NCT02213081已完成4 期
Phase IV Pilot Study of Ulipristal Acetate for Treatment of Endometriosis-related Pelvic Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Pelvic Pain
研究概览
简要总结
The aim of this research is to assess the benefit of a medication (ulipristal) for alleviation of symptoms in women with chronic, endometriosis-related pelvic pain.
详细描述
This study will assess the use of a medication to improve symptoms of chronic, endometriosis-related pelvic pain among women who did no achieve relief with prior surgical and medical treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of endometriosis with surgical confirmation via laparoscopy performed within 3 years prior to study enrollment
- •English-speaking reproductive-age women (18-50yo) with regular, cyclical menses
- •Treatment-refractory endometriosis, as defined by persistent or recurrent pelvic pain following one or more treatments involving surgery and/or hormonal treatment
- •Dysmenorrhea and chronic pelvic pain for a least one week out of the month during past 5 months or longer
- •Endometrial biopsy before and after intervention
- •Adequate organ and marrow function as defined below:
- •leukocytes ≥ 3,000/microliter
- •absolute neutrophil count ≥ 1,500/microliter
- •platelets ≥ 100,000/microliter
- •total bilirubin within normal institutional limits
- •Liver function tests ≤ 2.5 X institutional upper limit of normal
- •creatinine within normal institutional limits
- •Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •Undiagnosed vaginal bleeding
- •Abnormal results from endometrial biopsy
- •Presence of ovarian cysts ≥ 3 cm
- •Pregnancy
- •Refusal to adhere the birth control strategy of the study (use of a combination of a condom and a vaginal sponge during each intercourse while on ulipristal, plus one month before the onset and one month after the completion of ulipristal therapy)
- •Women taking digoxin, dabigatran or etexilate due to interference of ulipristal acetate with the concentration of these substances bound by plasma proteins.
- •Women taking moderate to potent inducers of hepatic metabolism (e.g. erythromycin, ketoconazole, ritonavir, nefazodone).
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ulipristal.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active pulmonary, cardiac, renal, hepatic or thromboembolic disease, infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Ulipristal
Experimental
1 patient with chronic, endometriosis-related pelvic pain refractory to medical and/or surgical therapies will receive 15mg ulipristal every other day (three times a week- Monday, Thursday, Saturday) for three months.
干预措施: Ulipristal (Drug)
结局指标
主要结局
Pelvic Pain
时间窗: Patients will document self-reported daily pain scores via visual analogue scale(0 to10 where 0 is no pain and 10 is worst pain)for one month prior to starting treatment (1 month),while receiving treatment (3 months) after cessation of treatment (1 month)
Scores were collected daily and averaged together for each period
次要结局
- Vaginal Bleeding(5 months)
- Pain With Sexual Intercourse(5 months)
研究者
研究点 (1)
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