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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04364581
Recruitment Status : Not yet recruiting
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

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.

Condition or disease Intervention/treatment Phase
Myoma;Uterus Drug: Letrozole Drug: Placebo Phase 4

Detailed Description:

In the cycle subsequent to hysteroscopic identification of an endouteine pathology, patients who fitted with the inclusion criteria will be randomly divided into two groups; letrozole group (study group) and placebo group (control group). The randomization will be a stratified randomization with permuted blocking (the block size is randomly permuted among 2, 4, and 6) within each stratum. The only stratification variable will be by type of endouterine pathology. The randomization will be balanced (using a 1:1 treatment ratio) and will be carried out by a nurse through sealed, unlabeled, opaque envelopes containing computer-generated random numbers. The study will be double-blind (the participants, caregivers and investigators will be blinded to block size and group assignment).

Women in the letrozole group will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention while women in the placebo group will be treated with placebo for 10 days before hysteroscopic intervention in the early follicular phase of a natural cycle. In both groups, monopolar hysteroscopic surgery with glycine (1.5%) as uterine distension media will be used. Precise records of the duration of each surgical procedure, from the insertion to the removal of the resectoscope will be done.

Measurements of inflow, outflow, and amount of distension liquid absorbed by the patient will be taken meticulously. Intraoperative bleeding will be defined as "light" when bleeding does not interfere with surgery, "moderate" when bleeding required the coagulation of vessels, and "severe" when hemorrhage required immediate suspension of hysteroscopy. At the end of surgery, surgeon satisfaction with endometrial preparation using Visual Analogue Scale (VAS) and quality of visualization of the uterine cavity will be compared. Postoperative complications will be defined as the appearance of any complications occurring from the termination of the surgery to discharge.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Endometrial Preparation by Short Course of Letrozole Before Hysteroscopic Removal of Endocavitary Lesions
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arm Intervention/treatment
Active Comparator: Letrozole group
Women will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention
Drug: Letrozole
Women will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention
Other Name: Femara

Placebo Comparator: Placebo group
Women will be treated with placebo for 10 days before hysteroscopic intervention
Drug: Placebo
Women will be treated with placebo for 10 days before hysteroscopic intervention




Primary Outcome Measures :
  1. Operative time [ Time Frame: Until 2 hours from the start of operation ]
    Time from start to end of the procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04364581


Contacts
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Contact: Mohamed S Abdelhafez, MD +201144523366 msabdelhafez@gmail.com

Locations
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Egypt
Mansoura University Hospital
Mansoura, Dakahlia, Egypt, 35111
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Yomna Ayman Mansoura University
Study Director: Mohamed S Abdelhafez, MD Mansoura University
Study Director: Rafik I Barakat, MD Mansoura University
Study Chair: Tarek A Shokir, MD Mansoura University
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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT04364581    
Other Study ID Numbers: MS.19.06.685.R1.R2
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mansoura University:
Letrozole
Submucous myoma
Additional relevant MeSH terms:
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Myoma
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs