A Randomized Double-Blind Placebo-Controlled Trial to Assess the Effectiveness of Low-Dose Naltrexone in Combination With Standard Treatment in Women With Chronic Pelvic Pain Secondary to Endometriosis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Pain Score Area Under the Curve (AUC)
研究概览
简要总结
The purpose of this study is to determine if the addition of Low Dose Naltrexone to standard endometriosis treatments will improve patient reported endometriosis associated pain.
详细描述
The central hypothesis of the research study is that low dose naltrexone (LDN), in combination with hormonal suppression of endometriosis (standard of care), will lead to significant improvement of endometriosis-related pain.
The proposal seeks to:
- determine if the addition of LDN to standard endometriosis treatments will improve patient- reported endometriosis associated pain using daily Visual Analogue Scale (VAS) scores and
- measure the impact of treatment on quality of life as measured by validated questionnaires including the Endometriosis Health Profile-30 (EHP30) and the Patient's Global Impression of Change (PGIC).
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal female ages 18 to 45 years old on the day of signing informed consent.
- •Must agree to use only study-specific analgesic medications during the study and is not known to be intolerant to them.
- •Diagnosed with endometriosis and has had, within the last 10 years prior to signing the informed consent, surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis.
- •Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis during the study period.
- •Agrees to use contraception if not surgically sterile during the entire study.
- •Patients using oral contraceptives, LARCs and/or GnRH agonists/antagonists for contraception and/or management of endometriosis, with a stable regimen, will be able to continue in the study, however, women using oral contraceptives and GnRH agonist/antagonists will be switched to Norethindrone acetate during the 1-2 week run-in period as prescribed by principle investigator.
排除标准
- •Women that are pregnant, breastfeeding or trying to conceive.
- •Patients with chronic daily narcotic use and any chronic pain or frequently reoccurring pain condition, other than endometriosis, that is treated with opioids or requires analgesics for more than 7 days per month.
- •Patients with abnormal liver function tests (greater than 3x normal limit) in the past year or history of liver disease. Routine screening of liver function is not required.
- •Non-English speaking or inability to read and understand English secondary, in part, to the need to read and report daily results in English.
- •Undiagnosed vaginal bleeding
- •Patients with history of opioid, illicit drug or alcohol abuse
- •Patients currently taking thioridazine
- •Patients with a history of suicidality
- •Patients with current or history of unstable depression or other psychiatric disorder who, by PI judgement, are unstable or not well controlled
- •Known, suspected or history of cancer of the breast
- •Active deep vein thrombosis, pulmonary embolism or history of these conditions
- •Active or recent arterial thromboembolic disease (e.g., stroke, myocardial infarction)
研究组 & 干预措施
Low-Dose Naltrexone
12-week intervention period of 4.5 mg daily naltrexone in combination with standard treatment of 5-15 mg daily norethindrone acetate
干预措施: Naltrexone (Drug)
Low-Dose Naltrexone
12-week intervention period of 4.5 mg daily naltrexone in combination with standard treatment of 5-15 mg daily norethindrone acetate
干预措施: Norethindrone Acetate (Drug)
Placebo
12-week intervention period of daily placebo in combination with standard treatment of 5-15 mg daily norethindrone acetate
干预措施: Norethindrone Acetate (Drug)
Placebo
12-week intervention period of daily placebo in combination with standard treatment of 5-15 mg daily norethindrone acetate
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Score Area Under the Curve (AUC)
时间窗: 12 weeks
Pain is reported daily using the Visual Analog Scale, a 100mm horizontal line on which the patient's pain intensity is represented by a point between the extremities of 0 (no pain) and 100 (worst pain). The final outcome measure will be calculated as area under the curve from randomization through 12-weeks of intervention. AUC was calculated using the trapezoid rule. Calculated AUC per subject across this 12-week period can range from 0 - 8300.
次要结局
- Ibuprofen Use(12 weeks)
- Oxycodone Use(12 weeks)
- PGIC Score (Dyspareunia)(4, 8, 12 and 16 weeks)
- PGIC Score (Nonmenstrual Pelvic Pain)(4, 8, 12 and 16 weeks)
- EHP-30 Score(Baseline, 4, 8, 12, and 16 weeks)
- PGIC Score (Painful Periods)(4, 8, 12 and 16 weeks)
研究者
Kristin Riley, MD
Asst. Professor of Obstetrics and Gynecology
Milton S. Hershey Medical Center