The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation

Phase 4

Completed

• Conditions: Endometrial Polyp; Endometrial Diseases
• Interventions: Drug: Ethinylestradiol / Dienogest; Drug: Nomegestrol Acetate / Estradiol; Drug: Drospirenone / Estetrol

• Registration Number: NCT06324851
• 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 or Nomegestrol Acetate/Estradiol or Ethinylestradiol/Dienogest, 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: 2024-03-15
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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
Ethinylestradiol/Dienogest	Ethinylestradiol / Dienogest	Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest at any time of the menstrual cycle
Nomegestrol Acetate/Estradiol	Nomegestrol Acetate / Estradiol	Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Nomegestrol Acetate/Estradiol at any time of the menstrual cycle
Drospirenone/Estetrol	Drospirenone / Estetrol	Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Drospirenone/Estetrol at any time of the menstrual cycle

Primary Outcome Measures

Name	Time	Method
Quality of endometrial preparation	14th day of treatment	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