Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)

January 7, 2013 updated by: Richard S. Legro, M.D., Milton S. Hershey Medical Center

Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia

The purpose of this research is to determine the effectiveness of the intrauterine device (IUD) called Mirena when compared to the Provera tablets used in treating this condition.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Endometrial hyperplasia without atypia is a condition usually caused by excessive stimulation of the uterine lining (endometrium) by estrogens, and may cause irregular bleeding as a presenting symptom, but rarely may progress to endometrial cancer, which makes treatment important. The only treatment approved so far is medroxyprogesterone acetate tablets (progesterone), also known as Provera.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologic diagnosis of simple or complex endometrial hyperplasia without atypia
  • Normal pap smear within one year

Exclusion Criteria:

  • Diabetes
  • Family history of endometrial cancer
  • Contraindications for the intrauterine device

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects
Time Frame: 90 days
90 days
Bleeding profile
Time Frame: 90 days
90 days
Estradiol and progesterone levels
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

Center for Research on Women and Newborn Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

September 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

July 20, 2005

First Submitted That Met QC Criteria

July 20, 2005

First Posted (Estimate)

July 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 7, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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