Comparing the Safety and Efficacy in the Use of Dienogest, Leuprolide Acetate, DMPA and Combined Oral Contraceptive Pills (Microgynon) on Endometriosis Patients After Conservative Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- beta estradiol level
研究概览
简要总结
The goal of this clinical trial is to compare safety and efficacy in endometriosis patient after conservative surgery. The main question[s] it aims to answer are:
- Health-related quality of life (HRQoL)
- VAS score
- Beta estradiol
- TNF Alpha
- Adnexal mass recurrence
Participants will be randomized into 4 groups, each group will receive:
- Leuprolide Acetate injection/month
- Dienogest 2 mg/day
- COC (mycrogynon)/day
- DMPA injection 150mg/month Researcher will compare the efficacy and safety in the assigned group.
详细描述
- Beta estradiol level is measured in the serum, before and after treatment
- TNF alpha is measured in the serum, before and after treatment
- Evaluation of HRQoL using the Endometriosis Health Profile-30 (EHP-30)
- VAS score will be recorded before and after treatment
- Adnexal massa recurrence evaluation using USG
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient post surgical removal of endometriosis cyst Willing to participate
排除标准
- •Use of any hormonal therapy for endometriosis within the previous 16 weeks.
- •History of severe adverse drug reactions or hypersensitivity to steroid hormones.
- •Failure of previous treatment with COC, DMPA used in this study.
- •There are contraindications to the use of Leuprolide Acetate, COC, DMPA or Dienogest, such as a history or complications of thrombosis/embolism, stroke, Diabetes Mellitus, liver cirrhosis or other liver function disorders, breast, ovarian and endometrial malignancies.
研究组 & 干预措施
Leuprolide Acetate
Leuprolide Acetate, brand name Tapros 3.75 mg, injected intramuscularly every month for 3 months
干预措施: Leuprolide (as Leuprolide Acetate) (Drug)
Dienogest
Dienogest 2 mg, brand name Nelandoz 2mg, administered orally, every day for 3 months
干预措施: Dienogest (Drug)
Depot medroxyprogesterone acetate
Depot medroxyprogesterone acetate, brand name Depo Provera 150mg/ml, injected intramuscularly, every month for 3 months
干预措施: Depo Medroxyprogesterone acetate (Drug)
Combined Oral Contraceptive
Levonogestrel 150 mcg + etinilestradiol 30 mcg, brand name Mycrogynon, administered orally, every day for 3 months
干预措施: Levonogestrel + etinilestradiol (30 mcg, brand name Mycrogynon) (Drug)
结局指标
主要结局
beta estradiol level
时间窗: 0 and 12 weeks of treatment
Measuring beta estradiol level on the serum
TNF alpha level
时间窗: 0 and 12 weeks of treatment
Measuring TNF alpha level on the serum
次要结局
- Mass recurrence(0 and 12 weeks of treatment)
- VAS score(0 and 12 weeks of treatment)
- health-related quality of life (HRQoL)(0 and 12 weeks of treatment)
研究者
Yuli Trisetiyono
Principal Investigator
Universitas Diponegoro