Clinical trial · Interventional
Endometrial Preparation by Short Course of Letrozole Before Hysteroscopic Removal of Endocavitary Lesions
NCT04364581CI-TRIAL-00044869unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myoma;Uterus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Letrozole | Drug | Letrozole | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Letrozole group
- description
- Women will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention
- interventionNames
- Drug: Letrozole
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- Women will be treated with placebo for 10 days before hysteroscopic intervention
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Operative time
- timeFrame
- Until 2 hours from the start of operation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.