Levonorgestrel Intrauterine Device (IUD) to Treat Complex Atypical Hyperplasia (CAH) and Grade 1 Endometrioid Endometrial Carcinoma (G1EEC)
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00788671
First received: November 10, 2008
Last updated: May 20, 2013
Last verified: May 2013
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Purpose
The goal of this clinical research study is to learn the level of effectiveness of the Mirena intrauterine device (levonorgestrel IUD) 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: At 1 year time point in study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2008 |
| Estimated Primary Completion Date: | November 2014 (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:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 (ASA Class 3 or 4)
- No prior treatment for diagnoses in inclusion criteria 1.
- Women of any racial or ethnic group.
- Ability to comply with endometrial biopsies every 3 months.
- Willing and able to sign informed consent.
- Age greater than 18 years.
Exclusion Criteria:
- Diagnosis of grade 1 endometrioid endometrial carcinoma without the presence of one of the 3 criteria mentioned in inclusion criteria 1.
- Diagnosis of grade 2 endometrioid endometrial carcinoma or higher on endometrial biopsy or on dilation and curettage specimen.
- Evidence of extrauterine spread of disease on imaging or during surgical evaluation.
- Congenital or acquired uterine anomaly which distorts the uterine cavity.
- Acute pelvic inflammatory disease.
- Acute liver disease or previously diagnosed liver tumor (benign or malignant).
- Conditions associated with increased susceptibility to infections with microorganisms. Such conditions include, but are not limited to, AIDS, leukemia and IV drug abuse.
- Genital actinomycosis.
- Current carcinoma of the breast.
- Current pregnancy.
- Breastfeeding mothers.
Contacts and Locations
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 | |
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 |
| Study First Received: | November 10, 2008 |
| Last Updated: | May 20, 2013 |
| 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:
|
Carcinoma Endometrial Neoplasms Sarcoma, Endometrial Stromal Hyperplasia Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Diseases Genital Diseases, Female |
Neoplasms, Complex and Mixed Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Pathologic Processes 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 May 23, 2013