MiscarriagePhase 3NCT05304273
Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages
A Phase 3 study testing Mifepristone and Letrozole in people with Miscarriage, run by Calcutta National Medical College and Hospital at 1 site in India.
Trial summary
Prospective interventional study where participants with non-viable pregnancy at 1st trimester will be randomized into two arms, one group will receive conventional treatment with oral mifepristone followed by misoprostol vaginally and another group will receive letrozole for three consecutive days followed by… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Miscarriage
- What is being tested?
- Mifepristone and Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 5 May 2022to 1 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women older than 18years who will give consent regarding medical management of missed abortion
- First trimester pregnancy (gestational age less than equal to 12weeks) with missed abortion confirmed by ultrasonography
- Hemoglobin level more than 12g/dl. To improve sample size later hemoglobin level 10 gm% or more was considered and EC was informed on 5.10.2022 about this minor change in the study design.
Who cannot join
- Hemodynamically unstable patient
- Abnormalities in blood tests including complete blood count (CBC), prothrombin time(PT), internationalised normalized ratio(INR) and fibrinogen
- History or clinical evidence of any thromboembolic impairment or deep venous thrombosis
- Having intra-uterine device
- Present or previous use of corticosteroids
- History of any malignancy
- Existing cardiovascular disease contraindicating misoprostol
Trial locations and contacts
1 site in 1 country.
India1 site
Calcutta National Medical College and Hospital
Kolkata, West Bengal, 700014
About this study
Official title: COMPARATIVE STUDY OF EFFECTS BETWEEN LETROZOLE PLUS MISOPROSTOL AND MIFEPRISTONE PLUS MISOPROSTOL IN TERMINATING NON-VIABLE FIRST TRIMESTER PREGNANCIES
Prospective interventional study where participants with non-viable pregnancy at 1st trimester will be randomized into two arms, one group will receive conventional treatment with oral mifepristone followed by misoprostol vaginally and another group will receive letrozole for three consecutive days followed by misoprostol vaginally in an attempt to terminate the pregnancy medically. Mean duration of induction to expulsion of product of conception and rate of complete abortion will be compared in two groups.
- Conditions
- Miscarriage
- Being tested
- Mifepristone, Letrozole
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
Also called Misoprostol 800 microgram vaginally
Participants with 1st trimester miscarriage will receive for medical termination
LetrozoleDrug
Also called Misoprostol 800 microgram vaginally
Participants with 1st trimester miscarriage will receive for medical termination
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone | Active comparator | Participants with 1st trimester miscarriage will receive oral 200mg mifepristone .
After 48 hours of mifepristone, 800 micro gm misoprostol will be given vaginally for expulsion of product of conception (standard care). Receives: Drug: Mifepristone |
| Letrozole | Experimental | Participants with 1st trimester miscarriage will receive 10mg letrozole orally for three consecutive days.
This is to be followed by tablet misoprostol 800 micro gm vaginally for expulsion of product of conception (standard care). Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expulsion of product of conception
Mean duration of expulsion since administration of vaginal misoprostol
Measured: 24 hours since administration of misoprostol
Requirement of surgical evacuation
Surgical evacuation where complete abortion does not occur
Measured: beyond 24 hours since misoprostol administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start5 May 2022
- Primary completion26 Jul 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calcutta National Medical College and Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr.Jhuma Biswas, Calcutta National Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304273
- Sponsor's protocol ID
- G&O/CNMC-118 dt29.12.2021
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2022
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE STUDY OF EFFECTS BETWEEN LETROZOLE PLUS MISOPROSTOL AND MIFEPRISTONE PLUS MISOPROSTOL IN TERMINATING NON-VIABLE FIRST TRIMESTER PREGNANCIES
- ClinicalTrials.gov ID
- NCT05304273
- Acronym / sponsor ID
- G&O/CNMC-118 dt29.12.2021
- Conditions
- Miscarriage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Calcutta National Medical College and HospitalOther government
- Study start
- 5 May 2022 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective interventional study where participants with non-viable pregnancy at 1st trimester will be randomized into two arms, one group will receive conventional treatment with oral mifepristone followed by misoprostol vaginally and another group will receive letrozole for three consecutive days followed by misoprostol vaginally in an attempt to terminate the pregnancy medically. Mean duration of induction to expulsion of product of conception and rate of complete abortion will be compared in two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mifepristone | Active comparator | Drug: MifepristoneParticipants with 1st trimester miscarriage will receive oral 200mg mifepristone . After 48 hours of mifepristone, 800 micro gm misoprostol will be given vaginally for expulsion of product of conception (standard care). |
| Letrozole | Experimental | Drug: LetrozoleParticipants with 1st trimester miscarriage will receive 10mg letrozole orally for three consecutive days. This is to be followed by tablet misoprostol 800 micro gm vaginally for expulsion of product of conception (standard care). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women older than 18years who will give consent regarding medical management of missed abortion
- First trimester pregnancy (gestational age less than equal to 12weeks) with missed abortion confirmed by ultrasonography
- Hemoglobin level more than 12g/dl. To improve sample size later hemoglobin level 10 gm% or more was considered and EC was informed on 5.10.2022 about this minor change in the study design.
Key exclusion criteria (7 listed)
- Hemodynamically unstable patient
- Abnormalities in blood tests including complete blood count (CBC), prothrombin time(PT), internationalised normalized ratio(INR) and fibrinogen
- History or clinical evidence of any thromboembolic impairment or deep venous thrombosis
- Having intra-uterine device
- Present or previous use of corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MifepristoneAlso: Misoprostol 800 microgram vaginallyParticipants with 1st trimester miscarriage will receive for medical termination | Drug | Mifepristone |
| LetrozoleAlso: Misoprostol 800 microgram vaginallyParticipants with 1st trimester miscarriage will receive for medical termination | Drug | Letrozole |
Primary outcome
Expulsion of product of conception
Time frame: 24 hours since administration of misoprostol
Mean duration of expulsion since administration of vaginal misoprostol
Requirement of surgical evacuation
Time frame: beyond 24 hours since misoprostol administration
Surgical evacuation where complete abortion does not occur
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mifepristone and Letrozole in people with Miscarriage, run by Calcutta National Medical College and Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expulsion of product of conception (time frame: 24 hours since administration of misoprostol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.