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临床试验/NCT07821320
NCT07821320尚未招募2 期

Impact of the Antihistamine Desloratadine on the Quality of Life and Dysmenorrhea in Patients With Endometriosis

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2027年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Change in the EHP-30 Score

研究概览

简要总结

Endometriosis is a chronic inflammatory disease affecting approximately 10% of women in their reproductive years. It is characterized by the presence of endometrial-like tissue outside the uterine cavity. Current treatment options include hormonal therapies or surgical excision of the endometriotic lesions. Although these interventions often lead to a significant symptom relief, some patients still experience persistent pain or treatment-related adverse effects. Consequently, the management of dysmenorrhea and improvement of quality of life in patients with endometriosis remain a clinical challenge.

Desloratadine is widely used for the treatment of allergic rhinitis or chronic urticaria. Recent studies suggest that desloratadine may also possess analgesic and anti-inflammatory properties. So far, however, no clinical studies have investigated its potential therapeutic effects in patients with endometriosis.

Therefore, the present study aims to provide the first clinical assessment of the efficacy, safety and tolerability of desloratadine in patients with endometriosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Masking Description

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged 18-50
  • By imaging (sonography or MRI) or surgery last 10 years confirmed endometriosis
  • EHP-30 Score > 40

排除标准

  • Subject is unable or unwilling to participate
  • History of malignant diseases
  • Current immunosuppressant treatment
  • History of allergies and/or usage of antihistaminic treatments
  • Postmenopausal women
  • Current hormonal treatment
  • Surgical treatment <1year

研究组 & 干预措施

Control-Group

Placebo Comparator

干预措施: Placebo (Drug)

Drug-Group

Active Comparator

干预措施: Desloratadine (Drug)

结局指标

主要结局

Change in the EHP-30 Score

时间窗: from enrollment to the end of treatment at 150 days"

次要结局

  • Change in Dysmenorrhea using the visual analogue scale (0-10)(From enrollment to the end of treatment at 150 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

René Wenzl

Ao. Univ.-Prof. Dr. med. univ. René Wenzl, MSc

Medical University of Vienna

研究点 (1)

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