CTRI/2024/08/072217尚未招募4 期
MES/MeriTe Cu 375-PMS Study: A Prospective, Single-arm, Open-label, Multicenter, Post-Market Surveillance Study to Evaluate the Safety and Performance of MeriTe(TM) Cu 375. - NI
Meril Life Sciences Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Healthy women aged 18-45 years of age and only female gender are enrolled in the study.
- •2.Women desired to use the MeriTe™ Cu 375 IUD as a Long Acting Reversible Contraceptive (LARC) method.
- •3.Subjects who undergo ultrasound at baseline are included in the study.
- •4.Subject must be willing and able to provide written Informed Consent by signing and dating the IRB or EC-approved Informed Consent form.
- •5.The subject is willing and able to comply with postinsertion scheduled clinical evaluations.
排除标准
- •1.Women under the age of 18 are excluded.
- •2.The subject has pregnancy or suspicion of pregnancy are not
- •advised to take IUDs.
- •3.Lactating women are excluded from the study.
- •4.Postmenopausal women are excluded from the study.
- •5. History of trophoblastic disease.
- •6.Subjects having a history of irregular menstrual cycle and infertility, ectopic pregnancies are excluded from the study.
- •7.Subjects used any long-acting injectable sex-hormone preparations within 9 months are excluded from the study
- •8.Subjects having a history of alcohol or drug abuse are excluded from the study.
- •9.The subject is diagnosed with abnormalities of the uterus, resulting in distortion of the uterus and vaginal abnormalcy (unicornuate, bicornuate, didelphys, or septate uterus).
- •10.The subject has acute pelvic inflammatory disease or current behavior suggesting a high risk for pelvic inflammatory disease is not included in the study.
- •11.Subjects having a history of post-partum endometritis or postabortal endometritis in the past 6 months are excluded.
- •12. Subjects diagnosed with anemia, valvular heart disease, Coagulation disorders, and on treatment for Anti-inflammatory are not advised to be included in the study.
- •13. Subjects having Mucopurulent cervicitis and Wilson’s disease are excluded from the study
- •Any subject who has an allergy to any component of MeriTe™
- •14.If the subject is experiencing significant post-partum bleeding and/or pain, then infection or other causes should be excluded
- •before insertion.
- •15.The subject is unwilling or unable to sign the Informed Consent Document.
- •16. Postpartum insertions should be postponed until the uterus is fully involuted. Do not insert earlier than six weeks after delivery.
- •17. Women diagnosed with AIDS should not insert IUDs unless they are clinically stable on antiretroviral therapy.
- •18. Subjects whose life expectancy is less than 5 yrs of age such as cancer patients are excluded from the study.
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