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Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women

Sponsor
University of Cagliari (Other)
Overall Status
Unknown status
CT.gov ID
NCT02440750
Collaborator
(none)
50
Enrollment
2
Arms
12
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: operative hysteroscopy
  • Drug: Dienogest
  • Drug: Ulipristal acetate
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Apr 1, 2017
Anticipated Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dienogest

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

Procedure: 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.

Drug: Dienogest
21 days administration of dienogest 2 mg/die
Other Names:
  • Visanne

    		•
    Experimental: Ulipristal acetate

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

    Procedure: 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.

    Drug: Ulipristal acetate
    21 days administration of ulipristal acetate 5 mg/die
    Other Names:
  • Esmya

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Endometrial thickness [Change in mm from baseline after farmacological therapy]

      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

    1. Ovarian follicle dimensions [Change in mm from baseline after farmacological therapy]

      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

    2. Endometrial appearance [Change from baseline after farmacological therapy]

      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

    3. Operative time [Within 2 hours after the end of the hysteroscopy]

      It will be expressed in minutes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Cagliari

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stefano Angioni, Associate Professor, University of Cagliari
    ClinicalTrials.gov Identifier:
    NCT02440750
    Other Study ID Numbers:
    • HYSTERO
    First Posted:
    May 12, 2015
    Last Update Posted:
    Mar 9, 2016
    Last Verified:
    Mar 1, 2016
    Additional relevant MeSH terms:
    Leiomyoma
    Dienogest
    Ulipristal acetate

    Study Results

    No Results Posted as of Mar 9, 2016