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Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

Primary Purpose

Uterine Fibroids

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
operative hysteroscopy
Dienogest
Ulipristal acetate
Sponsored by
University of Cagliari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Dienogest

    Ulipristal acetate

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Endometrial thickness
    We perform a transvaginal ultrasound (baseline) and we measure the maximum thickness of endometrial line; at the time of surgery (operative hysteroscopy) we repeat the ultrasound after pharmacological treatment. It will be expressed in mm

    Secondary Outcome Measures

    Ovarian follicle dimensions
    We perform a transvaginal ultrasound (baseline) and we measure the maximum diameter of follicles; at the time of surgery (operative hysteroscopy) we repeat the ultrasound after pharmacological treatment. It will be expressed in mm
    Endometrial appearance
    We perform a diagnostic hysteroscopy (baseline) and we describe the endometrial appearance; at the time of surgery (operative hysteroscopy) we describe the endometrial appearance after pharmacological treatment
    Operative time
    It will be expressed in minutes

    Full Information

    First Posted
    March 18, 2015
    Last Updated
    March 8, 2016
    Sponsor
    University of Cagliari
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02440750
    Brief Title
    Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    April 2017 (Anticipated)
    Study Completion Date
    June 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Cagliari

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Uterine Fibroids

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dienogest
    Arm Type
    Experimental
    Arm Description
    Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die
    Arm Title
    Ulipristal acetate
    Arm Type
    Experimental
    Arm Description
    Women selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die
    Intervention Type
    Procedure
    Intervention Name(s)
    operative hysteroscopy
    Intervention Description
    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
    Drug
    Intervention Name(s)
    Dienogest
    Other Intervention Name(s)
    Visanne
    Intervention Description
    21 days administration of dienogest 2 mg/die
    Intervention Type
    Drug
    Intervention Name(s)
    Ulipristal acetate
    Other Intervention Name(s)
    Esmya
    Intervention Description
    21 days administration of ulipristal acetate 5 mg/die
    Primary Outcome Measure Information:
    Title
    Endometrial thickness
    Description
    We perform a transvaginal ultrasound (baseline) and we measure the maximum thickness of endometrial line; at the time of surgery (operative hysteroscopy) we repeat the ultrasound after pharmacological treatment. It will be expressed in mm
    Time Frame
    Change in mm from baseline after farmacological therapy
    Secondary Outcome Measure Information:
    Title
    Ovarian follicle dimensions
    Description
    We perform a transvaginal ultrasound (baseline) and we measure the maximum diameter of follicles; at the time of surgery (operative hysteroscopy) we repeat the ultrasound after pharmacological treatment. It will be expressed in mm
    Time Frame
    Change in mm from baseline after farmacological therapy
    Title
    Endometrial appearance
    Description
    We perform a diagnostic hysteroscopy (baseline) and we describe the endometrial appearance; at the time of surgery (operative hysteroscopy) we describe the endometrial appearance after pharmacological treatment
    Time Frame
    Change from baseline after farmacological therapy
    Title
    Operative time
    Description
    It will be expressed in minutes
    Time Frame
    Within 2 hours after the end of the hysteroscopy

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

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