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

NCT ID: NCT06316180

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometrial Polyp Endometrial Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Patients with endometrial polyps undergone hysteroscopic polipectomy without endometrial preparation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type ACTIVE_COMPARATOR

drospirenone/estetrol 3mg/14.2mg

Intervention Type DRUG

Hysteroscopic polipectomy after starting 14-day treatment with oral drospirenone/estetrol 3mg/14.2mg at any time of the menstrual cycle.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

drospirenone/estetrol 3mg/14.2mg

Hysteroscopic polipectomy after starting 14-day treatment with oral drospirenone/estetrol 3mg/14.2mg at any time of the menstrual cycle.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with endometrial polyps.

Exclusion Criteria

* Patients with other endometrial pathologies.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Roma La Sapienza

OTHER

Sponsor Role collaborator

University of Palermo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andrea Etrusco

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Andrea Etrusco

Palermo, , Italy

Site Status

Marco Monti

Rome, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DROVPREP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Surgery and ART For Endometrioma
NCT03717870 NOT_YET_RECRUITING NA