| CTRI Number |
CTRI/2018/06/014616 [Registered on: 26/06/2018] Trial Registered Prospectively |
| Last Modified On: |
10/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Drug treatment with mifepristone for management of uterine fibroids |
|
Scientific Title of Study
|
Comparison of efficacy and safety of different dosages of mifepristone in women with symptomatic fibroids. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrReeti Mehra |
| Designation |
Associate Professor |
| Affiliation |
Government medical college and hospital |
| Address |
Department of Obstetrics and Gynaecology
Government medical college and hospital
Sector 32
Chandigarh
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121581 |
| Fax |
|
| Email |
drreetidatta@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNeelofar Shaikh |
| Designation |
Junior resident |
| Affiliation |
Government medical college and hospital |
| Address |
Department of Obstetrics and Gynaecology
Government medical college and hospital
Sector 32
Chandigarh
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7024330790 |
| Fax |
|
| Email |
neelofarshaikh18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNeelofar Shaikh |
| Designation |
Junior resident |
| Affiliation |
Government medical college and hospital |
| Address |
Department of Obstetrics and Gynaecology
Government medical college and hospital
Sector 32
Chandigarh
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7024330790 |
| Fax |
|
| Email |
neelofarshaikh18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and hospital ,sector 32,Chandigarh. |
|
|
Primary Sponsor
|
| Name |
Department of obstetrics and gynaecology |
| Address |
Department of obstetrics and Gynaecology
Government medical college and hospital Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Reeti Mehra |
Outpatient department of GMCH 32, Chandigarh. |
2nd floor, B Block, GMCH-32
Sector 32
Chandigarh
Chandigarh
CHANDIGARH |
9646121581
drreetidatta@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Women with symptomatic fibroids, (1) ICD-10 Condition: D252||Subserosal leiomyoma of uterus, (2) ICD-10 Condition: D251||Intramural leiomyoma of uterus, (3) ICD-10 Condition: D250||Submucous leiomyoma of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mifepristone |
25mg/day for 3 months, orally |
| Comparator Agent |
Mifepristone |
50 mg biweekly for 3 months, orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Symptomatic fibroid cases, measuring at least 3 cm exhibiting heavy menstrual bleeding or dysmenorrhoea or pelvic pressure 2. Those giving consent
3. Accepting the use of non-hormonal contraceptive
4. Agreeing to endometrial biopsy if needed
|
|
| ExclusionCriteria |
| Details |
1.currently planning pregnancy during study period
2.menopausal
3.currently breastfeeding
4.adnexal mass or endometriosis
5. coagulation dysfunction or bleeding tendencies
6.severe anemia <5 g% or needing blood transfusion
7.current or recent (within 3 months) use of oral / systemic corticosteroids or mifepristone
8.use within past 6 months of GnRH analogues
9.any contraindication to receive anti-progestins
10.any history or suspicion of breast cancer or other genital malignancy
11.laboratory findings that give any suspicion of blood, liver or renal dysfunction
12.those not giving consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fibroid volume |
1.Before starting mifepristone
2.at end of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Haemoglobin levels
2. Improvement in pattern of periods and symptoms caused by fibroids.
3. Any side effects would be noted to study and compare the safety.
|
1.Before starting mifepristone
2.at end of 3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "92"
Final Enrollment numbers achieved (India)="92" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/06/2018 |
| Date of Study Completion (India) |
10/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
•Uterine fibroids are the most common benign tumour reported to occur in about 70% women in their reproductive years and about 40% have symptoms severe enough to warrant therapy. •Medical treatment is predominantly used for preoperative correction of anaemia, size reduction and symptom management. •Mifepristone is a is a progesterone receptor modulator with primarily antagonistic properties. •In various studies mifepristone has shown to decrease size of fibroid and uterus, improve anemia and fibroid-related symptoms. The present study is planned with the following objectives: •Primary objective: To compare the effect of 25 mg daily dose, with 50 mg biweekly mifepristone, on fibroid volume in women with symptomatic fibroids. •Secondary objective : To compare and study the effect of both the dosages on : 1. Haemoglobin levels 2. Improvement in pattern of periods 3. Any side effects would be noted to study and compare the safety.
|