NCT05198141

Brief Summary

The utilization of letrozole at a daily dose of 10 mg for medical treatment of ectopic pregnancy considerably has a high success rate without imposing any serious side effects compared to daily 5mg letrozole.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

January 4, 2022

Last Update Submit

January 15, 2022

Conditions

Ectopic Pregnancy

Keywords

LETREZOLEEctopic pregnancyInduced abortion

Outcome Measures

Primary Outcomes (2)

  • β-hCG level

    A quantitative human chorionic gonadotropin

    The β-hCG levels were assessed on the 1st of treatment

  • β-hCG level

    A quantitative human chorionic gonadotropin

    The β-hCG levels were assessed on the 11th day of treatment

Secondary Outcomes (10)

  • Complete blood count (CBC)

    Assessed on the 1st day of treatment

  • Alanine Amino Transferase (ALT)

    Assessed on the 1st and 11th day of treatment

  • Aspartate aminotransferase (AST)

    Assessed on the 1st and 11th day of treatment

  • Serum creatinine

    Assessed on the 1st and 11th day of treatment

  • Blood urea

    Assessed on the 1st and 11th day of treatment

  • +5 more secondary outcomes

Study Arms (3)

Control group I (GI)

ACTIVE COMPARATOR

Patients who were undergoing surgical treatment

Procedure: laparoscopic salpingectomy

low dose letrozole group II (GII)

EXPERIMENTAL

patients who were medically treated with 5 mg of letrozole

Drug: Letrozole tablets

High dose letrozole group (GIII)

EXPERIMENTAL

patients who were medically treated with 10 mg of letrozole using

Drug: Letrozole tablets

Interventions

Letrozole tabletsDRUG

GI: Patients who were undergoing laparoscopic salpingectomy GII: patients who medically treated with 5 mg d-1 of letrozole using two tablets (2.5 mg of Femara) every day for 10 d GIII patients who medically treated with 10 mg d-1 of letrozole using four tablets (2.5 mg of Femara) every day for 10 d (group III)

Also known as: Femara
High dose letrozole group (GIII)low dose letrozole group II (GII)
laparoscopic salpingectomyPROCEDURE

laparoscopic salpingectomy

Control group I (GI)

Eligibility Criteria

Age19 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed ectopic pregnancy was by
  • Absence of an intrauterine gestational sac on vaginal ultrasound Coupled with
  • β-hCG titers beyond the discrimination zone of at least 2,000 milli-International units (mIU/m).

You may not qualify if:

  • Patients had contraindications for letrozole
  • Patients with any systemic disease ( diabetes, hypertension, ....)
  • Patients with b-hCG levels \>3,000 mIU/mL
  • Patients with hemoglobin level \<10 g/dL,
  • Patients with platelets count \<150,000/mL,
  • Patients with elevated liver enzymes,
  • Patients with elevated blood urea, or serum creatinine
  • The presence of a fetal heartbeat in a gestational sac detected outside the uterine cavity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed ALI Alabiad

Zagazig, Sharqia Province, 14150, Egypt

Location

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ahmed I Heraiz, MD

    Zagazig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 20, 2022

Study Start

December 15, 2020

Primary Completion

November 20, 2021

Study Completion

January 1, 2022

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Table Statistical analysis Master sheet raw data (excel sheet)

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
the data will become available after one month from the approval and will be available for three months
Access Criteria
you can send a Data request email to Dr: Mohamed at drno99@yahoo.com

Available IPD Datasets

Study Protocol Access
Statistical Analysis Plan (drno99@yahoo.com)Access
Informed Consent Form Access
Individual Participant Data Set Access

Locations

EG(1)