Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)

NCT ID: NCT00123175

Last Updated: 2013-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Endometrial Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Interventions

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Intrauterine Device

Mirena and Provera

Intervention Type DEVICE

Other Intervention Names

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Medroxyprogesterone Acetate and Progestins

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Center for Research on Women and Newborn Health

UNKNOWN

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Richard S. Legro, M.D.

Professor, Obstetrics and Gynecology and Public Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Legro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Penn State University College of Medicine

Other Identifiers

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21012

Identifier Type: -

Identifier Source: org_study_id

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