| CTRI Number |
CTRI/2025/08/092186 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Letrozole and Mifepristone for early pregnancy induced abortions |
|
Scientific Title of Study
|
Comparing Letrozole and Mifepristone pretreatment for medical management of first trimester miscarriages. |
| 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 SHAZIA KHAN |
| Designation |
PROFESSOR |
| Affiliation |
INSTITUTE OF NAVAL MEDICINE |
| Address |
DEPT OF OBG INHS ASVINI RC CHURCH ROAD COLABA MUMBAI
Mumbai
MAHARASHTRA
400005
India |
| Phone |
9049484689 |
| Fax |
|
| Email |
drshaziakhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAZIA KHAN |
| Designation |
PROFESSOR |
| Affiliation |
INSTITUTE OF NAVAL MEDICINE |
| Address |
DEPT OF OBG INHS ASVINI RC CHURCH ROAD COLABA MUMBAI
Mumbai
MAHARASHTRA
400005
India |
| Phone |
9049484689 |
| Fax |
|
| Email |
drshaziakhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHAZIA KHAN |
| Designation |
PROFESSOR |
| Affiliation |
INSTITUTE OF NAVAL MEDICINE |
| Address |
DEPT OF OBG INHS ASVINI RC CHURCH ROAD COLABA MUMBAI
Mumbai
MAHARASHTRA
400005
India |
| Phone |
9049484689 |
| Fax |
|
| Email |
drshaziakhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| ANVESHAN PROJECT
COMMANDING OFFICER INHS ASVINI RC CHURCH ROAD COLABA MUMBAI 400005 MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
INHS ASVINI |
| Address |
RC CHURCH ROAD COLABA MUMBAI 400005 |
| 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 |
| SHAZIA KHAN |
INHS ASVINI |
DEPT OF OBS AND GYN INHS ASVINI RC CHURCH ROAD COLABA MUMBAI
Mumbai
MAHARASHTRA |
9049484689
drshaziakhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INHS ASVINI ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O048||(Induced) termination of pregnancywith other and unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
letrozole |
T. Letrozole 10 mg OD for 3 days , followed by 800 mcg of misoprost pv after 72 hours. |
| Comparator Agent |
T.MIFEPRISTONE 200 MG |
T.Mifepristone 200 mg single dose followed by T.Misoprost 800 mcg after 72hrs |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Women more than 21 years of age with
2. Unwanted singleton pregnancies of upto 10 wks. |
|
| ExclusionCriteria |
| Details |
The exclusion criteria includes history or evidence of adrenal pathology, steroid-dependent cancer, porphyria, poorly controlled hypertension, bronchial asthma, thromboembolism and severe cardiac/renal/liver disease, Haemoglobin level less than 9.5 g/L, presence of an intrauterine contraceptive device, breastfeeding and reported allergic reaction to mifepristone, misoprostol or letrozole |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is achievement of complete abortion |
Time taken to achieve complete abortion 1week or 2 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes include time-to-abortion interval, the number of misoprostol doses required, healthcare resource utilisation and side effects. |
2 yrs |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/08/2025 |
| 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 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
|
This will be a randomized control interventional trial. The investigators hypothesise that letrozole is equivalent to mifepristone for the pre-treatment of mTOP and propose to conduct a randomised, non-inferiority trial for mTOP up to 10 weeks gestation with two arms as detailed below: (i) Oral letrozole 10mg daily for 3 days, followed by vaginal misoprostol on Day 3 (Intervention group) (ii) Oral mifepristone 200mg once on Day 1, followed by vaginal misoprostol 800mcg on Day 3. (current practise) The investigators aim to include 150 patients with 75 in each arm, to detect a non inferiority margin of 15% with a power of 80% with 5% significance. The primary outcome is complete abortion rates(by day 7-10). Secondary outcomes include time-to-abortion interval, the number of misoprostol doses required, healthcare resource utilisation and side effects. Letrozole priming before mTOP has been proposed as an alternative to the use of mifepristone. The proposed mechanism is a reduction in serum estrogen levels, leading to a concomitant reduction in progesterone receptor concentration necessary for the maintenance of pregnancy. Several randomised controlled trials (RCTs) have been performed by comparing the effectiveness of using letrozole for mTOP priming before misoprostol versus misoprostol alone. The combination of letrozole with misoprostol has shown to be effective in improving the success rates of complete abortion up to 10 weeks gestation, compared with misoprostol alone. Given its low price, ready availability worldwide and common usage in the fields of ovulation induction and breast cancer, letrozole may be a potential alternative to mifepristone in mTOP priming. While medication costs vary from country to country, the cost of a course of letrozole is largely cheaper than mifepristone. To address the aforementioned knowledge gaps, this study aims to conduct a non-inferior RCT to investigate whether pre-treatment with letrozole before misoprostol is comparable to mifepristone pre-treatment before misoprostol mTOP in patients up to 10 weeks gestation. |