The Use of Drospirenone/Estetrol in Random Start Rapid Endometrial Preparation

Phase 4

Completed

• Conditions: Endometrial Polyp; Endometrial Diseases
• Interventions: Drug: drospirenone/estetrol 3mg/14.2mg

• Registration Number: NCT06316180
• Lead Sponsor: University of Palermo

Brief Summary

The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of drospirenone/estetrol, in rapid preparation of endometrium for hysteroscopic polypectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-08-01
• Study Completion: 2024-03-01
• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Patients with endometrial polyps.

Exclusion Criteria

• Patients with other endometrial pathologies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	drospirenone/estetrol 3mg/14.2mg	Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral drospirenone/estetrol 3mg/14.2mg at any time of the menstrual cycle.

Primary Outcome Measures

Name	Time	Method
Quality of endometrial preparation	Intraoperatively	Quality of endometrial preparation assessed visually intraoperatively by the surgeon using a visual analog scale from 0 to 5.

Trial Locations

Locations (2)

Andrea Etrusco; 🇮🇹 Palermo, Italy

Marco Monti; 🇮🇹 Rome, Italy