Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00123175
• Collaborator: Center for Research on Women and Newborn Health (Other)
• Enrollment: 0
• Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Hyperplasia	Device: Intrauterine Device	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia
• Study Start Date: Sep 1, 2009
• Anticipated Primary Completion Date: Sep 1, 2011
• Anticipated Study Completion Date: Sep 1, 2011

Outcome Measures

Primary Outcome Measures

1. 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

1. Side effects [90 days]

2. Bleeding profile [90 days]

3. Estradiol and progesterone levels [90 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Milton S. Hershey Medical Center
• Center for Research on Women and Newborn Health

Investigators

• Principal Investigator: Richard Legro, M.D., Penn State University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT00123175
• Other Study ID Numbers: 21012
• First Posted: Jul 22, 2005
• Last Update Posted: Jan 8, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center: Endometrial Hyperplasia without atypia
• Additional relevant MeSH terms: Endometrial Hyperplasia; Hyperplasia; Medroxyprogesterone Acetate; Medroxyprogesterone; Progestins

Study Results

No Results Posted as of Jan 8, 2013