Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Evaluation of endometriosis foci regression
研究概览
简要总结
This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.
详细描述
Patient recruitment will be carried out on a prospective basis and based on the group of patients from the private Medical Clinics in 4 cities (Campina Grande - Pb, São Paulo - SP, São José dos Campos - SP and Brasilia-DF). The study will include 70 adult female patients of menstrual age, pre-menopause (18 to 45 years old), who seek medical treatment to alleviate complaints related to endometriosis. The selected patients will be randomly allocated into two groups, in a 1:1 ratio. Control Group (n=35) - treatment with oral Dienogest - and Test Group (n=35) - Implantation of Gestrinone pellets. Follow-up visits will be scheduled after 1 week and 1, 3, 6, 9 and 12 months of initiation of therapy. Therapies will be compared with respect to the effects on the severity of dysmenorrhea, dyspareunia and non-cyclical pelvic pain (Verbal Scale and Visual Analogue Scale), level of Uterine Bleeding assessed by PBAC, systemic effects (hormonal, hepatic, lipid profile, cell concentration red, clotting factor - assessed through blood tests), endometriosis lesions, endometrial thickness (transvaginal ultrasound), body composition (bioimpendance test), quality of life (EHP30) and sexual function (female sexual function index ) - FSFI. Data analysis will be carried out using validated statistical software. Chi-square or Fisher&#39;s exact tests will be used to compare qualitative variables, while independent t-tests will be used to compare quantitative variables between the two groups. Analysis of variance with repeated measures will be used to compare the average pain intensity over time. The significance level for all tests will be p<0.05.
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
- Single (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
- •Adult female patients of menstrual age, pre-menopause (18 to 45 years old), who seek medical treatment to alleviate complaints related to endometriosis, who are not undergoing other therapies to treat them.
- •Patients must have a diagnosis of Grade 1 or 2 endometriosis assessed by imaging tests (ultrasound with bowel preparation and/or MRI of the pelvis with bowel preparation)14, have a BMI of up to 25kg/m2, and weigh between 50 and 70kg.
排除标准
- •Pregnant patients (supporting test must be presented)
- •Breastfeeding women, using other hormonal contraceptive methods or copper or silver IUDs, who have polycystic ovaries, and/or hyperandrogenism.
- •Patients using medications that may interfere with androgen metabolism within 4 weeks of screening or during the study.
- •Patients with a history of liver disease, cardiovascular disease (myocardial infarction, unstable angina or heart failure), active hepatitis, liver neoplasia or renal failure
- •Patient who are scheduled for surgical treatment during the study period.
研究组 & 干预措施
Implantable Gestrinone
Implantation of Gestrinone pellets - Eligible patients will undergo implantation of Gestrinone pellets (bio meds Brasil, Florianópolis, Brazil) subcutaneously, in the gluteal region, using aseptic technique under local anesthesia. Patients will use 1.6mg/kg of weight to treat endometriosis. A second implantation procedure will be performed 6 months after the first, allowing evaluation of the effects of the therapy over a period of 12 months.
干预措施: Implantable gestrinone (Drug)
Oral Dienogest
Patients will receive the medication to be administered orally at 2mg daily for 12 months.
干预措施: Oral Dienogest (Drug)
结局指标
主要结局
Evaluation of endometriosis foci regression
时间窗: Pre-treatment, 6 and 12 months
Assessment of endometriosis lesions and endometrial thickness on Transvaginal Ultrasound with bowel preparation and/or MRI of the pelvis with bowel preparation - All patients will be referred, at pre-treatment and at 6 and 12 month visits, to undergo transvaginal ultrasound to assess the presence or absence of endometriotic lesions, in addition to controlling the thickness of the endometrium.
Evaluation of non-cyclical pelvic pain severity
时间窗: Pre-treatment, 1 week, 1, 3 , 6 and 12 months
Patients will be instructed to rate the intensity of pelvic pain (outside the menstrual period), at each visit after the first month of treatment, using a modified verbal scale from 0 to 3, as suggested by Biberoglu and Behrman. Patients should also rate the intensity of the symptoms using a 100 mm visual analogue scale.
Evaluation of dysmenorrhea severity
时间窗: Pre-treatment, 1 week, 1, 3 , 6 and 12 months
Patients will be instructed to rate the intensity of dysmenorrhea at each visit after the first month of treatment, using a modified verbal scale from 0 to 3, as suggested by Biberoglu and Behrman. Patients should also rate the intensity of the symptoms using a 100 mm visual analogue scale.
Evaluation of dyspareunia severity
时间窗: Pre-treatment, 1 week, 1, 3 , 6 and 12 months
Patients will be instructed to rate the intensity of deep dyspareunia at each visit after the first month of treatment, using a modified verbal scale from 0 to 3, as suggested by Biberoglu and Behrman. Patients should also rate the intensity of the symptoms using a 100 mm visual analogue scale.
次要结局
- Evaluation of quality of life(Pre-treatment, 6 and 12 months)
- Evaluation of body composition(Pre-treatment, 3 , 6 and 12 months)
- Evaluation of abnormal Uterine Bleeding (AUB)(Pre-treatment, 1, 3 , 6 and 12 months)
- Evaluation of adverse effect(Pre-treatment, 1 week, 1, 3 , 6 and 12 months)
- Evaluation of sexual function(Pre-treatment, 1 week, 1, 3 , 6 and 12 months)