The Use of Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation

NCT ID: NCT06316206

Last Updated: 2024-04-22

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

80 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 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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Control

Patients with endometrial polyps undergone hysteroscopic polipectomy without endometrial preparation.

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment

Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest 0.03mg/2mg at any time of the menstrual cycle

Group Type EXPERIMENTAL

Ethinylestradiol/Dienogest 0.03mg/2mg

Intervention Type DRUG

Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest 0.03mg/2mg at any time of the menstrual cycle

Interventions

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Ethinylestradiol/Dienogest 0.03mg/2mg

Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest 0.03mg/2mg 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.
Minimum Eligible Age

45 Years

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

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Andrea Etrusco

Palermo, , Italy

Site Status

Marco Monti

Roma, , Italy

Site Status

Countries

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Italy

References

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Etrusco A, D'Amato A, Agrifoglio V, Chiantera V, Russo G, D'Auge TG, Monti M, Riemma G, Lagana AS, Giannini A. Rapid and random-start endometrial preparation before outpatient hysteroscopic polypectomy in patients of perimenopausal age. Climacteric. 2024 Dec;27(6):561-567. doi: 10.1080/13697137.2024.2404574. Epub 2024 Sep 27.

Reference Type DERIVED
PMID: 39329272 (View on PubMed)

Other Identifiers

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EFFIPREP

Identifier Type: -

Identifier Source: org_study_id

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