Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women
NCT ID: NCT02440750
Last Updated: 2016-03-09
Study Results
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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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2016-06-30
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dienogest
Women selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die
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.
Dienogest
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
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.
Ulipristal acetate
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.
Dienogest
21 days administration of dienogest 2 mg/die
Ulipristal acetate
21 days administration of ulipristal acetate 5 mg/die
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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University of Cagliari
OTHER
Responsible Party
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Stefano Angioni
Associate Professor
Other Identifiers
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HYSTERO
Identifier Type: -
Identifier Source: org_study_id
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