ClinicalTrials.gg
RecruitingNCT07160855Updated Sep 8, 2025

Letrozole Plus Misoprostol Versus Misoprostol Alone for Treating Women With Missed Miscarriage

A Phase 4 interventional study of Misoprostol (given vaginally) and Letrozole 5 mg in Miscarriage in First Trimester and Missed Miscarriage, sponsored by Nishtar Medical University. Recruiting at 1 site in Pakistan. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Nishtar Medical University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as recruiting.
  • Registered 3 months after the study started (first participant enrolled May 2025, registered Aug 2025).
  • Started May 2025; still recruiting 1 year 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

The goal of this clinical trial is to learn whether adding the medicine letrozole to Misoprostol helps women have a complete abortion more often than using Misoprostol alone for the treatment of missed miscarriage (when a pregnancy has stopped developing but has not yet passed naturally).

The main questions this study aims to answer are:

  1. Does taking letrozole for 3 days before misoprostol increase the chance of a complete abortion compared to misoprostol alone?
  2. Does the use of letrozole affect the time it takes for abortion to occur? Who can Join? i. Women up to 13 weeks of pregnancy (based on last menstrual period and confirmed by ultrasound) who have a missed miscarriage.

ii. Only those with a single pregnancy are eligible. iii. Women with a previous cesarean section or uterine scar are not included.

What Will Happen in the Study A total of 92 women will take part.

Participants will be randomly assigned to one of two groups:

Group A: Letrozole tablets once daily for 3 days, followed by one dose of vaginal misoprostol.

Group B: Placebo tablets for maximum of 3 days, followed by one dose of vaginal misoprostol.

Doctors will monitor whether the abortion is complete within 24 hours. If it is not, other medical procedures will be offered as needed.

Products of conception will be examined to confirm abortion.

02

Conditions studied

  • Miscarriage in First Trimester
  • Missed Miscarriage

Keywords

  • Abortion, missed
  • Abortion, induced
  • Letrozole
  • Misoprostol
  • first trimester
03

In context

Abortion, Incomplete

24 studies on the registry are indexed under Abortion, Incomplete; 5 are open to participants now.

This study's planned enrollment of 92 is below the median of 311 across 21 interventional studies indexed under Abortion, Incomplete.

Browse Abortion, Incomplete studies →

Lead sponsor

Nishtar Medical University is the lead sponsor of 29 studies on the registry; 9 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant women up till 13th weeks of gestation according to last menstrual period (LMP) dates, confirmed on ultrasound
  • Single intrauterine pregnancy
  • Planned for termination due to missed miscarriage

Exclusion criteria

Exclusion Criteria:

  • Previous history of cesarean section
  • Uterine scar due to previous procedure like myomectomy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
92 participants (estimated)

Study arms

  • Active comparator
    Misoprostol with placebo

    Vaginal Misoprostol will be instituted after oral placebo

    Drug: Misoprostol (given vaginally) · Drug: Placebo

  • Experimental
    Misoprostol with Letrozole

    After oral letrozole, vaginal Misoprostol will be instituted

    Drug: Misoprostol (given vaginally) · Drug: Letrozole 5 mg

Interventions

  • 800 micrograms of a single dose of vaginal misoprostol will be given

    Also known as: Cytotec, Arthrotec

  • 10 mg oral letrozole for 3 days will be given

    Also known as: femara

  • DrugPlacebo

    oral placebo for three days will be given

06

What researchers measure

Primary outcomes

  1. Complete abortion

    The expulsion of both fetus and placenta without operative intervention and no retained products of conception confirmed on ultrasound.

    Time frame: From start of study medication after randomization to within 24-hours

Other outcomes

  1. Induction-abortion interval

    The time interval (in hours) from the administration of first dose of Misoprostol up to the time when the fetus aborted.

    Time frame: From start of study medication to abortion, within 24-hours

07

Study locations

1 of 1 sites recruiting
  • Nishtar Medical University and Hospital
    Multan, Punjab Province 60000, Pakistan
    Recruiting
    • Afrayshum T Principal Investigator, MBBS · Contactafrayshumtariq@gmail.com · +92 3336239197
    • Rabia R Assistant Professor, FCPS · Contactdrraabia@yahoo.com · +92 3027336131
    • Afrayshum T Principal Investigator, MBBS · Principal investigator
08

References and documents

Publications

  • Abbasalizadeh F, Sahhaf F, Sadeghi-Shabestari P, Mirza-Aghazadeh-Attari M, Naghavi-Behzad M. Comparison Between Effect of Letrozole Plus Misoprostol and Misoprostol Alone in Terminating Non-Viable First Trimester Pregnancies: A Single Blind Randomized Trial. J Family Reprod Health. 2018 Mar;12(1):27-33. PubMed 30647756 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2025 (actual). Primary completion is estimated for Nov 2025, 5 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 29, 2025
First posted
Sep 8, 2025
StartActual
May 13, 2025
Primary completionEst.
Nov 12, 2025
CompletionEst.
Nov 12, 2025
Last update
Sep 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07160855
Lead sponsor
Nishtar Medical University
Responsible party
Afrayshum Tariq (Principal Investigator, Nishtar Medical University) — Principal investigator
First posted
Sep 8, 2025
Start date
May 13, 2025
Primary completion
Nov 12, 2025 (estimated)
Completion
Nov 12, 2025 (estimated)
Last update
Sep 8, 2025

Study contacts

Afrayshum T Principal Investigator, MBBS
Contact
afrayshumtariq@gmail.com
+92 3336239197
Rabia R Assistant Professor, FCPS
study chair · Nishtar Medical University and Hospital

Oversight

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

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Studies of the drug tested here: Letrozole

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