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临床试验/NCT05873595
NCT05873595终止不适用

Clinical Understanding Through Real-world Data to Validate Effectiveness of Treatments in Peyronie's Disease

Endo Pharmaceuticals7 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2023年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
29
试验地点
7
主要终点
Number of Participants Receiving Each Treatment Type for PD

研究概览

简要总结

This 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.

详细描述

Each participant of the study will have their data collected from the date of confirmed diagnosis of PD to the date of enrollment in the registry, post consent. Data will be collected from the participant's clinical records as well as from the participant directly. Data will be collected through Pulse Infoframe's technology platform.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Any adult with a confirmed clinical diagnosis of PD.
  • Age 18 years (or age of majority in their jurisdiction) or older at time of enrollment.
  • Willing to participate in the registry (including completion of ePROs) and complete the informed consent form.
  • Having received PD treatment within 2 weeks before enrollment, at enrollment or any time after the date of enrollment. After a confirmed diagnosis of PD, not having received PD treatment.
  • Able to participate in English based registry.
  • Key Exclusion criteria:
  • Not having a clinical diagnosis of PD.
  • Age less than 18 years.
  • Do not provide informed consent.

排除标准

  • 未提供

结局指标

主要结局

Number of Participants Receiving Each Treatment Type for PD

时间窗: Up to 12 months

次要结局

  • Participant Satisfaction Questionnaire(Up to 12 months)
  • Number of Participants Receiving Post-Procedural Care by the Treating Physician(Up to 12 months)
  • Change from Baseline in Peyronie's Disease Questionnaire (PDQ) Score(Up to 12 months)
  • Change from Baseline in International Index of Erectile Function (IIEF) Score(Up to 12 months)
  • Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score(Up to 12 months)
  • Change from Baseline in Beck Anxiety Inventory (BAI) Scale Score(Up to 12 months)

研究者

发起方
Endo Pharmaceuticals
申办方类型
Industry
责任方
Sponsor

研究点 (7)

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