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NCT Number: NCT07160855

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

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Nishtar Medical University and Hospital

Multan, Punjab Province, 60000, Pakistan

Location status: Recruiting

Location contact

Afrayshum T Principal Investigator, MBBS

CONTACT

[email protected]

+92 3336239197

Afrayshum T Principal Investigator, MBBS

PRINCIPAL_INVESTIGATOR

Rabia R Assistant Professor, FCPS

CONTACT

[email protected]

+92 3027336131

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Misoprostol (given vaginally)

Drug

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

Other names: Cytotec, Arthrotec

Letrozole 5 mg

Drug

10 mg oral letrozole for 3 days will be given

Other names: femara

Placebo

Drug

oral placebo for three days will be given

Primary outcomes

  1. Complete abortion

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

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

Other outcomes

  1. Induction-abortion interval

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Afrayshum T Principal Investigator, MBBS

CONTACT

[email protected]

+92 3336239197

Sponsors and collaborators

Lead sponsor

Nishtar Medical University

Other

Registry information

Official study title

Comparison of Letrozole With Misoprostol Versus Misoprostol Alone in the Management of Missed Miscarriages

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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