A prospective, multi-centre, open-label, double arm, parallel, bioequivalence, comparative study to assess the efficacy and safety of Levonorgestrel – Releasing Intrauterine Systems
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 5
- 主要终点
- 1. Proportion of failure of contraception as indicated by events of pregnancies inpresence of study device or due to auto-expulsion of study device
研究概览
简要总结
Title of Study: A prospective, multi-centre, open-label, double arm, parallel, bioequivalence, comparative study to assess the efficacy and safety of Levonorgestrel – Releasing Intrauterine Systems
Study Design: A prospective, multi-centre, open-label, double arm, parallel, bioequivalence, comparative study to assess the efficacy and safety of Levonorgestrel – Releasing Intrauterine Systems
Indications: Fiona is intended for contraception. It can also be used in idiopathic menorrhagia and protection from endometrial hyperplasia during estrogen replacement therapy.
Number of overall Subjects: Total minimum 140 Subjects: Group A: Minimum 70 Subjects of Meril’s Fiona Hormonal IUD. Group B: Minimum 70 Subjects of predicate levonorgestrel intrauterine
Number of Subjects for pharmacokinetic evaluation: Total minimum 50 Subjects: Group A: Minimum 25 Subjects of Meril’s Fiona Hormonal IUD. Group B: Minimum 25 Subjects of predicate levonorgestrel intrauterine.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects willing to participate in the study by signing informed consent form.
- •Healthy females between the ages of 19 and 40 years at the time of enrolment.
- •Regularly sexually active and in mutually monogamous relationship for atleast 6 months at study entry.
- •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.
- •History of regular menstrual cycle between 3-5/21 days to 3-5/35 days.
- •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.
- •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 Gonorrhea.
- •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-abortion endometritis unless symptoms are resolvedat least 4 weeks prior to study entry.
- •11.Abnormal PAP smear test.
- •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 surgerythat 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.
结局指标
主要结局
1. Proportion of failure of contraception as indicated by events of pregnancies inpresence of study device or due to auto-expulsion of study device
时间窗: Time Frame: 1 month ± 10 days, 6 months ± 30 days, 1 year ± 30 days
A. Number of Intra-uterine pregnancies
时间窗: Time Frame: 1 month ± 10 days, 6 months ± 30 days, 1 year ± 30 days
B. Number of ectopic pregnancies
时间窗: Time Frame: 1 month ± 10 days, 6 months ± 30 days, 1 year ± 30 days
次要结局
- 1.Proportion of failure of contraception as indicated by events of pregnancies in presence of study device or due to auto-expulsion of study device(A. Number of Intra-uterine pregnancies)
研究者
Dr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd