An Open-label, Prospective, Multicentric, Single-arm,Phase IV Study to Assess the Efficacy and Safety ofLevonorgestrel Intrauterine System (Emily) in Indian Womenwith Dysfunctional Uterine Bleeding

HLL Lifecare Limited0 个研究点目标入组 75 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Indian women >30 and <50 years of age suffering from DUB
•2. Married and having at least one normal living child
•3. Must be having a history of excessive menstrual bleeding for a minimum of last 3 cycles (as evidenced by a baseline Pictorial Blood Assessment Chart [PBAC] score1 of 100 or more)
•4. Not using any other hormonal method of contraception
•5. Willing to use IUS for the treatment of DUB
•6. Not contemplating pregnancy during the course of study
•7. Must be willing to give written informed consent and comply with the study procedures
•8. Expect to continue living in an area accessible to the study center for the duration of the study

•. Known or suspected pregnancy
•2. Last delivery or abortion within the past 3 months
•3. Intermenstrual bleeding
•4. Postmenopausal bleeding (bleeding after more than one year from the last menstrual period)
•5. Demonstrable pathological cause for DUB including pelvic inflammatory disease and
•untreated acute cervicitis or vaginitis
•6. Congenital abnormality of the uterus
•7. Abnormal PAP smear report
•8. Presence of diabetes mellitus (subjects with a random blood sugar [RBS] level above
•9. Uncontrolled hypertension defined as BP _140/90 mm Hg in a supine position after resting
•for 15 minutes)
•10. History or presence of incapacitating migraine
•11. History of cerebrovascular disease and coronary artery disease
•12. Known or suspected tumors of liver, kidney, ovary, uterus, cervix and breast
•13. History of thrombophlebitis or thromboembolism in the past
•14. On any prohibited medication (hepatotoxic drugs, herbal or ayurvedic products) during the
•past one month
•15. On immunosuppressive treatment
•16. Known hypersensitivity to micronized progesterone or silicone rubber or any component of this product
•17. Thyroid Stimulating Hormone (TSH) levels <0.4 IU/mL and >7 IU/mL

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