| CTRI Number |
CTRI/2024/11/077211 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Clinicopathological study of women with endometrial hyperplasia. |
|
Scientific Title of Study
|
clinicopathological study of women with endometrial hyperplasia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
priya mehar |
| Designation |
post graduate |
| Affiliation |
maulana azad medical college |
| Address |
maulana azad medical college bahadur shah zafar marg ,
New Delhi
DELHI
110002
India |
| Phone |
7838022437 |
| Fax |
|
| Email |
priya30sec2mars@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr latika sahu |
| Designation |
professor |
| Affiliation |
maulana azad medical college |
| Address |
maulana azad medical college , bahadur shah zafar marg,
New Delhi
DELHI
110002
India |
| Phone |
9654962666 |
| Fax |
|
| Email |
latikasahu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr latika sahu |
| Designation |
professor |
| Affiliation |
maulana azad medical college |
| Address |
maulana azad medical college , bahadur shah zafar marg,
New Delhi
DELHI
110002
India |
| Phone |
9654962666 |
| Fax |
|
| Email |
latikasahu@gmail.com |
|
|
Source of Monetary or Material Support
|
| maulana azad medical college |
|
|
Primary Sponsor
|
| Name |
maulana azad medical college |
| Address |
bahadur shah zafar marg , new delhi, pin code 110002 |
| 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 priya mehar |
maulana azad medical college |
bahadur shah zafar marg
Central
DELHI |
7838022437
priya30sec2mars@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| maulana azad medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N925||Other specified irregular menstruation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
medroxyprogesterone |
oral medroxyprogesterone is a pre approved drug for treatment of endometrial hyperplasia |
| Intervention |
mirena |
mirena is intra uterine device used for treatment of endometrial hyperplasia with no side effect |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
all patients visiting the OPD between 35-65 years |
|
| ExclusionCriteria |
| Details |
women below 35 years and above 65 years
no males |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| treatment outcome of women with endometrial hyperplasia after 6 months |
at 6 weeks and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| association of risk factors to endometrial hyperplasia type |
percentage wise type of disease associated with known risk factors |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
patients visiting LNH OPD with already diagnosed histopathology of endometrial hyperplasia between age group of 35-65 years will be enrolled into the study. they will be given treatment according to the latest RCOG /ACOG guidelines and followed up at 6 weeks and 6 months with symtpoms and histopatholgy as per follow up guidelines. various risk factors that are already established with the risk for endometrial hyperplasia will be studied and association between the type of disease and risk factors will be evaluated. |