| CTRI Number |
CTRI/2023/11/060189 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
22/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of drug Ormeloxifene in preventing unscheduled bleeding after LNG coil insertion done for heavy periods . |
|
Scientific Title of Study
|
A Randomised controlled trial to evaluate the effect of ormeloxifene on unscheduled vaginal bleeding in women using levonorgestrel releasing intrauterine system |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushma |
| Designation |
Junior Resident ( Obstetrics and Gynaecolgy ) |
| Affiliation |
AIIMS , New Delhi |
| Address |
Gynae office , Third Floor ,
AIIMS , Ansari nagar
New Delhi
DELHI
110608
India |
| Phone |
7827117764 |
| Fax |
|
| Email |
sushmaprasadchaurasiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa Vatsa |
| Designation |
Assistant Professor ( Department of Obstetrics and Gynaecolgy ) |
| Affiliation |
AIIMS , New Delhi |
| Address |
Gynae office , Third Floor ,
AIIMS , Ansari nagar
Room no 5 , Department of Obstetrics and Gynaecology (OPD), MCH BLOCK ,AIIMS , Ansari nagar , New Delhi - 110029
New Delhi
DELHI
110608
India |
| Phone |
9810248161 |
| Fax |
|
| Email |
dr.richavatsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Vatsa |
| Designation |
Assistant Professor ( Department of Obstetrics and Gynaecolgy ) |
| Affiliation |
AIIMS , New Delhi |
| Address |
Gynae office , Third Floor ,
AIIMS , Ansari nagar
New Delhi
DELHI
110608
India |
| Phone |
9810248161 |
| Fax |
|
| Email |
dr.richavatsa@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sushma |
| Address |
E-41, Surya Roshni Ltd, Bahadur garh , District Jhajjar , Haryana |
| Type of Sponsor |
Other [self] |
|
|
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 Richa Vatsa |
AIIMS , Ansari nagar , New Delhi - 110029 |
MCH Block
Department of Obstetrics and Gynaecology (OPD)
Room no. 5,6,8,9,10,11
New Delhi
DELHI |
9810248161
dr.richavatsa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH ALLINDIAINTITUTEOFMEDICALSCIENCES,ANSARINAGAR,NEWDELHI110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N921||Excessive and frequent menstruation with irregular cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Only LNG-IUS insertion
|
In control group only LNG-IUS insertion will be done . |
| Intervention |
Ormeloxifene 60 mg twice a week for 3 months in test group . |
1.LNG-IUS insertion along with tab ormeloxifene 60 mg twice a week for 3 months will be started from date of insertion in test group
2.In control group LNG-IUS insertion will be done |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patient with abnormal uterine bleeding
1. Age group: 21 – 50 yrs
2. Endometrial biopsy showing benign
pathology
3. No distortion of endometrial cavity on USG
4. Uterine size < 12 week
5. Willing to provide informed written
consent.
|
|
| ExclusionCriteria |
| Details |
1. Endometrial hyperplasia with atypia /
Endometrial cancer
2. History of any malignancy
3. Current signs of PID
4. Endocrinopathy or other systemic disorder
causing heavy menstrual bleeding
5. Current signs of PID
6. Abnormal Pap smear finding
7. Pregnancy, decision of pregnancy
8. Postmenopausal
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Number of days with bleeding and spotting |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Side effects of LNG-IUS insertion
2. PBAC score in both the groups
3. Rate of discontinuation of LNG-IUS due
to side effects
4. Satisfaction level of patients
5. Side effects of ormeloxifen (ovarian
cyst, cervical erosion & discharge,
gastric dyspepsia, vague abdominal
pain, headache & others).
6. Haemoglobin level
|
1 YR |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/12/2023 |
| 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="7"
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
|
Patient presented to Gynaecology OPD with complaint of abnormal uterine bleeding and suitable for LNG-IUS insertion will be recruited . After workup of heavy menstrual bleeding , if patient is found suitable for LNG-IUS insertion , randomisation will be done in two groups by computer generated randomisation table , in block of 4 and 6 . LNG-IUS insertion along with tab ormeloxifene 60 mg twice a week for 3 months will be started from date of insertion in test group . In control group LNG-IUS insertion will be done . Follow up for AUB symptoms , side effects , PS examination and USG scan for LNG-IUS position will be done monthly for 3 months and follow up for |