| CTRI Number |
CTRI/2012/07/002843 [Registered on: 31/07/2012] Trial Registered Prospectively |
| Last Modified On: |
22/08/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the efficacy and safety of Levonorgestrel Intrauterine System (Emily) in Indian women
with Dysfunctional Uterine Bleeding
|
|
Scientific Title of Study
|
An Open-label, Prospective, Multicentric, Single-arm,
Phase IV Study to Assess the Efficacy and Safety of
Levonorgestrel Intrauterine System (Emily) in Indian Women
with Dysfunctional Uterine Bleeding
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HLL/EMILY/OS/2012/1.0, version 1.1, date: 9-7-2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijayalakshmi R |
| Designation |
Gynaecologist |
| Affiliation |
Bangalore Medical Center |
| Address |
Bangalore Medical Center, 416, 4th Cross, 2nd Block,
Kalyan Nagar, Bangalore
Bangalore
KARNATAKA
560043
India |
| Phone |
09845373751 |
| Fax |
|
| Email |
dr_vijayalakshmi@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Rajasekharan Nair |
| Designation |
Professor of Obstetrics and Gynaecology |
| Affiliation |
SUT Academy of medical sciences |
| Address |
SUT Academy of medical sciences
Trivandrum
Thiruvananthapuram
KERALA
695004
India |
| Phone |
08086275103 |
| Fax |
|
| Email |
drvrsn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGRajmohan |
| Designation |
Scientist (Clinical operations) |
| Affiliation |
HLL Lifecare Limited |
| Address |
HLL Lifecare Limited
Poojapura
Trivandrum
Thiruvananthapuram
KERALA
695012
India |
| Phone |
09995216161 |
| Fax |
|
| Email |
rajmohan@lifecarehll.com |
|
|
Source of Monetary or Material Support
|
| HLL Lifecare Limited ( A Government of India Enterprise),
HLL Bhavan,
Poojappura, Thiruvananthapuram, Kerala, India |
|
|
Primary Sponsor
|
| Name |
HLL Lifecare Limited |
| Address |
HLL Bhavan
Poojappura, Trivandrum- 695 012 |
| Type of Sponsor |
Other [Government of India Enterprise] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meenakshi Sahu |
Adiva Hospital |
Gynecology & Obstetric Department, 15, Anand Lok, August Kranti Marg
Central
DELHI |
09313872444
meenakshi_sahu@rediffmail.com |
| Dr Vijayalakshmi R |
Bangalore Medical Center |
Department of Gynecology & Obstetrics, 416, 4th Cross, 2nd Block, Kalyan Nagar
Bangalore
KARNATAKA |
09845373751
dr_vijayalakshmi@hotmail.com |
| Dr Rajini Uday |
Isha Diagnostics |
Gynecology Department , 15 Cross, Malleswaram, no. 311, Sampighe road
Bangalore
KARNATAKA |
09448955892
rajini_uday@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Clinical ethics forum, Mumbai |
Approved |
| CLINICOM Independent Ethics Committee, Bangalore |
Approved |
| CLINICOM, Bangalore |
Approved |
| Global hospitals Institutuional ethics committee, Hyderabad |
Approved |
| Hippocrates Independent Ethics Committee, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dysfunctional Uterine Bleeding , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Emily |
Levonorgestrel-releasing Intrauterine System (52 mg), delivering up to 20 μg Levonorgestrel per day, to be inserted and kept in the uterus up to 180 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Indian women >30 and <50 years of age suffering from DUB
2. Married and having at least one normal living child
3. Must be having a history of excessive menstrual bleeding for a minimum of last 3 cycles (as evidenced by a baseline Pictorial Blood Assessment Chart [PBAC] score1 of 100 or more)
4. Not using any other hormonal method of contraception
5. Willing to use IUS for the treatment of DUB
6. Not contemplating pregnancy during the course of study
7. Must be willing to give written informed consent and comply with the study procedures
8. Expect to continue living in an area accessible to the study center for the duration of the study
|
|
| ExclusionCriteria |
| Details |
. Known or suspected pregnancy
2. Last delivery or abortion within the past 3 months
3. Intermenstrual bleeding
4. Postmenopausal bleeding (bleeding after more than one year from the last menstrual period)
5. Demonstrable pathological cause for DUB including pelvic inflammatory disease and
untreated acute cervicitis or vaginitis
6. Congenital abnormality of the uterus
7. Abnormal PAP smear report
8. Presence of diabetes mellitus (subjects with a random blood sugar [RBS] level above
200 mg/dL)
9. Uncontrolled hypertension defined as BP _140/90 mm Hg in a supine position after resting
for 15 minutes)
10. History or presence of incapacitating migraine
11. History of cerebrovascular disease and coronary artery disease
12. Known or suspected tumors of liver, kidney, ovary, uterus, cervix and breast
13. History of thrombophlebitis or thromboembolism in the past
14. On any prohibited medication (hepatotoxic drugs, herbal or ayurvedic products) during the
past one month
15. On immunosuppressive treatment
16. Known hypersensitivity to micronized progesterone or silicone rubber or any component of this product
17. Thyroid Stimulating Hormone (TSH) levels <0.4 IU/mL and >7 IU/mL
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
(1) To assess the efficacy of Levonorgestrel Intrauterine System (LNG-IUS) (Emily) in terms of the reduction of menstrual blood loss in Indian women with Dysfunctional Uterine Bleeding (DUB)
(2) To assess the acceptability rate of LNG-IUS (Emily)
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(3) To assess subject satisfaction from improvement in the quality of life using EQ-5D-3L Quality Of Life (QOL) Questionnaire
(4) To assess the safety of LNG-IUS (Emily)
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/08/2012 |
| 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="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dysfunctional uterine bleeding (DUB) or menorrhagia is one of the
most frequent reasons for gynecological consultation. One in 20 women (aged
30–49 years) has menorrhagia which accounts for 12% of all gynecological
referrals. Treatment options include oral contraceptives, progestin, non‑steroidal
anti‑inflammatory drugs or surgical procedures such as hysterectomy,
endometrial resection and laser ablation. Many of the drugs are associated with
unpleasant side effects and the various operative procedures are associated
with inherent risks. The Levonorgestrel (LNG) releasing intra uterine system (IUS)
has a strong antiproliferative effect on the endometrium with resultant reduction
in blood loss during menstruation. The LNG containing IUS (EMILY) is similar to
other IUS in the market which has been shown to be effective in achieving
reduction in menstrual blood loss. The present study is an open-label, prospective, multicentric, single-arm,
study to assess the efficacy and safety of Levonorgestrel Intrauterine System
(Emily) in 75 Indian women with DUB. The primary outcome measures will be to
assess the efficacy of the LNG-IUS
(Emily) in terms of the
reduction of menstrual blood loss and the overall acceptance rate. The secondary outcome measures will
be to assess subject satisfaction from improvement in the quality of life using
EQ-5D-3L QOL questionnaire and to assess the safety of the LNG-IUS (Emily).
|