Randomized Phase 2 Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Compare the mean change of serum Anti-Mullerian Hormone (AMH) level
研究概览
简要总结
Randomized phase 2 trial comparing preoperative dienogest therapy followed by surgery vs. upfront surgery to save ovarian reserve in young women with ovarian endometrioma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Unilateral ovarian endometrioma ≥ 5cm or bilateral ovarian endometriomas with any size diagnosed by ultrasonography.
- •In Patients with previous unilateral salpingo-oophorectomy (USO)
- •Unilateral ovarian endometrioma with any size is eligible
- •20 ≤ Age ≤ 45 and premenopause
- •Plan to undergo conservative surgery for endometriomas
排除标准
- •Pregnant women or women who were suspected to be pregnant
- •Women with current venous thromboembolism or history of such diseases
- •Women with current arterial disease or cardiovascular diseases (e.g. myocardial infarction, cerebrovascular diseases, or ischemic heart diseases) or history of such diseases
- •Women with current diabetes with vascular lesions or history of such diseases
- •Women with current severe liver diseases or history of severe liver diseases with abnormal liver function
- •Women with current liver tumor or history of liver tumor
- •Women with current or history of sex-hormone dependent malignant tumor or women who were suspected to have a sex-hormone dependent malignant tumor
- •Women with vaginal bleeding of unknown causes
- •Women with a history of allergic reaction to elements of DNG
- •Women with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Women whose non-compliance is expected
- •Lactation (treatment with DNG is not recommended in lactating women due to possible excretion in breast milk)
- •Any medication that could result in an excessive accumulation, impaired metabolism, or altered excretion of the study drug or might interfere with the conduct of the study or the interpretation of the results
研究组 & 干预措施
Control group
Placebo drug 1 tablet per day will be prescribed for 3months before surgery in ovarian endometrioma patients.
Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 2 months from 1month after surgery.
干预措施: Dienogest (Drug)
Control group
Placebo drug 1 tablet per day will be prescribed for 3months before surgery in ovarian endometrioma patients.
Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 2 months from 1month after surgery.
干预措施: Placebo drug (Drug)
Control group
Placebo drug 1 tablet per day will be prescribed for 3months before surgery in ovarian endometrioma patients.
Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 2 months from 1month after surgery.
干预措施: Surgery (Procedure)
Case group
Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 3months before surgery in ovarian endometrioma patients.
Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 2 months from 1month after surgery.
干预措施: Dienogest (Drug)
Case group
Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 3months before surgery in ovarian endometrioma patients.
Dienogest(DNG) 2mg 1 tablet per day will be prescribed for 2 months from 1month after surgery.
干预措施: Surgery (Procedure)
结局指标
主要结局
Compare the mean change of serum Anti-Mullerian Hormone (AMH) level
时间窗: 3 month after surgery
次要结局
- Compare the trend of mean change of serum AMH level(1 and 3 month after surgery)
- compare the surgical time (minute)(intraoperative)
- number of participants with treatment-related adverse events as assessed by CTCAE v4.0(All adverse events from randomization to postoperative 3 months)
- Compare the mean change of serum AMH level(baseline and after preoperative dienogest/placebo therapy for 3 months)
- Compare the revised American fertility society (AFS) score(At surgery)
- Brief Pain Inventory (BPI) scores(baseline, 1 month after surgery and 3 month after surgery)
- Mean change of diameter of endometrioma measured by ultrasonography after preoperative dienogest/placebo therapy for 3months(baseline and after preoperative dienogest/placebo therapy for 3 months)
研究者
Kidong Kim
Associate Professor
Seoul National University Hospital