A RANDOMISED CLINICAL TRIAL OF LEVONORGESTREL INTRA UTERINE SYSTEM WITH OR WITHOUT METFORMIN FOR TREATMENT OF ENDOMETRIAL HYPERPLASIA WITHOUT ATYPIA

Postgraduate institute of medical education and research0 个研究点目标入组 51 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Histologically confirmed endometrial hyperplasia without atypia on EB.
•2.Over 18 years of age.
•3.USG pelvis suggesting the absence of extrauterine malignancy and lesions distorting the endometrial cavity.
•4.No hypersensitivity or contraindications for Emily and metformin.
•5.Ability to comply with endometrial biopsies at specified intervals
•6.Negative serum or urine pregnancy test in pre-menopausal women and women < 2 years after the onset of menopause
•7.Understand study design, risks, and benefits and have signed informed consent

•1.Creatinine (Cr) > 1.5 mg/dL ,Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2 x upper limit of normal (ULN),FBS >126mg/dl or PPBS >200mg/dl.
•2.Currently receiving progestin therapy (local, topical, or systemic) for greater than 1 month.
•3.Mixed histology including clear cell, serous, undifferentiated or sarcomatous elements
•4.History of hypersensitivity to metformin or history of discontinuation secondary to attributed adverse effects.
•5.Chronic use of cimetidine.
•6.Pregnant or lactating
•7.Recent ( < 4 weeks) active, documented, cervical infection or active PID.
•8.Patients with endometrial hyperplasia with atypia on EB.
•9.Congenital or acquired uterine anomaly which distorts the uterine cavity
•10.Immune suppressed individuals due to inceased risk of infection.
•11.Contraindications to both Metformin and progestins.
•12.Known diabetics on treatment.
•13.Patients not willing to participate in the study.

发起方