Endometrial Preparation Before Operative Hysteroscopy in Premenopausal Women
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2016
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedMarch 9, 2016
March 1, 2016
10 months
March 18, 2015
March 8, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Change in mm from baseline after farmacological therapy
Secondary Outcomes (3)
Ovarian follicle dimensions
Change in mm from baseline after farmacological therapy
Endometrial appearance
Change from baseline after farmacological therapy
Operative time
Within 2 hours after the end of the hysteroscopy
Study Arms (2)
Dienogest
EXPERIMENTALWomen selected for operative hysteroscopy that received for 21 days dienogest 2 mg/die
Ulipristal acetate
EXPERIMENTALWomen selected for operative hysteroscopy that received for 21 days ulipristal acetate 5 mg/die
Interventions
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.
21 days administration of ulipristal acetate 5 mg/die
Eligibility Criteria
You may qualify if:
- diagnosis at office hysteroscopy of symptomatic submucous myomas with intramural development (G1 and G2)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 18, 2015
First Posted
May 12, 2015
Study Start
June 1, 2016
Primary Completion
April 1, 2017
Study Completion
June 1, 2017
Last Updated
March 9, 2016
Record last verified: 2016-03