The Use of Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation
1 other identifier
interventional
80
1 country
2
Brief Summary
The presence of a thin endometrium plays an important role in enabling the best conditions for hysteroscopic surgery. Recently, for this purpose, many studies have evaluated the effect of preoperative administration of a variety of drugs. We explored the efficacy of random started 14-day administration of Ethinylestradiol/Dienogest, in rapid preparation of endometrium for hysteroscopic polypectomy.
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 Jan 2023
2 active sites
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
Study Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
March 7, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedApril 22, 2024
April 1, 2024
7 months
March 7, 2024
April 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of endometrial preparation
Quality of endometrial preparation assessed visually intraoperatively by the surgeon using a visual analog scale from 0 to 5.
14th day of treatment
Study Arms (2)
Control
NO INTERVENTIONPatients with endometrial polyps undergone hysteroscopic polipectomy without endometrial preparation.
Treatment
EXPERIMENTALPatients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest 0.03mg/2mg at any time of the menstrual cycle
Interventions
Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest 0.03mg/2mg at any time of the menstrual cycle
Eligibility Criteria
You may qualify if:
- Patients with endometrial polyps.
You may not qualify if:
- Patients with other endometrial pathologies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Palermolead
- University of Roma La Sapienzacollaborator
Study Sites (2)
Andrea Etrusco
Palermo, 90123, Italy
Marco Monti
Roma, 00161, Italy
Related Publications (1)
Etrusco A, D'Amato A, Agrifoglio V, Chiantera V, Russo G, D'Auge TG, Monti M, Riemma G, Lagana AS, Giannini A. Rapid and random-start endometrial preparation before outpatient hysteroscopic polypectomy in patients of perimenopausal age. Climacteric. 2024 Dec;27(6):561-567. doi: 10.1080/13697137.2024.2404574. Epub 2024 Sep 27.
PMID: 39329272DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
- Principal investigator
Study Record Dates
First Submitted
March 7, 2024
First Posted
March 18, 2024
Study Start
January 1, 2023
Primary Completion
August 1, 2023
Study Completion
March 1, 2024
Last Updated
April 22, 2024
Record last verified: 2024-04