Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)

Phase 1

Withdrawn

• Conditions: Endometrial Hyperplasia

• Registration Number: NCT00123175
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2005-07-20
• Study First Submitted QC: 2005-07-20
• Study First Posted: 2005-07-22
• Study Start: 2009-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-07
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pathologic examination of the specimens obtained by endometrial biopsy to determine the regression of endometrial hyperplasia without atypia compared to Provera	90 days

Secondary Outcome Measures

Name	Time	Method
Side effects	90 days
Bleeding profile	90 days
Estradiol and progesterone levels	90 days