Skip to main content
OpenTrials
Completed

NCT Number: NCT05198050

Letrozole in Induction of Abortion of Anembryonic Pregnancy

Some studies suggest the prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion. the aim of the study is to compare the effectiveness of various regimens of letrozole combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with blighted ovum.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anembryonic Pregnancy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

About this study

Some studies suggest prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion, increases the efficiency of the treatment regimen and also decreases the need for surgical interventions. Some conducted studies have mentioned reinforcing the impact of misoprostol with letrozole, but reaching the ideal dose still needs more studies, so in this study, the investigators will compare the effectiveness of various regimens of letrozole ( 10 mg/d for 3 days or a single dose of 20 mg) combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with a blighted ovum.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • first trimester of pregnancy
  • pregnancy duration less than 12 weeks based on LMP.
  • non-viable fetus (blighted ovum)

Exclusion criteria

  • No heart disease,
  • No asthma
  • No History of thromboembolism
  • No History of cancer
  • No renal failure
  • No liver diseases
  • History of allergy to misoprostol or letrozole drugs.

Treatment and study plan

Letrozole tablets

Drug

Letrozole is a third-generation non-steroidal aromatase inhibitor

Misoprostol Tabets

Drug

a synthetic prostaglandin medication

Other names: prostaglandin E1

Placebo tablets

Drug

Placebo tables with a similar appearance to letrozole

Primary outcomes

  1. Complete abortion

    Time frame: 2 days

    no emergency or elective curettage was necessary until next menstruation

Secondary outcomes

  1. Induction-to-abortion interval

    Time frame: 2 days

    the interval between administration of misoprostol)

  2. Adverse effects of Misoprostol

    Time frame: 2 days

    diarrhea, abdominal cramps, fever and sweating.

  3. Adverse effects of Letrozole

    Time frame: 2 days

    hot flushes, drowsiness and nausea.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Letrozole Plus Misoprostol Versus Misoprostol Alone in Induction of Abortion of Anembryonic Pregnancy:

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2022
Registry last updated
Sep 11, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.