evaluate feasibility of a full-scale study.
A Phase 3, Open-label Study of the Safety and Effectiveness of AA4500 Administered Twice Per Treatment...
Peyronie's DiseaseThis study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. Enrollment will include all subjects who meet the eligibility criteria and who received placebo and completed one of the Auxilium-sponsored studies AUX-CC-803 or AUX-CC-804.
A Study of AA4500 in Men With Peyronie's Disease
Peyronie's DiseaseThis study is a Phase 3, open-label study of the safety and efficacy of AA4500 0.58 mg in subjects with Peyronie's disease. Subjects will be screened for study eligibility within 21 days before the initial injection of study drug in the first treatment cycle. After up to four treatment cycles, each subject will be followed for additional safety and efficacy assessments on Days 168 (± 7 days) and 252 (± 7 days) (nominal weeks 24 and 36). After the final injection of each treatment cycle, the investigator will model the plaque in an attempt to stretch or elongate the plaque. If the subject's penile curvature is reduced to <15° after the first, second, or third cycle of injections or if the investigator determines further treatment is not clinically indicated (eg, adverse events; allergic reaction), subsequent treatment cycles will not be administered. Approximately 300 subjects will be enrolled.
The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease
Peyronie's DiseaseThis study evaluated the safety and effectiveness of AA4500 in improving the impact of Peyronie's disease on quality of life and improving penile curvature in men with Peyronie's disease
Testosterone Pellets Plus Vitamin D and E Versus Vitamin D and E Alone for the Treatment of Peyronie's...
Peyronie's DiseaseTwo recent studies have identified low levels of serum testosterone in association with Peyronie's Disease (PD), with a significant correlation noted between severity of testosterone deficiency and severity of curvature. The study hypothesis is to determine whether treatment with testosterone may help men with PD and penile curvature.