IRCT201408133950N3已完成3 期
Effect off Microrelin (GnRH agonist) on uterine fibroma
Vice Chancellor for Research of Tehran University of Medical sciences0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 50 years(—)
- 性别
- Female
入选标准
- •Inclusion Criteria: Be a pre-menopausal woman between 18 and 50 years, have indication of surgical myomectomy due to any complain, Less than 2 myomas with the diameter of 2- 4 Cm which are totally intracavitary or have a myometrial expansion less than 50%, If of childbearing potential the subject must be practicing a non-hormonal method of contraception, BMI = 18 and = 40.
排除标准
- •Indication of emergent surgery, history of or current uterine cervical, ovarian or breast cancer, current endometrium atypical hyperplasia or adenocarcinoma, a known severe coagulation disorder, has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist,Has a history of or known current osteoporosis, abnormal hepatic function at study entry, a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study, a current (within twelve months) problem with alcohol or drug abuse, is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
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