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Completed

NCT Number: NCT07636317

Letrozole Plus Misoprostol Versus Misoprostol Only in Induction of Missed Abortion

This study aimed to evaluate the effect of letrozole plus misoprostol to terminate non-viable pregnancies in first trimester compared with the use of misoprostol alone.

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Key information

Conditions

Letrozole Abortion, Missed Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Induction Misoprostol Missed Abortion Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University

Sohag, 82511, Egypt

About this study

Inducing abortion by drugs is an alternative for surgery intervention, which has economic benefits with lower side effects and its rate of success is 60 to 95%.

Letrozole is also one of aromatase inhibitors, which is used to stimulate ovulation in infertile women suffering ovulatory dysfunction. This drug is one of the main drugs for inhibiting aromatase, with a relatively short 45-hour half life, which is active orally and inhibits aromatase enzyme reversibly.

Misoprostol is a relatively safe drug and of its side effects it is possible to mention to gestational effects, feeling of warmth, and shivering. Severe side effects of misoprostol consumption are severe bleeding and endometritis, with less than 1% prevalence based on studies.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 18 to 45 years.
  • Women with nonviable pregnancies undergoing 1st-trimester abortion.

Exclusion criteria

  • Medical diseases like renal or liver disease.
  • Severe bleeding and shocked patients.
  • Inevitable abortion.
  • Hypersensitivity to any of the drugs.

Treatment and study plan

Letrozole + Misoprostol

Drug

Patients received 10 mg of Letrozole daily for three days, subsequently receiving 800 µg of Misoprostol every three hours via vaginal or sublingual routes.

Misoprostol

Drug

Patients received only 800 µg of Misoprostol.

Primary outcomes

  1. Incidence of bleeding

    Time frame: 7 days following the Misoprostol dose

    Incidence of bleeding was recorded.

Secondary outcomes

  1. Number of dosages of prostaglandins

    Time frame: 7 days following the Misoprostol dose

    Number of dosages of prostaglandins was recorded.

  2. Duration required for abortion

    Time frame: 7 days following the Misoprostol dose

    Duration required for abortion was recorded.

  3. Incidence of adverse effects

    Time frame: 7 days following the Misoprostol dose

    Incidence of adverse effects such as nausea, vomiting, gastric distress, headache, fever, and shivers were recorded.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Letrozole Plus Misoprostol Versus Misoprostol Only in Induction of Missed Abortion: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

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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