| CTRI Number |
CTRI/2025/07/091947 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two drugs in medical termination of pregnancy |
|
Scientific Title of Study
|
Letrozole versus mifepristone pre-treatment with misoprostol in medical termination of pregnancy; 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 |
Dr Vinus Bansal |
| Designation |
Junior Resident |
| Affiliation |
Dr RPGMC Kangra at Tanda Himachal Pradesh |
| Address |
Department of Obstetrics and Gynaecology
Dr RPGMC Kangra at Tanda
Himachal Pradesh
Dr. Rajendra Prasad Government Medical College,
Tanda, Kangra District,
Himachal Pradesh - 176001,
India.
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
6283611796 |
| Fax |
01892-267115 |
| Email |
bansal1531@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAMTA MAHAJAN |
| Designation |
Associate Professor |
| Affiliation |
Dr RPGMC Kangra at Tanda Himachal Pradesh |
| Address |
Department of Obstetrics and Gynaecology
Dr RPGMC Kangra at Tanda
Himachal Pradesh
Dr. Rajendra Prasad Government Medical College,
Tanda, Kangra District,
Himachal Pradesh - 176001,
India.
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8219953230 |
| Fax |
01892-267115 |
| Email |
mamtamahajan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Mahajan |
| Designation |
Assistant Professor |
| Affiliation |
Dr RPGMC Kangra at Tanda Himachal Pradesh |
| Address |
Department of Obstetrics and Gynaecology
Dr RPGMC Kangra at Tanda
Himachal Pradesh
Dr. Rajendra Prasad Government Medical College,
Tanda, Kangra District,
Himachal Pradesh - 176001,
India.
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
8219953230 |
| Fax |
01892-267115 |
| Email |
mamtamahajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Rajendra Prasad Government Medical College,
Tanda, Kangra District,
Himachal Pradesh - 176001,
India. |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
VPO Tanda Kangra Himchal Pradesh 176001 |
| 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 |
| Dr Vinus Bansal |
Dr Rajendra Prasad Government Medical Kangra at Tanda Himachal Pradesh |
Opd 12 , Department of Obstetrics and Gynaecology
Kangra
HIMACHAL PRADESH
Kangra
HIMACHAL PRADESH |
6283611796
bansal1531@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee DR RPGMC |
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 |
| Comparator Agent |
LETROZOLE VERSUS MIFEPRISTONE PRE-TREATMENT WITH MISOPROSTOL IN MEDICAL TERMINATION OF PREGNANCY ;A RANDOMIZED CONTROLLED TRIAL
|
Group 2
Fifty women randomized to group 2 will receive 200 mg of Mifepristone on day 1 under supervision. On 3rd day 800mcg Misoprostol will be kept vaginally by the investigator in the hospital. Patient will be kept under observation for 6 hours .Dose of 400 microgram Misoprostol will be kept vaginally if no symptoms of abortion occur after 4 hours. |
| Intervention |
LETROZOLE VERSUS MIFEPRISTONE PRE-TREATMENT WITH MISOPROSTOL IN MEDICAL TERMINATION OF PREGNANCY ;A RANDOMIZED CONTROLLED TRIAL
The duration of the study will be 1 year |
After assessment by senior consultant all women planned for medical termination of pregnancy will be counselled for recruitment in the study .They will be randomized on the basis of computer generated random number table to receive either of the two groups.
Group 1
Fifty women will be randomized to this group. They will receive 10mg Letrozole on day 1 under supervision , 2nd and 3rd dose of 10mg Letrozole will be guided to be taken at home. On 3rd day 800mcg Misoprostol will be kept vaginally by the investigator in the hospital. Patient will be kept under observation for 6 hours . Dose of 400 microgram Misoprostol will be kept vaginally if no symptoms of abortion occur after 4 hours. Further dose of Misoprostol will be given only if required.
Group 2
Fifty women randomized to group 2 will receive 200 mg of Mifepristone on day 1 under supervision. On 3rd day 800mcg Misoprostol will be kept vaginally by the investigator in the hospital. Patient will be kept under observation for 6 hours .Dose of 400 microgram Misoprostol will be kept vaginally if no symptoms of abortion occur after 4 hours.
Duration of the study will be 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Women with age 18 to 40 years
2. Singleton pregnancy
3. Gestational age less than or equal to 9 weeks or 63 days of amenorrhea based on history, clinical examination, or ultrasonography if required
4. Patient requesting for mTOP and eligible for legal abortion according to the Termination of Pregnancy act. |
|
| ExclusionCriteria |
| Details |
1.Inevitable or incomplete abortion
2.Suspected ectopic pregnancy
3.Anemia (Hemoglobin less than 8gm %)
4.Any history suggestive of drug allergy or allergy to mifepristone ,misoprostol or
letrozole drugs
5.Presence of maternal disease such as cardiovascular disease, liver failure , respiratory distress ,asthma , adrenal insufficiency, renal failure , history of thromboembolism and on anticoagulant therapy
6. Any history of joint pain and stiffness , osteoporosis . |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare effectiveness of Letrozole versus Mifepristone pre-treatment with Misoprostol in medical termination of pregnancy of gestation equal to or less than 9 weeks |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incomplete abortion
Yes
No
|
If sonography after 2 weeks suggests retained products or causes anemia |
Complete abortion
Yes
No |
Products of conception are seen grossly, progressive decrease in the bleeding, urinary pregnancy test will become negative after 2 weeks, confirmed on sonography |
| Total no. Of misoprostol dose required |
Given 4 hourly if signs of expulsion are not evident |
Need for incomplete evacuation
Yes
No |
If sonography after 2 weeks suggests retained products or causes anemia |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/08/2025 |
| 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="1"
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
|
Induced abortions can be performed by medical and surgical methods.The standard of care for TOP has shifted from a predominantly surgical approach towards medical strategy. Medical termination of pregnancy has increased in popularity worldwide as it is non-invasive , there is avoidance of risks associated with surgery, cost effective and with a high level of patient satisfaction. Various agents have been assessed in combination with misoprostol to improve success of mTOP including mifepristone, gemeprost and tamoxifen . In general mTOP involves using either a combined regimen consisting of mifepristone and misoprostol which is the current gold standard of care, or a misoprostol-only regimen. WHO recommends the use of mifepristone for pre-misoprostol priming when mifepristone is available, and an alternative of misoprostol-only when mifepristone is not accessible. Compared with misoprostol alone, pre-treatment with mifepristone followed by misoprostol has been shown to improve the success rate of complete abortion. Worldwide access to mifepristone, despite being developed in 1980 , is limited and it is expensive .Hence there is an urgent unmet need for a cheaper and more readily available alternative. Letrozole priming before mTOP has been proposed as an alternative to the use of mifepristone by who. The successfull completion of this RCT may lead to the introduction of a more costeffective and easily accessible mTOP service for patients, as letrozole is cheaper and more widely available as compared to mifepristone . |