Impact of the Antihistamine Desloratadine on the Quality of Life and Dysmenorrhea in Patients With Endometriosis
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
- 否
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
干预措施: Placebo (Drug)
Drug-Group
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
René Wenzl
Ao. Univ.-Prof. Dr. med. univ. René Wenzl, MSc
Medical University of Vienna
