None listed
Conditions
Interventions
Intervention1: Fionaâ?¢ Levonorgestrel â?? Releasing Intrauterine System: FionaTM is an implantable Hormone Releasing Intrauterine Device
Control Intervention1: Not Applicable: No Comparator Agent in
Sponsors
Meril EndoSurgery Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 b. Number of ectopic pregnanciesTimepoint: 30±10 days, 3 months (90 days ± 15 days) 6 months (180 days ± 30 days) 1 year (12 months ± 1 month) 2 year (24 months ± 1 month)j 3 year (36 months ± 1 month) 4 year (48 months ± 1 month) 5 year (60 months ± 1 month) | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerance: Proportion of population reporting appearance of new symptoms anticipated or suspected to be related to the insertion of study device at 30 days, and 60 days after the implantation and retention of study device PK Endpoints: Demonstration of Levonorgestrel levels in blood up to 5 years.Timepoint: 30±10 days, 3 months (90 days ± 15 days) 6 months (180 days ± 30 days) 1 year (12 months ± 1 month) 2 year (24 months ± 1 month)j 3 year (36 months ± 1 month) 4 year (48 months ± 1 month) 5 year (60 months ± 1 month) | — |
Countries
India
Contacts
Public ContactDr Ashok Thakkar
Meril Life Sciences Pvt. Ltd
Outcome results
None listed