CTRI/2016/03/006781 [Registered on: 31/03/2016] Trial Registered Prospectively
Last Modified On:
15/11/2018
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Medical Device
Study Design
Other
Public Title of Study
Clinical registry to evaluate safety, tolerance, and performance of Fiona™ Levonorgestrel – Releasing Intrauterine System.
Scientific Title of Study
An open label, post marketing, single arm, clinical registry to evaluate safety, tolerance, and performance of Fiona™ Levonorgestrel – Releasing Intrauterine System.
Ashadeep Multi Specialty Hospital and Research Centre
Room-Operation Theater & Doctor Consulting Room of Gynaecology Department,
5/C/28,Vivekanandnagar,Nr,
Hathijan, Ahmedabad 382445
Ahmadabad
9824066916
ashadeepmhospital@gmail.com
Dr Sonia R Chandnani
Bombay Maternity and surgical hospital
Room No.202, Gynaec OPD, 2nd floor, bhagawati ashish-2, above new janta ice-cream, prem prakash circle, city light main road, surat 395007 gujarat india Surat
912612253954
yourgynehelpline@gmail.com
Dr Indu Taneja
Fortis Escorts Hospital
Fortis Escorts Hospital
Neelam Bata Road, Faridabad-121001
Haryana, India
Faridabad
9818590029
Indu.taneja@fortishealthcare.com
Dr Urvashi Prasad Jha
Fortis Flt Lt Rajan Dhall Hospital
Fortis Flt.Lt Rajan Dhall Hospital Sector-B, Pocket-1,
aruna Asaf Ali Marg, Vasant Kunj,New Delhi-110070
New Delhi
Reversible long term contraception and willing to rely on the Intrauterine Contraceptive Device (IUCD)
Intervention / Comparator Agent
Type
Name
Details
Intervention
Fiona™ Levonorgestrel – Releasing Intrauterine System
FionaTM is an implantable Hormone Releasing Intrauterine Device
Comparator Agent
Not Applicable
No Comparator Agent in this study
Inclusion Criteria
Age From
19.00 Year(s)
Age To
40.00 Year(s)
Gender
Female
Details
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
ExclusionCriteria
Details
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 – 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.
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 pregnancies
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)
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.
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)
Target Sample Size
Total Sample Size="300" Sample Size from India="300"
Meril Endo-Surgery Pvt. Ltd is sponsoring the MES/Fiona-1 study. This study is an open label, post marketing, single arm, clinical registry to evaluate safety, tolerance, and performance of Fiona™ Levonorgestrel – Releasing Intrauterine System. This is a research conducted as a post marketing clinical study, which aims to evaluate an existing and well established medical device to prevent pregnancy (provide contraception) in a long-term.It can be used in idiopathic menorrhagia and protection from endometrial hyperplasia during estrogen replacement therapy.
