Evaluation of a Subcutaneous Progestogen Implants in the Medical Management of Painful Endometriosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Global satisfaction
研究概览
简要总结
Endometriosis is a chronic relapsing disease characterized by the presence and proliferation of endometrial glands and stroma outside the uterus. This is a serious disease, widespread, difficult to live with for the patients, but also difficult to treat for practitioners who take care of these patients. It affects 1.6% of the general population, but its incidence is 10 times higher (up 40%) in patients with infertility. It occurs mainly by complex chronic pelvic pain and a negative influence on fertility.
It is a disease whose complexity can be explained to four levels. Firstly, through its extremely polymorphic character with intraperitoneal superficial forms, ovarian forms and deep sub-peritoneal forms.
Secondly by the plurality of the main symptoms which are individually non-specific and the frequency and / or intensity is not correlated with the severity of the disease. This non-specificity of symptoms partially explains the long lead misdiagnosis, which vary by 5 to 11 years.
Thirdly, by its prevalence which seems very high and largely underestimated. If its precise estimate in the general population is so complicated, it seems very high in many studies of patients supported surgically for gynecological reasons. These very large prevalence figures are observed when some consultations support the hypothesis of a widespread and probably insufficiently evaluated disease.
Lately by its management, insufficiently amended, for which there is currently only a few scientifically supported recommendations.
Chronic pain caused by the disease associated with altered sexuality to a loss of fertility significantly impacts the quality of life of patients.
详细描述
Investigators propose a randomized trial comparing two medical alternatives: a continuous monophasic type of estrogen-progestin oral treatment of second generation versus the establishment of an etonogestrel contraceptive implant type.
Are excluded from this study certain absolute surgical indications. Patients, by consenting to participate in the study, choose a medical care, which means not to be operated immediately. They are clearly informed about the various possible treatment alternatives. The benefits and risks of surgery and medical treatment they are explicitly presented. At any time during the study, patients who wish may discuss again a surgical treatment with their physician and stop the study drug if the decision of an intervention is taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Between 18 and 45 years old
- •with a painful symptomatic endometriosis
- •with symptoms evolve for more than 6 months
- •diagnosis based on clinical and radiological criteria : pain in the examination and/or palpation of endometriosis lesion(s) and lesion(s) objectified by MRI performed and interpreted by a radiologist referent dating less than three months at the time of inclusion
- •no history presenting therapeutic surgery for endometriosis
- •Accepting medical management
- •without hormonal treatment (oestroprogestative, progestative or Luteinizing Hormone-Releasing Hormone (LHRH) analog) since at least 15 days
- •No family history of deep venous thromboembolic disorders
- •No abnormalities of hemostasis known
- •Not pregnant at inclusion visit
排除标准
- •Patient with a strict indication for surgery (ureteral disease with renal impact, digestive disease with occlusion, infertility with desire for immediate pregnancy, ovarian cyst ≥ 4cm)
- •reproductive upper tract infections
- •with one or more varicose veins
- •with one or more breast abnormalities (ACR 3 or more)
- •with contraindication for one of two treatments
- •with contraindication for RMI
- •taking drug treatment that could alter the concentration of the study treatments
研究组 & 干预措施
Implant
Subcutaneous insertion of an progestative implant containing 68mg of etonogestrel
干预措施: Nexplanon® (Device)
Oral treatment
Continuous oral administration of second generation monophasic oestro-progestative (ethinyl-oestradiol)
干预措施: Minidril®/Leeloo® (Drug)
结局指标
主要结局
Global satisfaction
时间窗: 6th month of treatment
Global satisfaction evaluated by the SATMED-Q® satisfaction score at 6th month.
次要结局
- Sex life impact(6th and 12th month)
- Pain evaluation(6th and 12th month)
- Quality of life score(6th and 12th month)
- size of lesions(Day 1 and 12th month)
- Localisation of lesions(Day 1 and 12th month)
- Incidence of treatment-emergent adverse events (safety and tolerability)(3rd, 6th, 9th and 12th month)
- Daily life impact(6th and 12th month)
- Evaluation of dysmenorrhea, dyspareunia and pelvic pain(6th and 12th month)
- Number of lesions(Day 1 and 12th month)