Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

NCT ID: NCT02440750

Last Updated: 2016-03-09

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-06-30

Brief Summary

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The presence of a thin endometrium has an important role in allowing the best conditions for hysteroscopic surgery. The aim of this study is to evaluate the efficacy of a 21 day administration of 2 mg of dienogest versus ulipristal acetate 5 mg, in rapid endometrial preparation to operative hysteroscopy.

Detailed Description

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Conditions

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Uterine Fibroids

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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Dienogest

Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die

Group Type EXPERIMENTAL

operative hysteroscopy

Intervention Type PROCEDURE

Performed under general or local anesthesia, antibioprophylaxis may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.

Dienogest

Intervention Type DRUG

21 days administration of dienogest 2 mg/die

Ulipristal acetate

Women selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die

Group Type EXPERIMENTAL

operative hysteroscopy

Intervention Type PROCEDURE

Performed under general or local anesthesia, antibioprophylaxis may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.

Ulipristal acetate

Intervention Type DRUG

21 days administration of ulipristal acetate 5 mg/die

Interventions

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operative hysteroscopy

Performed under general or local anesthesia, antibioprophylaxis may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.

Intervention Type PROCEDURE

Dienogest

21 days administration of dienogest 2 mg/die

Intervention Type DRUG

Ulipristal acetate

21 days administration of ulipristal acetate 5 mg/die

Intervention Type DRUG

Other Intervention Names

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Visanne Esmya

Eligibility Criteria

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Inclusion Criteria

* diagnosis at office hysteroscopy of symptomatic submucous myomas with intramural development (G1 and G2)

Exclusion Criteria

* pregnancy
* other hormonal therapy in the previous 8 weeks
* hepatic or renal impairment
* any medical condition that would increase the surgical risk
* refusal or unable to sign written consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cagliari

OTHER

Sponsor Role lead

Responsible Party

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Stefano Angioni

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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HYSTERO

Identifier Type: -

Identifier Source: org_study_id

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