Letrozole in Induction of Abortion of Anembryonic Pregnancy

NCT05198050 | Completed

• 1 other identifier: Letrozole and abortion
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anembryonic Pregnancy

Keywords

Letrozole; misoprostol; induction of abortion

Outcome Measures

Primary Outcomes (1)

• Complete abortion

  no emergency or elective curettage was necessary until next menstruation

  2 days

Secondary Outcomes (3)

• Induction-to-abortion interval

  2 days

• Adverse effects of Misoprostol

  2 days

• Adverse effects of Letrozole

  2 days

Study Arms (3)

single dose letrozole tablets

ACTIVE COMPARATOR

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; Drug: Misoprostol Tabets; Drug: Placebo tablets

multiple dose letrozole tablets

ACTIVE COMPARATOR

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; Drug: Misoprostol Tabets

misoprostol tablets

ACTIVE COMPARATOR

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; Drug: Placebo tablets

Interventions

Letrozole tablets DRUG

Letrozole is a third-generation non-steroidal aromatase inhibitor

multiple dose letrozole tablets; single dose letrozole tablets

Misoprostol Tabets DRUG

a synthetic prostaglandin medication

Also known as: prostaglandin E1

misoprostol tablets; multiple dose letrozole tablets; single dose letrozole tablets

Placebo tablets DRUG

Placebo tables with a similar appearance to letrozole

misoprostol tablets; single dose letrozole tablets

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

Location

Related Publications (4)

• Fouda UM, Sayed AM. Extended letrozole regimen versus clomiphene citrate for superovulation in patients with unexplained infertility undergoing intrauterine insemination: a randomized controlled trial. Reprod Biol Endocrinol. 2011 Jun 21;9:84. doi: 10.1186/1477-7827-9-84.

  PMID: 21693030 BACKGROUND

• 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.

  PMID: 30647756 BACKGROUND

• Lee VCY, Ng EHY, Yeung WSB, Ho PC. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):317-323. doi: 10.1097/AOG.0b013e3182073fbf.

  PMID: 21252745 BACKGROUND

• Lee VC, Yeung TW, Tang OS, Ng EH, Yeung WS, Ho PC. Effect of letrozole on uterine artery Doppler flow indices prior to first-trimester termination of pregnancy: a randomized controlled trial. Ultrasound Obstet Gynecol. 2012 Oct;40(4):392-7. doi: 10.1002/uog.11115.

  PMID: 22302719 BACKGROUND

MeSH Terms

Interventions

Letrozole; Alprostadil

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Marwa M Abdalla, MD

  Kasralainy teaching hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor of Obstetrics and Gynecology

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 20, 2022
• Study Start: April 3, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)