Treatment of Endometrial Hyperplasia With an Intrauterine Device (IUD)

This study has been withdrawn prior to enrollment.
(Study has never received funding and has never been initiated)
Center for Research on Women and Newborn Health
Information provided by (Responsible Party):
Richard S. Legro, M.D., Milton S. Hershey Medical Center Identifier:
First received: July 20, 2005
Last updated: January 7, 2013
Last verified: January 2013
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 Intervention Phase
Endometrial Hyperplasia
Device: Intrauterine Device
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia

Resource links provided by NLM:

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Bleeding profile [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Estradiol and progesterone levels [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Intrauterine Device
    Mirena and Provera
    Other Name: Medroxyprogesterone Acetate and Progestins
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.

Ages Eligible for Study:   18 Years and older
Genders 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
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Richard S. Legro, M.D., Professor, Obstetrics and Gynecology and Public Health Sciences, Milton S. Hershey Medical Center Identifier: NCT00123175     History of Changes
Other Study ID Numbers: 21012 
Study First Received: July 20, 2005
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Endometrial Hyperplasia without atypia

Additional relevant MeSH terms:
Endometrial Hyperplasia
Genital Diseases, Female
Pathologic Processes
Uterine Diseases
Medroxyprogesterone Acetate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Physiological Effects of Drugs
Reproductive Control Agents processed this record on May 26, 2016