| CTRI Number |
CTRI/2025/10/095930 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of effectiveness’s of letrozole with misoprostol versus mifepristone with Misoprostol in achieving complete abortions in first trimester among women aged 18-40 years a randomised controlled trial |
|
Scientific Title of Study
|
Comparison of effectiveness of letrozole with misoprostol versus mifepristone with misoprostol in achieving complete abortions in first trimester among women aged 18 – 40 years – A Randomized 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 |
Deeksha B |
| Designation |
Postgraduate |
| Affiliation |
Aarupadai Veedu medical college and hospital |
| Address |
Department Of Obstetrics and Gynaecology, A-Block, NO-22,
Aarupadai Veedu Medical College and Hospital,
Pondicherry-Cuddalore Main Road, Kirumampakkam, Pondicherry.
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7337697634 |
| Fax |
|
| Email |
deeksha162000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramya P |
| Designation |
Associate professor |
| Affiliation |
Aarupadai Veedu Medical College and Hospita |
| Address |
Department Of Obstetrics and Gynaecology, A-Block, NO-22,
Aarupadai Veedu Medical College and Hospital,
Pondicherry-Cuddalore Main Road, Kirumampakkam, Pondicherry.
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9791246020 |
| Fax |
|
| Email |
p.ramya.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeksha B |
| Designation |
Postgraduate |
| Affiliation |
Aarupadai Veedu Medical College and Hospita |
| Address |
Department Of Obstetrics and Gynaecology, A-Block, NO-22,
Aarupadai Veedu Medical College and Hospital,
Pondicherry-Cuddalore Main Road, Kirumampakkam, Pondicherry.
Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
7337697634 |
| Fax |
|
| Email |
deeksha162000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu medical college and hospital,Pondy Cuddalore main road ,Kirumampakkam Bahour Pondicherry 607402 |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu medical college and hospital |
| Address |
Aarupadai Veedu medical college and hospital
Address Department Of Obstetrics and Gynaecology, A-Block, NO-22,
Aarupadai Veedu Medical College and Hospital,
Pondicherry-Cuddalore Main Road, Kirumampakkam, Pondicherry. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 DeekshaB |
Aarupadai Veedu medical college and hospital |
Department of obstetrics and gynaecology,A block , no 22 , Aarupadai Veedu medical college and hospital, Pondicherry- Cuddalore main road, kirumampakkam , Pondicherry
Pondicherry
PONDICHERRY |
7337697634
deeksha162000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Missions Research Foundation INSTITUTE ETHICAL COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Antenatal women in first trimester needing medical termination of pregnancy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab Mifepristone 200 mg |
200 mg per oral stat |
| Intervention |
Tab.Letrozole 20mg |
20mg per |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Women with single live intrauterine pregnancy less than 12 weeks intended for medical abortion
2. No comorbidities
3. Not allergic to drug in usage
4. Willing for follow up |
|
| ExclusionCriteria |
| Details |
1) Antenatal women belong to First trimester (1-12 weeks of
gestation) and more than 32 weeks of gestation
2) Women with medical complications/ Hematological disorders
3) Women with Hemoglobinopathies
4) Liver disorder like jaundice, cirrhosis, or renal failure
5) Antenatal women with Hemoglobin level less than 7g% |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the addition of letrozole versus mifepristone with misoprostol in achieving complete abortion in first trimester among woman between age of 18-40 years. |
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate number of abortions requiring instrumentation follow up.
2.To evaluate additional dose of Misoprostol required for complete abortion in both regimens.
3.To evaluate the blood loss in both regimens
4. To evaluate the adverse effects in both regimens |
3 days |
• To evaluate the induction to complete abortion time interval in both regimen
• To evaluate the number of abortions requiring follow up instrumentation.
• To evaluate the additional dose of misoprostol required for complete abortion in both regimens.
• To estimate the amount of blood loss between both of the regimens by haemoglobin estimation.
• To evaluate the adverse effects in both regimens. |
72 hours |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 4 |
|
Date of First Enrollment (India)
|
24/10/2025 |
| 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="1"
Months="6"
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 investigate the effectiveness of the combination of regimen of Tablet Letrozole 20 mg per oral stat with Tablet Misoprostol 800 mcg per oral versus Tablet Mifepristone 200 mg per oral with Tablet Misoprostol 800 mcg per oral in achieving complete abortions in first trimester medical abortion among woman of age 18-40 years of age A randomized controlled trial will be employed and ANC mothers seeking first trimester medical abortions among the age group 18 to 40 years satisfying inclusion criteria will be provided with Tablet Letrozole 20 mg po stat with Tablet Misoprostol 800 mcg po or Tablet Mifepristone 200 mg with Tablet Misoprostol 800 mcg based on convenient sampling The effectiveness of the regimen will be based on the complete abortion rate in each of the regimen The overarching goal of the research is to determine which regimen has better complete abortion rates, lesser adverse effects and better patient satisfaction in terms of lesser blood loss, decreased hospital stay and lesser abdominal pain |