Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion

NCT02401425 | Completed Phase 2

• 1 other identifier: 1984
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

Conditions

Complete Miscarriage

Keywords

Letrozole; Misoprostol; First-Trimester; Pretreatment

Outcome Measures

Primary Outcomes (1)

• Incidence of complete abortion

  complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol

  1 week

Secondary Outcomes (3)

• Need for surgical evacuation of the products of conception

  1 week

• Maternal morbidity

  1 week

• Hemoglobin and hematocrit deficit

  1 week

Study Arms (2)

letrozole

ACTIVE COMPARATOR

Women will receive three tablets of letrozole(FemaraR, NOVARTIS) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.

Drug: Letrozole; Drug: Misoprostol

placebo

PLACEBO COMPARATOR

Women will receive three tablets of placebo as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.

Drug: Misoprostol; Other: Placebo

Interventions

Letrozole DRUG

Also known as: femara

letrozole

Misoprostol DRUG

Also known as: Misotac; Misotec; Cytotec

letrozole; placebo

Placebo OTHER

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal age more than 18 years old (age of legal consent).
• Gestational age less than 13 weeks.
• Hemoglobin \>10 g/dL.
• BMI between 25 kg/m2 and 35 kg/m2.
• Missed abortion.
• Living fetus with multiple congenital malformations incompatible with life.

You may not qualify if:

• Maternal age less than 18 years old.
• Gestational age more than 12 weeks.
• Hemoglobin \<10 g/dL.
• Anencephaly.
• Fibroid uterus.
• BMI less than 25kg/m2 and more than 35kg/m2.
• Coagulopathy.
• History or evidence of adrenal pathology.
• Previous attempts for induction of abortion in the current pregnancy.
• Allergy to misoprostol or letrozole.
• Medical disorder that contraindicate induction of abortion (e.g. heart failure).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

Letrozole; Misoprostol

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynaecology

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 27, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 29, 2015

Record last verified: 2015-09

Locations

EG (1)