The Use of Oral Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo : A Randomized Controlled Trial Evaluation of the Effect on Cyst Diameter and Associated Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cyst diameter
研究概览
简要总结
Use of the oral desogestrel compared with placebo for preoperative treatment of endometrioma in the patient who underwent to surgery in next 3 months The result will be evaluated on cyst diameter, the associated pain and side effect of the oral desogestrel.
详细描述
Use of the oral desogestrel compared with placebo for preoperative treatment of endometrioma in the patient who underwent to surgery in next 3 months in Rajvithi hospital Patient will randomized in 2 group : Desogestrel and placebo After 1 months and 3 months the patient have to come to hospital to evaluate the result of study The result will be evaluated on cyst diameter, the associated pain and side effect of the oral desogestrel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Thai female and foreigner who can understand Thai language
- •Age 15-49 years
- •Diagnose as endometrioma sized more than 3 cm
- •Underwent to surgery in next 13 weeks
排除标准
- •History of endometriosis
- •Pregnancy woman
- •Contraindication for desogestrel : History of thrombotic event, Autoimmune disease,gestational trophoblastic disease
- •Ovarian endometrioma with complications : Ruptured, twisted
- •Contraindications for NSAIDs : Peptic ulcer, thrombocytopenia, liver disease
- •History of hormonal treatment for endometrioma : DMPA,OCP, GNRH agonist/antoginist
研究组 & 干预措施
Desogestrel group
Desogestrel group
干预措施: Desogestrel Oral Tablet (Drug)
Control group
Placebo
干预措施: Desogestrel Oral Tablet (Drug)
结局指标
主要结局
Cyst diameter
时间窗: 3 months after drug given
Cyst diameter is calculated by transvaginal ultrasound with calculated in the diameter of endometrimas (cm)
次要结局
- Associated pain(3 months after drug given)