The Use of Nomegestrol Acetate/Estradiol in Random Start Rapid Endometrial Preparation

Phase 4

Completed

• Conditions: Endometrial Polyp; Endometrial Diseases
• Interventions: Drug: Nomegestrol Acetate/Estradiol 2.5mg/1.5mg

• Registration Number: NCT06316219
• 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 Nomegestrol Acetate/Estradiol, 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	Nomegestrol Acetate/Estradiol 2.5mg/1.5mg	Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Nomegestrol Acetate/Estradiol 2.5mg/1.5mg 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)

Marco Monti; 🇮🇹 Rome, Italy

Andrea Etrusco; 🇮🇹 Palermo, Italy