Endometrial Preparation by Short Course of Letrozole Before Hysteroscopic Removal of Endocavitary Lesions

NCT04364581 | Unknown Phase 4

• 1 other identifier: MS.19.06.685.R1.R2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effectiveness of short course of letrozole for endometrial preparation before hysteroscopic surgery for intracavitary lesions.

Conditions

Myoma;Uterus

Keywords

Letrozole; Submucous myoma

Outcome Measures

Primary Outcomes (1)

• Operative time

  Time from start to end of the procedure

  Until 2 hours from the start of operation

Study Arms (2)

Letrozole group

ACTIVE COMPARATOR

Women will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention

Drug: Letrozole

Placebo group

PLACEBO COMPARATOR

Women will be treated with placebo for 10 days before hysteroscopic intervention

Drug: Placebo

Interventions

Letrozole DRUG

Women will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention

Also known as: Femara

Letrozole group

Placebo DRUG

Women will be treated with placebo for 10 days before hysteroscopic intervention

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with endouterine pathologies, identified by office diagnostic hysteroscopy during the early endometrial proliferative phase (cycle days 7 to 8)

You may not qualify if:

• Presence of large submucous (type I, type II) or endocavitary (type 0) fibroids (according to the European Society of Hysteroscopy Classification of Submucous Fibroids) with a diameter exceeding 4 cm, for which preoperative treatment with GnRH agonists is indicated.
• Hormonal therapies in the previous 8 weeks (including the drug of the study).
• Uterine and/or concomitant adnexal pathologies (including malignancy) for which hysteroscopic surgery was not considered either safe or the method to resolve the problem.
• Cardiovascular, hepatic, or renal impairment.
• Allergy to letrozole.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

MeSH Terms

Conditions

Myofibroma

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yomna Ayman

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Mohamed S Abdelhafez, MD

  Mansoura University

  STUDY DIRECTOR

• Rafik I Barakat, MD

  Mansoura University

  STUDY DIRECTOR

• Tarek A Shokir, MD

  Mansoura University

  STUDY CHAIR

Central Study Contacts

Mohamed S Abdelhafez, MD

CONTACT

+201144523366; msabdelhafez@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

EG (1)