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Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)

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ClinicalTrials.gov Identifier: NCT00123175
Recruitment Status : Withdrawn (Study has never received funding and has never been initiated)
First Posted : July 22, 2005
Last Update Posted : January 8, 2013
Center for Research on Women and Newborn Health
Information provided by (Responsible Party):
Richard S. Legro, M.D., 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.

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 Type : Interventional  (Clinical Trial)
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 : September 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: Intrauterine Device
    Mirena and Provera
    Other Name: Medroxyprogesterone Acetate and Progestins

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 [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Side effects [ Time Frame: 90 days ]
  2. Bleeding profile [ Time Frame: 90 days ]
  3. Estradiol and progesterone levels [ Time Frame: 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123175

Sponsors and Collaborators
Milton S. Hershey Medical Center
Center for Research on Women and Newborn Health
Principal Investigator: Richard Legro, M.D. Penn State University College of Medicine

Responsible Party: Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00123175     History of Changes
Other Study ID Numbers: 21012
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Richard S. Legro, M.D., Milton S. Hershey Medical Center:
Endometrial Hyperplasia without atypia

Additional relevant MeSH terms:
Endometrial Hyperplasia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Medroxyprogesterone Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents