Treatment of Endometriosis Pain With Rosiglitazone: A Prospective Phase 2 Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- 28-day visual analog scale diary (one for each day for 4 weeks) at baseline and at conclusion of 6 months
研究概览
简要总结
The purpose of this study is to perform a pilot study on the efficacy of rosiglitazone in reducing pelvic pain in early stage endometriosis patients.
详细描述
There is no current pain control in women with minimal-mild endometriosis that concomitantly allows them the chance to conceive. Women between the ages of 18 and 45 years with minimal to mild endometriosis and pelvic pain of greater than three months duration, will be enrolled into a 6-month prospective phase 2 clinical trial.
Comparison: Following enrollment, one week after the last menstrual period, eligible participants will be randomized to a 6-month treatment of rosiglitazone 4 mg/day. Efficacy comparisons will be made utilizing visual analog scale diaries, Short-Form McGill Pain Questionnaires and physical component summary scores of the SF-36. Secondary measures will include cytokine quantification, proteomics, gene array analyses and serious adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Healthy women ages 18 - 45 years.
- •Regular menstrual cycles (24-35 days).
- •Pelvic pain ≥ 3 months with cyclical component.
- •Negative pregnancy test and must use nonhormonal contraception.
- •Non-lactating.
- •No history of liver disease.
- •Consent to participate in the study.
- •Endometriosis diagnosed from surgical specimen by routine hematoxylin and eosin staining and histological evaluation within the past 4 years.
排除标准
- •Major psychiatric conditions or the abuse of alcohol or drugs which would make it difficult for the subject to complete study procedures.
- •Active or prior infection with hepatitis, human immunodeficiency virus (HIV) infection, or history of high-risk activities (e.g., IV drug abuse) which would increase risk to laboratory personnel. Of note, no testing for hepatitis or HIV will be performed as part of this study and all tissues will be handled and discarded as if they were potentially infected.
- •Patients with liver dysfunction (elevated liver enzymes > 2 times the upper limit of normal).
- •Presence of pre-existing malignancy, including carcinoma of the breast or uterus.
- •Women with other causes of chronic pelvic pain including infectious, gastrointestinal, musculoskeletal, neurologic or psychiatric.
- •Elevated WBC.
- •NYHA functional class I-IV heart failure.
- •Diabetics.
- •Known pregnancy or positive pregnancy test.
结局指标
主要结局
28-day visual analog scale diary (one for each day for 4 weeks) at baseline and at conclusion of 6 months
次要结局
- Gene array analyses
- Proteomics
- Short-Form McGill Pain Questionnaire at study entry and at 3 and 6 months
- Physical component summary score of the SF-36 at baseline and at 3 and 6 months
- Cytokine quantification
研究者
Dan Lebovic
Associate Professor
University of Wisconsin, Madison