Comparison of Letrozole Versus Danazole for Pain Management of Female Presenting With Endometriosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in pelvic pain severity (0-10 Numeric Rating Scale)
研究概览
简要总结
Background:
Endometriosis is a chronic gynecological condition defined by the ectopic presence of endometrial glands and stroma outside the uterine cavity, most commonly diagnosed via laparoscopy. While its exact etiology remains uncertain, a positive family history is considered a significant risk factor. Danazol has historically demonstrated efficacy in alleviating endometriosis-related pain, while letrozole, primarily used in neoadjuvant settings, has recently emerged as a promising alternative. This study aimed to compare the mean reduction in pain scores between letrozole and danazol in women with laparoscopically confirmed endometriosis.
Objective:
To compare the efficacy of letrozole versus danazol in reducing pain scores among women diagnosed with endometriosis.
Material & Methods:
Study Design: Randomized control trial Setting: Department of Obstetrics & Gynaecology, Sharif Medical and Dental Hospital
详细描述
Introduction:
Endometriosis is defined by the ectopic presence of functional endometrial glands and stroma outside the uterine cavity, most commonly diagnosed via direct laparoscopic visualization (1). Clinical manifestations include dysmenorrhea, dyspareunia, chronic pelvic pain, and infertility-each of which may significantly impair a woman's quality of life (2). It is a chronic, estrogen-dependent inflammatory condition predominantly affecting women of reproductive age, though adolescents may also be affected (3). Its true prevalence remains uncertain due to underdiagnosis and a diagnostic delay averaging nearly a decade, often attributed to normalization of symptoms and missed recognition by primary care providers. Beyond physical symptoms, endometriosis exerts a profound psychosocial and economic burden on affected individuals, their families, and healthcare systems globally (4).
Pathophysiology and Clinical Impact of Ectopic Endometrial Tissue in Endometriosis Ectopic endometrial tissue typically localizes in the dependent regions of the pelvis, such as the posterior and anterior cul-de-sac, uterosacral ligaments, ovaries, and fallopian tubes; however, extra-pelvic involvement is also possible (5). These implants respond to cyclic hormonal stimulation much like eutopic endometrium, undergoing phases of proliferation, secretion, and subsequent shedding. The metabolic by-products especially cytokines and prostaglandins foster a chronic inflammatory milieu characterized by neovascularization, fibrosis, and pain sensitization. Immunologic dysregulation is also implicated, including aberrant T- and B-cell responses, complement system activation, and elevated interleukin-6 (IL-6) levels in affected individuals. These immunoinflammatory mechanisms lead to adhesion formation, anatomic distortion, and chronic pelvic pain which are the hallmark features of the disease (5).
Classification of Endometriosis:
Endometriosis can be classified into three main types based on lesion location. Superficial peritoneal endometriosis is the most common form, characterized by lesions affecting the peritoneum, the thin membrane lining the pelvic cavity. Endometriomas, or ovarian lesions, are dark, fluid-filled cysts ("chocolate cysts") that develop within the ovaries, often resistant to treatment and capable of damaging healthy ovarian tissue. Deeply infiltrating endometriosis extends beneath the peritoneal surface and may involve adjacent pelvic organs such as the bowel or bladder, occurring in approximately 1% to 5% of affected women (6). (Figure 1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study due to differences in drug formulations. Participants and investigators will know the assigned intervention; outcomes will be measured using validated patient-reported scales to reduce bias."
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-45 years
- •Surgically or clinically diagnosed endometriosis
- •Moderate to severe pelvic pain (NRS ≥ 4 for at least 3 months)
- •Willing to use effective contraception during the study
- •Able to provide informed consent
排除标准
- •Pregnant or breastfeeding
- •Severe hepatic disease, thromboembolic disorder, or contraindication to study drugs
- •Use of hormonal therapy within the last 8 weeks
- •Known hypersensitivity to Letrozole or Danazol
- •Participation in another clinical trial within the last 3 months
研究组 & 干预措施
Arm 1: Letrozole
Participants in this arm will receive Letrozole 2.5 mg orally once daily for 12 weeks for management of endometriosis-related pelvic pain.
干预措施: Letrozole (Drug)
Arm 2: Danazol
Participants in this arm will receive Danazol 200 mg orally twice daily for 12 weeks for management of endometriosis-related pelvic pain.
干预措施: danazol (Drug)
结局指标
主要结局
Change in pelvic pain severity (0-10 Numeric Rating Scale)
时间窗: 12 weeks
Mean change in pelvic pain scores measured on a 0-10 numeric rating scale; lower scores indicate improvement.
次要结局
- Change in dysmenorrhea severity(12 weeks)
研究者
Sidra Salman
FCPS TRANIEE
Sharif Medical And Dental College, Lahore
