NCT00490087

Brief Summary

The study aims to evaluate the long-term efficacy and prognosis of hysteroscopic resection and coagulation of the base of endometrial polyps with focal atypia in fertile women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 1999

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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, 1999

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2007

Completed
Last Updated

September 2, 2011

Status Verified

June 1, 2007

Enrollment Period

8.2 years

First QC Date

June 20, 2007

Last Update Submit

September 1, 2011

Conditions

Atypical Endometrial PolypsAtypical Endometrial Hyperplasia

Keywords

Atypical endometrial polypsAtypical Endometrial HyperplasiaHysteroscopic resectionConservative treatmentFertile women

Outcome Measures

Primary Outcomes (1)

  • Efficacy and prognosis of hysteroscopic resection of atypical polyps in terms of appearance of endometrial cancer or recurrence of atypical endometrial lesions

    Five years

Secondary Outcomes (1)

  • Recurrence rate of polyp in the two groups

    Five years

Study Arms (2)

Hysteroscopic resection plus IUD

EXPERIMENTAL
Device: Levonorgestrel intrauterine device (IUD)

Hysteroscopic resection without IUD

NO INTERVENTION

Interventions

Levonorgestrel intrauterine device (IUD)DEVICE
Hysteroscopic resection plus IUD

Eligibility Criteria

Age25 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women in fertile age desiring to preserve their uterus

You may not qualify if:

  • women with adenomatous or atypical hyperplasia in the random biopsies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Child Health, IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Location

Related Publications (1)

  • Scrimin F, Wiesenfeld U, Candiotto A, Inglese S, Ronfani L, Guaschino S. Resectoscopic treatment of atypical endometrial polyps in fertile women. Am J Obstet Gynecol. 2008 Oct;199(4):365.e1-3. doi: 10.1016/j.ajog.2008.03.041.

    PMID: 18928975RESULT

MeSH Terms

Conditions

Endometrial Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Federica Scrimin, MD

    Institute of Child Health IRCCS Burlo Garofolo, Trieste, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 22, 2007

Study Start

January 1, 1999

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

September 2, 2011

Record last verified: 2007-06

Locations

IT(1)