| CTRI Number |
CTRI/2025/09/094265 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Letrozole and Mifepristone as a pretreatment in first trimester medical Abortion. |
|
Scientific Title of Study
|
Comparison of letrzole Vs Mifepristone as pre-treatment in first trimester medical abortion : A Randomised controlled Trial |
| 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.Aanchal Singh |
| Designation |
MS OBS GYNAE PG RESIDENT |
| Affiliation |
HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
Room no.24 ground floor, gynae opd. Block A Hakeem Abdul Hameed Centenary Hopsital, Guru Ravidas Marg, Hamdard Nagar, New Delhi.
Hamdard Institute of Medical Sciences and Research
Address: Guru Ravidas Marg, Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI
110062
India |
| Phone |
7982637304 |
| Fax |
|
| Email |
anchalsingh.870@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Aanchal Singh |
| Designation |
Head of Department and Professor , Obs And Gynae department |
| Affiliation |
HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
Room no.21 ground floor, gynae opd. Block A Hakeem Abdul Hameed Centenary Hopsital, Guru Ravidas Marg, Hamdard Nagar, New Delhi.
Hamdard Institute of Medical Sciences and Research
Address: Guru Ravidas Marg, Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI
110062
India |
| Phone |
9810019911 |
| Fax |
|
| Email |
drarifaanwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Aanchal Singh |
| Designation |
MS OBS GYNAE PG RESIDENT |
| Affiliation |
HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH |
| Address |
Room no.24 ground floor, gynae opd. Block A Hakeem Abdul Hameed Centenary Hopsital, Guru Ravidas Marg, Hamdard Nagar, New Delhi.
Hamdard Institute of Medical Sciences and Research
Address: Guru Ravidas Marg, Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI
110062
India |
| Phone |
7982637304 |
| Fax |
|
| Email |
anchalsingh.870@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hamdard Institute of medical sciences and research |
|
|
Primary Sponsor
|
| Name |
Hamdard Institute of Medical sciences and research |
| Address |
Hamdard Institute of Medical Sciences and Research
Address: Guru Ravidas Marg, Block D, Hamdard Nagar, New Delhi, Delhi 110062 |
| Type of Sponsor |
Private 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 Aanchal Singh |
HAMDARD INSTITUTE OF MEDICAL SCIENCE AND TECHNOLOGY |
guru Ravidas Marg, Block D, Hamdard Nagar, New Delhi, Delhi 110062
East
DELHI |
7982637304
anchalsingh.870@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Letrozole |
Tab Letrozole
Dose: 10 mg od x 3 days
Route: oral
Use: Pretreatment in first trimester Medical termination of pregnancy
also used in ovulation induction and breast cancer
Side effect: Nausea , vomitting, pain in abdomen, bleeding p/v |
| Intervention |
Mifepristone |
Tab Mifepristone as Control
Dose: 200 mg stat
Route: oral
Use:Pretreatment in Medical Termination of Pregnancy
Side effects: nausea, vomitting, pain in abdomen |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Maternal age>18yrs.
2.Women wanting medical termination of pregnancy < 12 weeks.
3.Women opting for medical termination of Pregnancy.
4.Who agreed to participate in the trial voluntarily with informed consents.
|
|
| ExclusionCriteria |
| Details |
1.Age below 18yrs
2.Suspected Ectopic Pregnancy
3.H/O any co-morbidities(CKD, Adrenal insufficiency, Heart, Liver disease)/ H/O of any coagulatory dysfunction/ anticoagulant drugs.
4.Abnormal Uterine Lesions(Fibroids, congenital malformations or intrauterine adhesions).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare efficacy of Letrozole & Mifepristone as pretreatment in First Trimester Medical Abortions.
|
Comparison between the two drugs after 2 weeks of time and assessment period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To Compare the mean induction to abortion interval.
2.To Compare the no. of doses of Tab Misoprostol required.
3.To Compare the cost effectiveness of Letrozole & Mifepristone.
|
comparison between the 2 after 2 weeks of assessment period |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
15/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 academic study is based on the two drugs already in use in the market Mifepristone and Letrozole comparison between the two drugs for 1.Efficacy 2.complete evacuation rate 3.Cost effectiveness 4. no. of doses of misoprostol required
|