Clinical Trials Logo
  1. Home
  2. Atypical Endometrial Hyperplasia
  3. NCT00788671

Levonorgestrel-Releasing Intrauterine System in Treating Patients With Complex Atypical Hyperplasia or Grade I Endometrial Cancer

Atypical Endometrial Hyperplasia Clinical Trial

Official title:
A Phase II Study of the Levonorgestrel Intrauterine Device (Mirena) to Treat Complex Atypical Hyperplasia and Grade 1 Endometrioid Endometrial Carcinoma

Clinical Trial Summary

This phase II trial studies how well levonorgestrel-releasing intrauterine system works in treating patients with complex atypical hyperplasia or grade I endometrial cancer. High levels of estrogen can cause the growth of endometrial cancer cells. Progesterone can help balance the amount of estrogen present. Hormone therapy using levonorgestrel, a type of progesterone, may fight endometrial cancer by helping regulate hormone levels.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the efficacy of the levonorgestrel intrauterine device (IUD) (levonorgestrel-releasing intrauterine system) to treat complex atypical hyperplasia (CAH) and grade 1 endometrioid endometrial carcinoma (G1 EEC). II. To determine if response to therapy can be predicted based on the molecular profile of the tumor or by change in gene expression after therapy. SECONDARY OBJECTIVES: I. To assess quality of life outcomes in patients treated with levonorgestrel IUD. II. To document the toxicity profile of the levonorgestrel IUD in the treatment of complex atypical hyperplasia and grade 1 endometrioid endometrial cancer. III. To evaluate the molecular profile of the hysterectomy specimen of patients treated with the levonorgestrel IUD. Compare molecular profile in pretreatment tissue to hysterectomy tissue between responders and non-responders to levonorgestrel IUD therapy. IV. To evaluate long-term survival, disease status, and fertility outcomes in patients with levonorgestrel IUD. OUTLINE: Patients undergo placement of a levonorgestrel-releasing intrauterine system. After completion of study treatment, patients are followed up every 3 months for 1 year, and then periodically for up to 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00788671
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 3, 2008
Completion date November 30, 2024
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02397083 - Levonorgestrel-Releasing Intrauterine System With or Without Everolimus in Treating Patients With Atypical Hyperplasia or Stage IA Grade 1 Endometrial Cancer Phase 2
Recruiting NCT05647109 - Patient-derived Tumor-like Cell Clusters Predict Progesterone Sensitivity in Patients With Early Endometrial Cancer
Completed NCT04491682 - Megestrol Acetate Plus Rosuvastatin in Young Women With Atypical Endometrial Hyperplasia Phase 2/Phase 3
Completed NCT04385667 - LVN- IUS Versus Oral Megesterol Acetate in Treatment of Atypical Endometrial Hyperplasia Phase 2/Phase 3
Withdrawn NCT01943058 - Megestrol Acetate or Levonorgestrel-Releasing Intrauterine System in Treating Patients With Atypical Endometrial Hyperplasia or Endometrial Cancer Phase 2
Withdrawn NCT04683237 - Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia Phase 2/Phase 3
Completed NCT00483327 - Management of Atypical Endometrial Hyperplasia and Endometrial Carcinoma Using Megestrol Acetate Phase 2
Recruiting NCT05316493 - Weight Management Plus LNG-IUS/Megestrol Acetate in Endometrial Atypical Hyperplasia Phase 2/Phase 3
Completed NCT03241888 - Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia Phase 2/Phase 3
Recruiting NCT05316935 - GnRHa + Letrozole in Non-obese Progestin-insensitive Endometrial Cancer and Atypical Hyperplasia Patients Phase 2/Phase 3
Recruiting NCT06379113 - GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients Phase 2/Phase 3
Recruiting NCT06390904 - GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Atypical Hyperplasia Patients Phase 2/Phase 3
Recruiting NCT05172999 - Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia Phase 2/Phase 3
Recruiting NCT05675787 - Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Early Endometrial Carcinoma and Atypical Endometrial Hyperplasia Phase 2
Active, not recruiting NCT03671811 - Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy Phase 2
Completed NCT00490087 - Resectoscopic Treatment of Atypical Endometrial Polyps in Fertile Women Phase 3
Terminated NCT04607252 - Metformin Plus Megestrol Acetate as a Fertility-sparing Treatment in Patients With Atypical Endometrial Hyperplasia Phase 2/Phase 3
Recruiting NCT05051722 - Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Active, not recruiting NCT00892866 - CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells N/A
Recruiting NCT03463252 - Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC Phase 2/Phase 3