| CTRI Number |
CTRI/2026/03/105751 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Letrozole as priming agent in First trimester MTP. |
|
Scientific Title of Study
|
Efficacy of Letrozole pretreatment prior to Misoprostol in first trimester Medical Termination of Pregnancy- A prospective clinical study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOUNDHARYA V |
| Designation |
Post Graduate |
| Affiliation |
GOVERNMENT RAJAJI HOSPITAL , MADURAI |
| Address |
Government Rajaji Hospital,
Department of Obstetrics and Gynaecology,
Madurai-625020
Madurai
TAMIL NADU
625020
India |
| Phone |
9842846984 |
| Fax |
|
| Email |
soundharyaveluchamy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR C C Nandhini |
| Designation |
Professor |
| Affiliation |
GOVERNMENT RAJAJI HOSPITAL , MADURAI |
| Address |
Government Rajaji Hospital,
Department Of Obstetrics and Gynaecology,
Madurai-625020
Madurai
TAMIL NADU
625020
India |
| Phone |
9443924974 |
| Fax |
|
| Email |
nubraganga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SOUNDHARYA V |
| Designation |
Post Graduate |
| Affiliation |
GOVERNMENT RAJAJI HOSPITAL , MADURAI |
| Address |
Government Rajaji Hospital,
Department of Obstetrics and Gynaecology,
Madurai-625020.
Madurai
TAMIL NADU
625020
India |
| Phone |
9842846984 |
| Fax |
|
| Email |
soundharyaveluchamy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SOUNDHARYA V |
| Address |
Government Rajaji Hospital,
Department Of Obstetrics and Gynaecology,Madurai-625020 |
| 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 |
| Soundharya V |
Government Rajaji Hospital, Madurai |
Government Rajaji Hospital,
Department of Obstetrics and Gynaecology, Madurai-625020
Madurai
TAMIL NADU |
9842846984
soundharyaveluchamy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE MADURAI MEDICAL COLLEGE & GOVERNMENT RAJAJI HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O021||Missed abortion, (2) ICD-10 Condition: O029||Abnormal product of conception, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
T.LETROZOLE + T.MISOPROSTOL |
T.LETROZOLE 10mg orally once daily from Day 1 to Day 3 followed by on Day-4- Misoprostol 800 mcg sublingually, single dose. (T.Letrozole 10mg will be given once daily for 3 days only followed by T.Misoprostol 800mcg sublingually single dose only.) |
| Comparator Agent |
T.MIFEPRISTONE + T.MISOPROSTOL |
T.Mifepristone 200mg orally, single dose only on Day -1 followed by on Day -3 T.Misoprostol 800mcg (buccal/sublingual/vaginal) single dose only.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Women age 18 yrs and above.
Confirmed intrauterine pregnancy upto 9 wks /63 days (based on Ultasound findings).
Indications for Termination as per MTP Act .
Hemoglobin levels greater than 10g/dl.
Willing to participate and provide written and informed consent.
|
|
| ExclusionCriteria |
| Details |
Hypersensitivity to Misoprostol/ Letrozole.
Multiple pregnancy.
Uterine anomalies.
Bronchial asthma.
Steroid hormone dependant cancer.
Systemic diseases.
Coagulopathies/Thromboembolism.
Suspected ectopic or Molar pregnancy.
Porphyria.
Severe or recurrent Liver disease or Pruritis of Pregnancy.
Breast feeding.
Acute illness of any nature.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare induction–abortion interval and rate of complete abortion without the need of surgical intervention between study (LETROZOLE+MISOPROSTOL) and control groups (MIFEPRISTONE+MISOPROSTOL) .
|
Baseline,Day-3,Day-4,Day-5,Day-6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess total duration of vaginal bleeding during abortion in both the groups & to make comparison between study & control groups.
To assess side effects & complications in both the groups.
To evaluate patient satisfaction & tolerability of the regimen in both the groups .(Graded as Satisfactory/Unsatisfactory)
|
Baseline,Day-3,Day-4,Day-5,Day-6 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
29/03/2026 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [soundharyaveluchamy@gmail.com].
- For how long will this data be available start date provided 30-12-2027 and end date provided 30-12-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Letrozole is a non steroidal, third generation aromatase inhibitor ,it acts by suppressing oestrogen synthesis , thereby causing endometrial thinning and increased uterine sensitivity to prostoglandins. Thus pretreatment with Letrozole before Misoprostol may create hormonal milieu more favourable for uterine evacuation. Mifepristone is commonly used with Misoprostol , but it has limitations such as high cost and limited availability in many regions. WHO recommends usage of Letrozole along with Misoprostol in 1st trimester Medical Termination of Pregnancy.Given limited data in Indian population, this study aims to evaluate the efficacy and safety of Letrozole pretreatment before Misoprostol in 1st trimester MTP. Study group - will be given T.LETROZOLE + T.MISOPROSTOL. Control group-will be given T.MIFEPRISTONE+ T.MISOPROSTOL. Study population- All patients eligible for MTP as per MTP Act (upto 9wks/63 days)
This study hypothese that, 1.Induction abortion interval is less and rate of complete abortion without need of surgical intervention is more in study group when compared with control group. 2.Total duration of vaginal bleeding is less in study group than control group.
This study aims to provide cheap and safe alternative regimen in 1st trimester MTP. |