NCT00788671

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Atypical Endometrial Hyperplasia
• Stage I Uterine Corpus Cancer AJCC v7
• Stage IA Uterine Corpus Cancer AJCC v7
• Stage IB Uterine Corpus Cancer AJCC v7
• Stage II Uterine Corpus Cancer AJCC v7

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DEVICE	Levonorgestrel-Releasing Intrauterine System	Undergo placement of a levonorgestrel-releasing intrauterine system
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2008-11-03
• Primary completion: 2016-06-10
• Completion: 2027-11-30
• First posted: 2008-11-11
• Last updated: 2025-08-15
• Results posted: 2022-04-28

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study