| CTRI Number |
CTRI/2025/01/079068 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the Effectiveness of Low-Dose Mifepristone for Managing Uterine Fibroids in Women in Goa, India
|
|
Scientific Title of Study
|
Low-Dose Mifepristone in Fibroid Management: A Single-Center Prospective Study in Goa, India
|
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rini Naik |
| Designation |
Consultant Gynaecologist and Obstetrician |
| Affiliation |
Healthway Hospitals Pvt. Ltd., |
| Address |
Healthway Hospitals Pvt.Ltd.,
Old Goa
North Goa
GOA
403402
India |
| Phone |
9923645243 |
| Fax |
|
| Email |
rininaik123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rini Naik |
| Designation |
Consultant Gynaecologist and Obstetrician |
| Affiliation |
Healthway Hospitals Pvt. Ltd., |
| Address |
Healthway Hospitals Pvt.Ltd.,
Old Goa
North Goa
GOA
403402
India |
| Phone |
9923645243 |
| Fax |
|
| Email |
rininaik123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rini Naik |
| Designation |
Consultant Gynaecologist and Obstetrician |
| Affiliation |
Healthway Hospitals Pvt. Ltd., |
| Address |
Healthway Hospitals Pvt.Ltd.,
Old Goa
North Goa
GOA
403402
India |
| Phone |
9923645243 |
| Fax |
|
| Email |
rininaik123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Healthway Hospitals Pvt. Ltd., Plot No 132/1 (Part), Ella Village, Kadamba Plateau, Tiswadi Taluka Goa, India
403402 |
|
|
Primary Sponsor
|
| Name |
Healthway Hospitals Pvt Ltd |
| Address |
Healthway Hospitals Pvt.Ltd.,
Old Goa, 403402
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Rini Naik |
Healthway Hospitals Pvt. Ltd. |
OPD 21, Department of Obstetrics and Gynaecology, Healthway Hospitals Pvt. Ltd., Plot No 132/1 (Part), Ella Village, Kadamba Plateau, Old Goa, Goa 403402
North Goa
GOA |
9923645243
rininaik123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,HEALTHWAY HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mifepristone drug |
NAME OF MEDICATION-Mifepristone
DOSAGE-Tablet
ROUTE-Oral
DOSE-25mg
FREQUENCY-Once a day for 3 months
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Females of reproductive age group 18 to 49 years with symptomatic fibroids sized more than 3cm and less than 8cm
Women with Pictorial Blood Loss Assessment Chart PBAC more than 100
Women diagnosed with uterine fibroid |
|
| ExclusionCriteria |
| Details |
Women allergic to mifepristone
Pregnant or lactating mothers
Women with a history of DVT/thromboembolism, liver dysfunction
Those not consenting to be a part of the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
symptom relief
menstrual changes PBAC |
symptom relief 2 years
menstrual changes PBAC 2 years |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study aims to evaluate the efficacy and safety of low-dose mifepristone in managing symptomatic uterine fibroids in women of reproductive age. Uterine fibroids, common benign tumors, can cause significant symptoms like heavy bleeding, pain, and reproductive issues, traditionally managed through surgery or pharmacological treatments. Mifepristone, a progesterone receptor modulator, has shown promise in reducing fibroid size and alleviating symptoms with fewer side effects than traditional treatments. The study, conducted at Healthway Hospitals in Goa, India, will focus on women aged 18–49 with fibroids sized between 3-8 cm, assessing changes in fibroid size, symptom relief, and adverse effects. Results from similar studies suggest mifepristone can significantly reduce fibroid size, improve hemoglobin levels, and relieve menstrual bleeding and pain with minimal side effects, offering a potential non-surgical treatment option for symptomatic fibroids. The study will employ a prospective, observational design over two years, with data analyzed for descriptive statistics.
|