JPRN-jRCT1051190028已完成4 期
Comparison of postoperative administration between dienogest and ultra low dose estrogen and progesterone tablet for suppressing recurrence of ovarian endometriomas: A randomized study - ENDOMETRIOSIS study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
In this study, patients who had undergone endometriosis surgery were treated with Dienogest and Lunabell tablets ULD for prevention of recurrence, and their preventive efficacy and safety were compared. 35 patients were randomly assigned, and data were collected from 18 patients in the Dienogest group and 17 patients in the Lunabell tablets ULD group, which were statistically analyzed. The cumulative 2-year postoperative recurrence rate was 6% in the Dienogest group and 12% in the Lunabell tablets ULD group
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 50age old（—）
- 性别
- Female
入选标准
- •1. Patients who had undergone laparoscopic surgery for ovarian endometrioma at Osaka University Hospital, Minoh City Hospital or Toyonaka Municipal Hospital
- •2. Patients who consent to this study in writing
- •3. Patients who do not want to become pregnant during this study period
- •4. Patients subject with more than 20 years old and not more than 50 years old
排除标准
- •1. undiagnosed genital bleeding
- •2. pregnant, probably pregnant or lactating
- •3. allergic to ingredient of dinagest tablets or LUNABELL tablets ULD
- •4. patients who want to become pregnant
- •5. estrogen dependent malignant tumor (e.g. breast cancer, endometrial cancer), cervical cancer or suspected to have those diseases
- •6. thrombophlebitis, pulmonary embolism, cerebrovascular accident and coronary artery disease, or past history of those diseases
- •7. more than 35 years old and smoke more than 15 cigarettes
- •8. migraine with aura (e.g. fortification spectrum etc.)
- •9. valvular disease with pulmonary; hypertension or atrial fibrillation valvular disease with past history of subacute infectious endocarditis
- •10. diabetes with vascular disease (diabetic nephropathy, diabetic retinopathy etc.)
- •11. primary cause of thrombosis
- •12. antiphospholipid antibody syndrome
- •13. within 4 weeks before surgery, within 2 weeks after surgery, within 4 weeks after delivery, or long-term bed rest
- •14. severe liver damage
- •15. liver tumor
- •16. lipid metabolism abnormality
- •17. hypertension (except mild hypertension)
- •18. otoscleosis
- •19. past history of jaundice, persistent pruritus or herpes during pregnancy
- •20. probably in the middle of bone growth
- •21. patients who are judged ineligible by doctor in charge for other reasons
研究者
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