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CompletedNCT06316206Updated Apr 22, 2024

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

A Phase 4 interventional study of Ethinylestradiol/Dienogest 0.03mg/2mg in Endometrial Polyp and Endometrial Diseases, sponsored by University of Palermo. Completed at 2 sites in Italy. Open to female participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-22.

Sponsored by University of Palermo · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2023, registered Mar 2024).
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
45 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Endometrial Polyp
  • Endometrial Diseases

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Keywords

  • Hysteroscopy
  • Endometrial preparation
03

In context

Uterine Diseases

66 studies on the registry are indexed under Uterine Diseases; 8 are open to participants now.

This study's enrollment of 80 is below the median of 98 across 52 interventional studies indexed under Uterine Diseases.

Browse Uterine Diseases studies →

Lead sponsor

University of Palermo is the lead sponsor of 142 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients with endometrial polyps.

Exclusion criteria

Exclusion Criteria:

  • Patients with other endometrial pathologies.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • No intervention
    Control

    Patients with endometrial polyps undergone hysteroscopic polipectomy without endometrial preparation.

  • Experimental
    Treatment

    Patients 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

    Drug: Ethinylestradiol/Dienogest 0.03mg/2mg

Interventions

  • DrugEthinylestradiol/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

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What researchers measure

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.

    Time frame: 14th day of treatment

07

Study locations

2 sites
  • Andrea Etrusco
    Palermo, 90123, Italy
  • Marco Monti
    Roma, 00161, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06316206
Lead sponsor
University of Palermo
Collaborators
University of Roma La Sapienza
Responsible party
Andrea Etrusco (Principal investigator, University of Palermo) — Principal investigator
First posted
Mar 18, 2024
Start date
Jan 1, 2023
Primary completion
Aug 1, 2023
Completion
Mar 1, 2024
Last update
Apr 22, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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