Pertubation With Lignocaine in Endometriosis Associated Symptoms Effect Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Isifer AB
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale.
研究概览
简要总结
Endometriosis is a disease of unknown aetiology that can cause severe dysmenorrhea. An altered immune system with elevated levels of cytokines in the peritoneal fluid as well as increased density of nerve fibres, might explain the pathophysiology of dysmenorrhea in endometriosis patients. Lignocaine has anti-inflammatory properties and exerts effect on nerve endings and intra peritoneal macrophages. Pertubation with lignocaine might represent an alternative treatment for endometriosis related dysmenorrhea and avoids the side-effects related to hormonal treatments. A double blind randomized clinical trial, was carried out to evaluate pertubation with lignocaine as a therapy for dysmenorrhea.
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)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 20 years
- •endometriosis verified by laparoscopy
- •dysmenorrhea or pelvic pain defined as a pain-score of >50 mm (VAS)
- •normal Fallopian tubes
- •regular menstrual cycles 21-35 days
- •treatment with oral contraceptives (OC) ongoing > 1 month and continued during the trial
- •previous hormonal treatment discontinued > 1 month (OC, gestagens) and > 6 months (GnRH)
- •no wish for pregnancy during the study
- •normal Pap-smear
- •negative Chlamydia-test
- •negative pregnancy-test
- •informed consent given and signed
排除标准
- •Continuous treatment with medication that may increase risk for infection - clinical signs of pelvic inflammatory disease
- •hyperreactivity to local anesthesia
- •fibroids > 2 cm
- •ongoing treatment with GnRH-analog
- •ongoing continuous treatment with high dose gestagens
- •pregnancy
- •peritubal adhesions
- •occluded Fallopian tubes
- •inability to understand information or comply with the study procedures
- •participation in a clinical study within one year before the present study
- •any disease or laboratory finding considered of importance by the investigator not to include the patient
研究组 & 干预措施
Pertubation with Endole® (lignocaine)
Three treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
干预措施: Lignocaine (Drug)
Placebo
Pertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
干预措施: Ringers Solution (Drug)
结局指标
主要结局
Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale.
时间窗: After three pertubations
The pain-questionnaire will be filled out: first time during the first period after inclusion in the study (1st menstruation prior to study treatments=baseline for evaluation) and thereafter during 2nd, 3rd, 4 th, 7th, 10th and 13th menstrual periods.
次要结局
- Quality of life-questionnaire (validated), EHP-30(At the 7th menstruation i.e. after approximately 6 months.)