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NCT06316206 Clinical Trial

The Use of Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation

Endometrial Diseases Clinical Trial

Official title:
The Use of Ethinylestradiol/Dienogest in Random Start Rapid Preparation of Endometrium Before Office Hysteroscopic Polypectomies: a Multicenter, Prospective, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06316206
Other study ID # EFFIPREP
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2023
Est. completion date March 1, 2024

Study information
Verified date April 2024
Source University of Palermo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date March 1, 2024
Est. primary completion date August 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years and older
Eligibility Inclusion Criteria: - Patients with endometrial polyps. Exclusion Criteria: - Patients with other endometrial pathologies.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ethinylestradiol/Dienogest 0.03mg/2mg
Endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral Ethinylestradiol/Dienogest 0.03mg/2mg at any time of the menstrual cycle

Locations
Country Name City State
Italy Andrea Etrusco Palermo
Italy Marco Monti Roma

Sponsors (2)
Lead Sponsor Collaborator
University of Palermo University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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