Levonorgestrel Intrauterine Device (IUD) to Treat Complex Atypical Hyperplasia (CAH) and Grade 1 Endometrioid Endometrial Carcinoma (G1EEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00788671
First received: November 10, 2008
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

The goal of this clinical research study is to learn the level of effectiveness of the Mirena intrauterine device (levonorgestrel IUD or LIUD) in treating hyperplasia of the lining of the uterus and/or early-stage cancer of the lining of the uterus. Researchers want to learn if the levonorgestrel IUD can help to shrink or slow the growth of the disease.


Condition Intervention Phase
Hyperplasia
Endometrial Cancer
Device: Levonorgestrel IUD
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Complete Regression of Disease [ Time Frame: Assessed at one year. ] [ Designated as safety issue: No ]
    Efficacy of the Levonorgestrel Intrauterine Device (IUD) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1 EEC) is defined as complete regression of disease. Complete regression of disease is defined as no evidence of disease as assessed at one year endometrial biopsy. Response is defined as total regression of disease on endometrial biopsy at the 1 year time point. For patients with CAH, there should be no residual hyperplasia on biopsy. For patients with G1 EEC, response will be defined as no residual endometrial carcinoma on biopsy. If there is residual disease as defined above, the subject will be classified as a non-responder.


Estimated Enrollment: 50
Study Start Date: November 2008
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levonorgestrel IUD
Intrauterine placement during surgery.
Device: Levonorgestrel IUD
Intrauterine placement during surgery
Other Names:
  • Intrauterine Devices
  • Contraceptive Devices, Intrauterine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients with a diagnosis of complex atypical hyperplasia or endometrial biopsy within three months of study enrollment OR patients with a diagnosis of grade 1 endometrioid endometrial carcinoma on endometrial biopsy within three months of study enrollment in the presence of one or more of the following: 1) desire for future fertility 2) morbid obesity (body mass index > 40) 3) multiple co-morbidities (American Society of Anesthesiology Classification (ASA) Class 3 or 4)
  2. No prior treatment for diagnoses in inclusion criteria 1.
  3. Women of any racial or ethnic group.
  4. Ability to comply with endometrial biopsies every 3 months.
  5. Willing and able to sign informed consent.
  6. Age greater than 18 years.

Exclusion Criteria:

  1. Diagnosis of grade 1 endometrioid endometrial carcinoma without the presence of one of the 3 criteria mentioned in inclusion criteria 1.
  2. Diagnosis of grade 2 endometrioid endometrial carcinoma or higher on endometrial biopsy or on dilation and curettage specimen.
  3. Evidence of extrauterine spread of disease on imaging or during surgical evaluation.
  4. Congenital or acquired uterine anomaly which distorts the uterine cavity.
  5. Acute pelvic inflammatory disease.
  6. Acute liver disease or previously diagnosed liver tumor (benign or malignant).
  7. Conditions associated with increased susceptibility to infections with microorganisms. Such conditions include, but are not limited to, AIDS, leukemia and IV drug abuse.
  8. Genital actinomycosis.
  9. Current carcinoma of the breast.
  10. Current pregnancy.
  11. Breastfeeding mothers.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788671

Contacts
Contact: Shannon Westin, MD 713-745-3358

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
Texas Women's Hospital Recruiting
Houston, Texas, United States, 77030
Lyndon B. Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Shannon Westin, MD The University of Texas MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00788671     History of Changes
Other Study ID Numbers: 2008-0094, NCI-2012-02118, 50 CA098258 - 05
Study First Received: November 10, 2008
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
CAH
Endometrioid Endometrial Carcinoma
Complex Atypical Hyperplasia
Levonorgestrel Intrauterine Device
Endometrial Biopsy
Endometrium
Hyperplasia of lining of the uterus (womb)
Questionnaires
Progesterone
Estrogen
Postmenopausal
Endometrial
Mirena
Intrauterine Device
Birth control
IUD
LIUD
G1EEC
Complex atypical hyperplasia
Grade 1 endometrial cancer
Early endometrial cancer

Additional relevant MeSH terms:
Endometrial Neoplasms
Hyperplasia
Carcinoma
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on September 16, 2014