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

NCT ID: NCT06324851

Last Updated: 2024-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-03-01

Brief Summary

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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

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Conditions

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Endometrial Polyp Endometrial Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Drospirenone / Estetrol

Intervention Type DRUG

Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Drospirenone/Estetrol at any time of the menstrual cycle

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

Group Type EXPERIMENTAL

Nomegestrol Acetate / Estradiol

Intervention Type DRUG

Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Nomegestrol Acetate/Estradiol at any time of the menstrual cycle

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

Group Type EXPERIMENTAL

Ethinylestradiol / Dienogest

Intervention Type DRUG

Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest at any time of the menstrual cycle

Interventions

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Drospirenone / Estetrol

Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Drospirenone/Estetrol at any time of the menstrual cycle

Intervention Type DRUG

Nomegestrol Acetate / Estradiol

Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Nomegestrol Acetate/Estradiol at any time of the menstrual cycle

Intervention Type DRUG

Ethinylestradiol / Dienogest

Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest at any time of the menstrual cycle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with endometrial polyps.

Exclusion Criteria

* Patients with other endometrial pathologies.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role collaborator

University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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Andrea Etrusco

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Andrea Etrusco

Palermo, , Italy

Site Status

Marco Monti

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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DROVZOEFFIPREP

Identifier Type: -

Identifier Source: org_study_id

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