NCT06316180

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 drospirenone/estetrol, in rapid preparation of endometrium for hysteroscopic polypectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

March 7, 2024

Last Update Submit

April 4, 2024

Conditions

Endometrial PolypEndometrial Diseases

Keywords

HysteroscopyEndometrial Preparation

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.

    Intraoperatively

Study Arms (2)

Control

NO INTERVENTION

Patients with endometrial polyps undergone hysteroscopic polipectomy without endometrial preparation.

Intervention

ACTIVE COMPARATOR

Patients with endometrial polyps underwent hysteroscopic polipectomy after starting 14-day treatment with oral drospirenone/estetrol 3mg/14.2mg at any time of the menstrual cycle.

Drug: drospirenone/estetrol 3mg/14.2mg

Interventions

drospirenone/estetrol 3mg/14.2mgDRUG

Hysteroscopic polipectomy after starting 14-day treatment with oral drospirenone/estetrol 3mg/14.2mg at any time of the menstrual cycle.

Intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (2)

Andrea Etrusco

Palermo, 90123, Italy

Location

Marco Monti

Rome, 00161, Italy

Location

MeSH Terms

Conditions

Uterine Diseases

Interventions

drospirenoneEstetrol

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

EstriolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

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 8, 2024

Record last verified: 2024-04

Locations

IT(2)