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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
Bayer |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00788671 |
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 |
| 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 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shannon Westin, MD | 713-745-3358 |
| 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 | |
| Principal Investigator: | Shannon Westin, MD | The University of Texas MD Anderson Cancer Center |
More Information
| 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: | November 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
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 CAH G1EEC Complex atypical hyperplasia Grade 1 endometrial cancer Early endometrial cancer |
|
Carcinoma Endometrial Neoplasms Sarcoma, Endometrial Stromal Hyperplasia 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 |