| CTRI Number |
CTRI/2025/03/082696 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Hormonal Intrauterine Contraceptive Devices |
|
Scientific 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 |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MES/Fiona-Hormonal IUD, Version 2.0.0 dated 19-Apr-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt Ltd.,Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no
135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India
Valsad
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt Ltd.,Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no
135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirankumar Shetty |
| Designation |
DGM - Product Performance & Engineering Department |
| Affiliation |
Meril Life Sciences Pvt. Ltd |
| Address |
Meril Life Sciences Pvt Ltd.,Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no
135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India
GUJARAT
396191
India |
| Phone |
9743700109 |
| Fax |
|
| Email |
kirankumar.shetty@merillife.com |
|
|
Source of Monetary or Material Support
|
| Meril Endo Surgery Pvt. Ltd.
E1,E3, Meril Park, Survey No 135,2,B and 174,2, Muktanand Marg, Chala, Vapi 396191, Gujarat,
|
|
|
Primary Sponsor
|
| Name |
Meril Life Sciences Pvt Ltd |
| Address |
Near Bilakhia Stadium, Survey no 135/139,Muktanand marg, Chala,
Vapi-396191, Gujarat, India |
| Type of Sponsor |
Other [Medical Device Company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bharathi Rathi |
Bharti Rathi Hospital |
Civil Line Rd, New Radhakisan Plots, Square, Shastri Nagar, Akola, Maharashtra 444001
Akola
MAHARASHTRA |
9822666975
bharatirathi12@gmail.com |
| Dr Sejal modi |
Mother maternity & Nursing home |
Sahjanand Avenue, Naranpura Rd, near AEC Tower, AEC Char Rasta, Naranpura, Ahmedabad, Gujarat 380013
Ahmadabad
GUJARAT |
9327073897
shiv_kaumii@yahoo.com |
| Dr Hasmukh Agarwal |
Reshambai Hospital |
1st Floor, Swastik Complex, Near Rajasthan Hospital, Shahibagh, Ahmedabad, Gujarat 380004
Ahmadabad
GUJARAT |
9824045004
info@reshambhaiivf.org |
| Dr Dhaval Shah |
Saavi womens hospital |
Vishal Tower Rd, near Ishan 3, opp. Shell Petrol Pump, Anand Nagar, Prahlad Nagar, Ahmedabad, Gujarat 380015
Ahmadabad
GUJARAT |
9426897096
dr_dhavalshah@yahoo.com |
| Dr Jagruti Y Desai |
Udhna Hospital |
2nd Floor, Gynaecology dept,18 Patel Colony, B/h. Bank of Baroda, Main Road Udhna, surat-395017
Surat
GUJARAT |
9879012116
udhanahospital@gmail.com |
| Dr Chirag Patel |
Vimal hospital |
Gynaecology dept,1st floor, science City Rd, Sola, Ahmedabad, Gujarat 380060
Ahmadabad
GUJARAT |
9426897096
drcdpatel55@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Gillurkar Hospital Ethics Committee |
Approved |
| Nirmal Hospital Ethics Committee |
Approved |
| Shakti Hospital Institutional Ethics committee |
Approved |
| Shakti Hospital Institutional Ethics committee |
Approved |
| Shakti Hospital Institutional Ethics committee |
Approved |
| Shakti Hospital Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fiona is intended for contraception. It can also be used in idiopathic
menorrhagia and protection from endometrial hyperplasia during
estrogen replacement therapy. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fiona Levonorgestrel Releasing Intrauterine System |
FionaTM is an implantable Hormone Releasing Intrauterine Device |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects willing to participate in the study by signing informed consent form.
2. Healthy females between the ages of 19 and 40 years at the time of enrolment.
3. Regularly sexually active and in mutually monogamous relationship for atleast 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 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.
10.History of repeated threatened abortion, retention of placenta, or severepostpartum hemorrhage.
11.Abnormal PAP smear test.
12.History or suspicion of malignancy of genital tract 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 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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of failure of contraception as indicated by events of pregnancies inpresence of study device or due to auto-expulsion of study device
A. Number of Intra-uterine pregnancies
B. Number of ectopic pregnancies
|
Time Frame: 1 month ± 10 days, 6 months ± 30 days, 1 year ± 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
B. Number of ectopic pregnancies
2. Adverse events
A. Vulvovaginal mycotic infection
B. Vaginal bacterial infection
C. Acne
D. Breast tenderness or pain
E. Abdominal discomfort or pain
F. Dyspareunia
G. Pelvic discomfort or pain
H. Dysmenorrhea
I. Weight increase
J. Vaginal discharge
3.Blood loss
4.Tolerance
5.Safety
6.PK Endpoints
|
Time Frame: 1 month ± 10 days, 6 months ± 30 days, 1 year ± 30 days, 2 years ± 30 days, 3 years ± 30 days, 4 years ± 30 days and 5 years ± 30 days |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
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.
|