CTRI/2016/03/006781已完成4 期
An open label, post marketing, single arm, clinical registry to evaluate safety, tolerance, and performance of Fionaâ?¢ Levonorgestrel â?? Releasing Intrauterine System. - Fiona-1
Meril EndoSurgery 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
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Subjects willing to participate in the study by signing informed consent form.
- •2. Healthy females, between age of 19 and 40 years at the time of enrolment.
- •3. Regularly sexually active and in mutually monogamous relationship for at least 6 months at study entry.
- •4. Subjects who are willing to opt for reversible long term contraception and willing to rely on the Intrauterine Contraceptive Device (IUCD) as the method of contraception during study participation
- •5. History of regular menstrual cycle between 3-5/21 days to 3-5/35 days.
- •6. Willing to comply with study visit schedule and assessments
排除标准
- •1. Currently breastfeeding subjects.
- •2. Subjects with positive pregnancy test, whose pregnancy has not been terminated.
- •3. History of ectopic pregnancy or hydatidiform mole without a subsequent intrauterine pregnancy.
- •4. History of trophoblastic disease.
- •5. Acute pelvic inflammatory disease or a history of chronic pelvic inflammatory disease without subsequent intrauterine pregnancy.
- •6. Subjects with Migraine Grade III or Psychological disorders.
- •7. Positive HIV test, VDRL test or Gonorrhoea.
- •8. History of cervical or vaginal infection unless successfully treated and considered clinically cured for at least 14 days prior to study entry.
- •9. Postpartum or post â?? abortion endometritis unless symptoms are resolved at least 4 weeks prior to study entry.
- •10. History of repeated threatened abortion, retention of placenta or severe postpartum haemorrhage.
- •11. Abnormal PAP smear test.
- •12. History or suspicion of malignancy of genital track e.g. cervix, ovary or endometrium or of breast cancer unless proven otherwise.
- •13. Structural defects of the female reproductive organs including uterus, both ovaries, both fallopian tubes and vagina, any kind of ovarian cysts or hydrosalpinx or endometriosis, or any other abnormality of the uterus resulting in distortion of the uterine cavity or cervical canal incompatible with insertion
- •14. Body habitus or history of lower genital tract abnormalities or prior surgery that may limit proper visualization of cervix and / or use of operative instruments.
- •15. Known or suspected allergy to levonorgestrel or hypersensitivity to any component of IUCD.
- •16. Bleeding diathesis (inherited or acquired) or use of anticoagulants within 30 days prior to study entry.
- •17. Subject or her spouse considering the use of additional method of contraception in addition to the Study Device.
研究者
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