JPRN-jRCTs071180042已完成未知
The Influence on SPecific Activity of protein S and coagulation system : Dienogest and low dose estrogen-progestin for Endometriosis - SPADE study
Kato Kiyoko0 个研究点目标入组 111 人开始时间: 2019年3月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 111
研究概览
简要总结
In this study, DNG treatment had little effect on PS specific activity system, and LEP treatment lowered the total amount of PS activity and PS specific activity at 1 months after the first treatment and these effects kept until 6 months. Because of limit of the sample size, the opportunity of demonstrating that PS specific activity system have capacities of early detection of VTE was not in this study. More examinations with larger sample size are needed to confirm properties of PS activity system.
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 with treatment start plan of dienogest or low dose estrogen-progestin for endometriosis.
- •2. Female patients with more than 20 years and less than 50 years at the date of informed consent.
- •3. Patients with menstrual cycle.
- •4. Patients providing the written informed consent.
排除标准
- •1. Patients with pregnant or the possibility of pregnancy.
- •2. Patients with post partum within 4 weeks or with lactation.
- •3. Patients with abnormal genital bleeding not to be diagnosed.
- •4. Patients with the complication of malignant tumor or the suspicion of complication.
- •5. Patients with severe hepatic disorder or hepatic tumor.
- •6. Patients within 4 weeks after the operation (excluding operational duration of less than 30 min).
- •7. Patients without continuous administration for 24 weeks.
- •8. Patients with treatment history of steroidal hormones including sex hormones and GnRH agonist within the past 3 months.
- •9. Patients under anticoagulation and antiplatelet drug.
- •10. Patients with hypersensitivity to the constituents of the study drug (dienogest tablets or low dose estrogen-progestin tablets).
- •11. Patients with contraindication of Lunabell tablet LD/ULD and Yaz tablet in low dose estrogen-progestin group.
- •12. Patient who is judged to be inappropriate for study participation for any reason by the doctor.
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