Letrozole in Induction of Abortion of Anembryonic Pregnancy

September 8, 2023 updated by: Marwa Mohamed Abdalla, Cairo University

Letrozole Plus Misoprostol Versus Misoprostol Alone 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12613
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: single dose letrozole tablets
starting from the first of January, patients will receive a single dose of letrozole (20 mg) two days, before starting misoprostol administration. Placebo tables with a similar appearance to letrozole will be administered the day before misoprostol administration and on the day of misoprostol administration.
Drug: Letrozole tablets
Letrozole is a third-generation non-steroidal aromatase inhibitor
Drug: Misoprostol Tabets
a synthetic prostaglandin medication
Other Names:
  • prostaglandin E1
Drug: Placebo tablets
Placebo tables with a similar appearance to letrozole
Active Comparator: multiple dose letrozole tablets
starting from the first of January, patients will receive 10 mg letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.
Drug: Letrozole tablets
Letrozole is a third-generation non-steroidal aromatase inhibitor
Drug: Misoprostol Tabets
a synthetic prostaglandin medication
Other Names:
  • prostaglandin E1
Active Comparator: misoprostol tablets
starting from the first of January, patients will receive placebo tablets with a similar appearance to letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration.
Drug: Misoprostol Tabets
a synthetic prostaglandin medication
Other Names:
  • prostaglandin E1
Drug: Placebo tablets
Placebo tables with a similar appearance to letrozole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete abortion
Time Frame: 2 days
no emergency or elective curettage was necessary until next menstruation
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction-to-abortion interval
Time Frame: 2 days
the interval between administration of misoprostol)
2 days
Adverse effects of Misoprostol
Time Frame: 2 days
diarrhea, abdominal cramps, fever and sweating.
2 days
Adverse effects of Letrozole
Time Frame: 2 days
hot flushes, drowsiness and nausea.
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Marwa M Abdalla, MD, Kasralainy teaching hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 19, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 8, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Letrozole and abortion

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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