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临床试验/EUCTR2006-004752-21-SE
EUCTR2006-004752-21-SE进行中(未招募)不适用

Pertubation with Lignocaine in Endometriosis Associated Symptoms Effect study (PLEASE) - PLEASE

Karolinska Institute, Danderyds hospital0 个研究点开始时间: 2006年9月19日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Women 20-40 years,
  • Endometriosis verified by laparoscopy,
  • Dysmenorrhea or pelvic pain, , defined as having a pain-score of >5 at the visual analogue scale(VAS),
  • Normal Fallopian tubes,
  • Regular menstruation bleeding (If not on hormonal treatment she should have been without combined contraceptive pills or gestagens for 1 month or without GnRH-agonists for at least 6 months, Treatment with oral contraceptives should have been ongoing for at least 1 month and shall continue during the trial),
  • No wish for pregnancy at present,
  • Normal Pap-smear,
  • Negative Chlamydia-test
  • Negative pregnancy-test.
  • Informed consent given and signed
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Exclusion criterias:
  • Continous treatment with NSAID, corticosteroids or other medicine that may increase risk for infection,
  • Clinical signs of pelvic inflammatory disease,
  • Known hyperreactivity to local anesthesia,
  • Fibriods>2cm,
  • Ongoing treatment with GnRH-analog,
  • Ongoing continous treatment with gestagens,
  • Pregnancy or wish for pregnancy the forthcoming year,
  • Pelvic adhesions,
  • Verified occluded or reduced patency in the 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.

研究者

发起方
Karolinska Institute, Danderyds hospital

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