Impact vs. Dienogest: A Combined Oral Contraceptive in the Size of Endometriomas in Women With Diameters Smaller Than 4 Centimeters Thereof, at University Hospital Fundación Santa Fe de Bogota, Between the Years 2015-2017
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- the change from baseline in the size of the endometriomas, as determined by the diagnostic tool ultrasound, subsequent to drug treatment
研究概览
简要总结
Project Summary Endometriosis is a disease with a high prevalence that primarily affects women of childbearing age. This condition brings an important physical and emotional burden on sufferers and this is why it requires proper and timely medical management. At present there are several first-line drugs available for the management of symptoms and disease control. In the world literature we have reported several studies that demonstrate the effectiveness of different groups of drugs such as oral contraceptives, progestins, GnRH analogues and danazol. Within the available scientific evidence it has been extensively described the benefits of the new progestins Dienogest, demonstrating a favorable safety profile and efficacy along with a significant reduction of the symptoms of the disease by its anti-inflammatory, and antiproliferative antiagiogénicas in the endometrial tissue . However, although the therapeutic properties of this drug are known, studies are needed to compare its effectiveness with the effectiveness of other therapeutic agents as oral contraceptives. That is why the main objective of this study is to evaluate the impact of Dienogest to 2 mg / day compared with a combined oral contraceptive (levonorgestrel + ethinyl estradiol) in the size of the endometriomas diagnosed by transvaginal ultrasonography in 50 women having diameters less than 4 centimeters of the same, which medical management will be given for one year at the University Hospital Fundación Santa Fe de Bogota. The study was conducted by a clinical trial, randomized, single-blind by the observer. The results will be analyzed and the findings in the study will serve as a tool to define new therapeutic conduct in the management of endometriosis.
详细描述
Problem and Justification:
Endometriosis is defined as the presence of endometrial tissue outside the uterine cavity, which induces a chronic inflammatory response.
It is a common problem that affects about 6-10% of women of reproductive age, 50-60% of women and adolescents with pelvic pain and nearly 50% of women with infertility. it is characterized by abdominal pain, back pain, pain during sex, dysfunctional uterine bleeding and infertility. Being a common condition among women of childbearing age, which often goes undiagnosed for many years. This delay in diagnosis is due to the variability of symptoms and the lack of tools for accurate diagnosis available for primary care, which is a major burden on the quality of life of patients symptomatic.
The diagnosis of endometriosis should start with clinical history and physical examination and transvaginal ultrasound has proven useful in the diagnosis of ovarian endometriomas and its differential diagnosis with other ovarian masses.
Histologically the lesions identified in endometriosis resemble endometrial tissue in places outside the endometrium, which proliferates in response to hormonal changes that occur with menstruation, causing increased pain and bleeding.
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 (Investigator)
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
- •Women Of childbearing age (this period), without desire for fertility, without treatment for endometriosis in the past three months, with ultrasound diagnosis of endometrioma (unilateral or bilateral) minor diameter to 4 centimeters. Those who do not go to surgical procedure and who choose or who are instructed to follow a medical management. No contraindications to oral contraceptive use, rating and eligibility criteria of WHO 1 (no restriction can be used in all circumstances) or 2 (the advantages of using the method generally outweigh the risks, usually can be used) . And who they entered the University Hospital Fundación Santa Fe de Bogota.
排除标准
- •Intercurrent cardiovascular-disease or a history of it (arterial thrombosis or current or previous venous thromboembolism, thrombophilic genetic disease), smoking, obesity, kidney failure, SLE, diagnosed or suspected autoimmune diseases and hypertension.
- •If you have a history of migraine accompanied by eg visual symptoms, slurred speech or weakness or numbness in any part of the body.
- •If you have diabetes mellitus with blood vessels. If you have or have had pancreatitis (inflammation of the pancreas) associated with high levels of fatty substances in the blood.
- •If you have jaundice (yellowing of the skin) or severe liver disease. If you have or have had a cancer that may grow under the influence of sex hormones (eg of the breast or genitals).
- •If you have or have had a liver tumor, benign or malignant. If you have any unexplained vaginal bleeding. If you are pregnant or think you might be. If you are hypersensitive (allergic) to ethinyl estradiol, levonorgestrel, dienogest or any other part.
研究组 & 干预措施
Dienogest
the patient handling with 2 mg dienogest / day.
干预措施: Dienogest (Drug)
Levonorgestrel + ethinylestradiol
The patient handling with levonorgestrel + ethinylestradiol (0,10 mg - 0,02 )
干预措施: Levonorgestrel (Drug)
结局指标
主要结局
the change from baseline in the size of the endometriomas, as determined by the diagnostic tool ultrasound, subsequent to drug treatment
时间窗: one year
The change from baseline in the size of the endometriomas, as determined by the diagnostic tool of ultrasound in a year of contraceptive treatment
次要结局
未报告次要终点
研究者
RICARDO RUEDA
gynecologist
Fundación Santa Fe de Bogota