| CTRI Number |
CTRI/2016/01/006535 [Registered on: 18/01/2016] Trial Registered Prospectively |
| Last Modified On: |
07/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to evaluate efficacy of a copper containing intrauterine device (Coated Copper- T) in reducing bleeding side effects. |
|
Scientific Title of Study
|
A Randomized, single blind, multi-center, parallel-arm, pilot scale study to ascertain the efficacy of coated Copper T in reducing bleeding side effects as Compared with Copper T 380 A for a maximum of 1 year |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HLL/CCT/RS/2014/2.0 Ver No: 2 Dated 7/04/2015 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anahita Rustom Chauhan |
| Designation |
Professor (Additional) and Unit Head |
| Affiliation |
Seth G. S. Medical College |
| Address |
Seth G. S. Medical College & KEM Hospital, Acharya Donde Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9820296488 |
| Fax |
|
| Email |
anahitachauhan@kem.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abi Santhosh Aprem |
| Designation |
Deputy Vice President |
| Affiliation |
HLL Lifecare Limited |
| Address |
Corporate R and D Centre,
HLL Lifecare Limited
Sreekaryam P O Akkulam
Thiruvananthapuram
KERALA
695017
India |
| Phone |
9447368939 |
| Fax |
|
| Email |
abi@lifecarehll.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Rajmohan |
| Designation |
Scientist E2 |
| Affiliation |
HLL Lifecare Limited |
| Address |
Corporate R and D Centre,
HLL Lifecare Limited
Sreekaryam P O Akkulam
Thiruvananthapuram
KERALA
695017
India |
| Phone |
9995216161 |
| Fax |
|
| Email |
grajmohan10@gmail.com |
|
|
Source of Monetary or Material Support
|
| HLL Lifecare Limited, Corporate R and D Centre, Sreekaryam P.O, Akkulam, Trivandrum, Kerala - 695017 |
|
|
Primary Sponsor
|
| Name |
HLL Lifecare Limited |
| Address |
Corporate R and D Centre
Akkulam
Sreekariyam P O
Trivandrum-695017
Trivandrum 695017
Kerala |
| Type of Sponsor |
Other [Research and Development Centre] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrDinesh Kansal |
Dr B L Kapur Memorial Hospital |
Department of Gynecology and Obstetrics,
Ground Floor, OP Room number- 1,
Dr. B L Kapur Memorial Hospital
Pusa road New Delhi 110005 India
Central
DELHI |
9810884822
drdineshkansal@gmail.com |
| Dr Ashish Navichandra Shah |
GMERS Medical College and General Hospital |
Department of OBG & Y,
1 Floor, Hospital Building, Room Number- 104
GMERS Medical College and General Hospital
Gotri, Gotri Road, Vadodara-390021 Gujarat
India
Vadodara
GUJARAT |
9327684251
drashishshah2001@yahoo.com |
| Dr Guruprasad Pednecar |
Goa Medical College |
Department of Obstetrics and Gynecology
Faculty Block, Ground Floor,
Goa Medical College and Hospital
NH17, Bambolim, Tisawadi 403202 Goa india
North Goa
GOA |
9823148523
rarush256@hotmail.com |
| Dr Kananbala Avinash Yelikar |
Govt. Medical College and Hospital, Aurangabad |
Department of Obstetrics and Gyneacology
Govt. Medical College and Hospital
Panchakki Rd.,
Aurangabad - 431001
Aurangabad
MAHARASHTRA |
982370103
drkanany@yahoo.co.in |
| DrGaurisankar Kamilya |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Department of Obstetrics and Gynaecology
2 floor, Ronald Ross Building,
Institute of Post Graduate Medical Education & Research and Seth Sukhlal Karnani Memorial Hospital
244 A J C Bose Road Kolkata 7000020 West Bengal India
Kolkata
WEST BENGAL |
9433122643
drkamilya@gmail.com |
| DrMaitri Chetan Shah |
Medical College and SSG Hospital |
Department of Obstetrics & Gynecology
Obstetrics and Gynecology Building ,Ground Floor,
SSG Hospital, Medical College
Jail road Indira Avenue Vadodara 390001 Gujarat India
Vadodara
GUJARAT |
9426370499
maitrishah.gynec@gmail.com |
| DrSasikala Tulugu |
Rajive Gandhi Institute of Medical Sciences and RIMS Government General Hospital |
Department of Gyneacology
Ground Floor, Room number 06,
Rajiv Gandhi Institute of Medical Sciences& RIMS
Government General Hospital,
Hudco Colony, Balaga,
Srikakulam 532001 Andhra Pradesh India
Srikakulam
ANDHRA PRADESH |
9573405562
rimsresearch@gmail.com |
| DrAnahita Rustom Chauhan |
Seth G.S Medical College and KEM Hospital |
Department of Obstetrics & Gynecology
1 floor, GORC office, Room Number 135,
Seth G. S. Medical College & KEM Hospital
Acharya Donde Marg, Parel Mumbai - 400012, Maharashtra, India
Mumbai
MAHARASHTRA |
9820296488
anahitachauhan@gmail.com |
| DrNazira Sadique |
Sri Ramachandra Medical Center |
Department of Obstetrics and Gyneacology
Block C, 2 floor, Room number 3
Sri Ramachandra Medical Center
No-1, Ramachandra Nagar, Porur, Chennai 600116 Tamil Nadu India
Chennai
TAMIL NADU |
9840046253
nazira_sadique@yahoo.co.in |
| Dr Vijaya Lakshmi Kodati |
Vasavi Medical & Research Centre, Vasavi Hospital |
Department of Gyneacology
Genenic Department, 4 Floor, OP Block
Vasavi Medical & Research Centre, Vasavi Hospital, #6-1-91, Lakadikapool, Hyderabad - 500004, Telangana, India
Hyderabad
ANDHRA PRADESH |
9848030379
kovila@gmail.com |
| DrLila Vyas |
Zanna Hospital (Associate hospital of SMS Medical College) |
Department of Obstetrics and Gynecology
Zanana Hospital (Assocaite Hospital of SMS Medical College) Doctor Chamber, Ground Floor,
Station Road Reserve Police Line, Sindhi Camp, Jaipur - 302016, Rajasthan, India
Jaipur
RAJASTHAN |
9829029039
drvyassms@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Adroit Ethics Committee,New Manak Healthcare Hospital Plot No. 2, Sector 8, Nerul (W), Navi Mumbai – 400 706. Maharashtra, India |
Approved |
| Institutional Ethics Committee for Human Research,Medical college and SSG hospital, Baroda |
Approved |
| Institutional Ethics Committee, Rajiv Gandhi Institute of Medical Sciences and RIMS Government General Hospital |
Approved |
| Institutional Ethics Committee, Sri Ramachandra University |
Approved |
| Institutional ethics committee,PGIMER,Chandigarh |
Approved |
| Institutional Human Ethics Committee, GMERS Medical college and General Hospital, Gotri, Vadodara,Gujarat |
Approved |
| IPGME&R Research Oversight Committee, 244, A.J.C, Bose Road, Kolkata-700020 |
Approved |
| Lifepoint Multispeciality Hospital 145/1, Mumbai-Bangalore highway, Near Hotel Sayaji,Pune, Maharashtra |
Approved |
| Office of Ethics committee, S.M.S Medical college and attached hospitals, Jaipur |
Approved |
| Sapthagiri institute of medical sciences and research centre, Institutional ethics committee, No.15, Chikkasandra, Hesaraghatta Main road, Bengaluru, Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Bleeding during use of Copper T |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coated Copper T |
Copper Containing intra Uterine Device coated with an FDA approved biodegradable polymer which will degrade in the body to original monomers lactic acid and glycolic acid.The degradation products are easily metabolized in the body and are eliminated. The safe polymer coating will modulate the bulk release of copper ions from the copper T device, reducing side effects such as excessive bleeding and pain. |
| Comparator Agent |
Copper T 380 A |
Copper containing Intra uterine device, available in the market for contraception. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Age between 21 and 35 years (inclusive),
2. In good general health
3. With proven fertility and requesting
contraception(Nulliparous women requesting
contraception can also be included)
4. Has regular menstrual cycles (length of cycle
21-35 days) (i.e., endogenous Cyclicity without
hormonal contraceptive use) |
|
| ExclusionCriteria |
| Details |
1. Known or suspected pregnancy
2. Breast feeding females
3. Patients using anti-coagulants
4. History of ectopic pregnancies
5. Any genital infection (until successfully treated)
6. Abnormal uterine bleeding of any origin including bleeding due to unknown causes
7. Abnormalities of the uterus resulting in distortion of the uterine cavity
8. Postpartum endometritis or infected abortion and MTP in the past < 3 months
9. Known or suspected uterine or cervical malignancy, including unresolved, abnormal “Pap†smear
10. Untreated acute cervicitis until infection is controlled
11. Diagnosed Wilson‟s disease
12. Known allergy to copper
13. Conditions associated with increased susceptibility to infection. Such conditions include, but are not limited to leukemia, diabetes acquired immune deficiency syndrome (AIDS), and those requiring chronic corticosteroid therapies
14. Genital actinomycosis
15. A previously inserted IUD that has not been removed
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess heavy menstrual bleeding between two groups using coated Copper T and conventional Copper T device. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain and comfort level will be assessed by the Quality of Life questionnaire. |
12 months |
| positive urine pregnancy test at any time within 12 months of the study |
12 months |
| patient reports IUD expulsion, these events are detected during the scheduled visits |
12 months |
| IUD removals are detected during the scheduled visits. IUD must be removed from the subject at the end of the study. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "176"
Final Enrollment numbers achieved (India)="176" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2016 |
| Date of Study Completion (India) |
03/05/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
“none yet†|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Summary
Bleeding is one of the most
common complications in IUD users.
Copper T Intra uterine devices (IUD) represent an important
contraceptive option for a very large number of women, about 160 million
worldwide. We have clinically evaluated the efficacy of Coated Copper T (CCT) in
reducing the bleeding side effects as compared with Ordinary Copper T 380A(OCT).
This multicentre,
randomized, single-blind, parallel-arm clinical trial was performed on 200
women in multiple sites from June 2016 to May 2018, in India. Participants were
allocated into two equal groups for receiving CCT or OCT IUDs in simple
randomized method (1:1). Data were collected by demographic questionnaires and
pictorial blood assessment chart (PBAC) and quality of life assessments after
IUD insertion. In this trial, between July 23 2016 and March 20 2017, 200
eligible participants were randomly assigned, of whom 100 patients were
enrolled in CCT group and 100 were enrolled in OCT group. The Mean score
bleeding in the first three months to 12 months after IUD insertion in IUD CCT
users was significantly (p<0·05) lower than IUD Copper T 380A group. The
number of times a participant reported either moderate or severe pain was more
in the OCT group as compared to the CCT group. No pregnancies or expulsion of
IUD was reported in either of the study groups.
CCT has shown promise in
our study in decreasing the menstrual blood loss and pain significantly when compared to the group using conventional OCT device.
|