CClinicalTrials.gg
CompletedNCT05304273Updated Apr 2, 2026

Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages

A Phase 3 interventional study of Mifepristone and Letrozole in Miscarriage, sponsored by Calcutta National Medical College and Hospital. Completed at 1 site in India. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by Calcutta National Medical College and Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Miscarriage

Browse trials for

03

In context

Abortion, Spontaneous

320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.

This study's enrollment of 120 is below the median of 147 across 174 interventional studies indexed under Abortion, Spontaneous.

Browse Abortion, Spontaneous studies →

Lead sponsor

This is the only study on the registry with Calcutta National Medical College and Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

EXCLUSION CRITERIA :

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Mifepristone

    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).

    Drug: Mifepristone

  • Experimental
    Letrozole

    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).

    Drug: Letrozole

Interventions

  • DrugMifepristone

    Participants with 1st trimester miscarriage will receive for medical termination

    Also known as: Misoprostol 800 microgram vaginally

  • DrugLetrozole

    Participants with 1st trimester miscarriage will receive for medical termination

    Also known as: Misoprostol 800 microgram vaginally

06

What researchers measure

Primary outcomes

  1. Expulsion of product of conception

    Mean duration of expulsion since administration of vaginal misoprostol

    Time frame: 24 hours since administration of misoprostol

  2. Requirement of surgical evacuation

    Surgical evacuation where complete abortion does not occur

    Time frame: beyond 24 hours since misoprostol administration

07

Study locations

1 site
  • Calcutta National Medical College and Hospital
    Kolkata, West Bengal 700014, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05304273
Lead sponsor
Calcutta National Medical College and Hospital
Responsible party
Dr.Jhuma Biswas (Associate Professor, Dept. of Obstetrics and Gynecology, Calcutta National Medical College and Hospital, Calcutta National Medical College and Hospital) — Principal investigator
First posted
Mar 31, 2022
Start date
May 5, 2022
Primary completion
Jul 26, 2024
Completion
Oct 1, 2024
Last update
Apr 2, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion