NCT01943058

Megestrol Acetate or Levonorgestrel-Releasing Intrauterine System in Treating Patients With Atypical Endometrial Hyperplasia or Endometrial Cancer

A Phase II Head-to-Head Comparison of Fertility-Sparing Approaches to Treat Complex Atypical Hyperplasia of the Edometrium: Megestrol Versus Levonorgestrel-Releasing Intrauterine System (LNG-IUS)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well megestrol acetate or levonorgestrel-releasing intrauterine system works in treating patients with atypical endometrial hyperplasia or endometrial cancer. Progesterone can cause the growth of endometrial cancer cells. Hormone therapy using megestrol acetate or levonorgestrel-releasing intrauterine system may fight endometrial cancer by lowering the amount of progesterone the body makes. It is not yet known whether megestrol acetate is more effective than levonorgestrel-releasing intrauterine system in treating atypical endometrial hyperplasia or endometrial cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine if the levonorgestrel-releasing intrauterine system (IUS) results in histologic regression of the endometrial lesion (complex atypical hyperplasia \[CAH\] and grade 1 endometrial cancer \[EC\]) comparable to that achieved with oral megestrol (megestrol acetate). SECONDARY OBJECTIVES: I. To compare both the side effect profiles, such as weight gain and mood changes as well as compliance with assigned treatment between the 2 treatment arms. TERTIARY OBJECTIVES: I. To describe fertility-related outcomes, ovulation, menstrual pattern and fertility abnormalities determined during usual workup (e.g., semen analysis), pregnancy and delivery within 18-months of treatment. II. To characterize the incidence of endocrine comorbidities (e.g., hypothyroidism, polycystic ovarian syndrome, and diabetes). III. To characterize the association of levels of endoplasmic reticular (ER) stress and protein kinase B (Akt)-activation in endometrial samples with clinicopathologic-response to Progestin (therapeutic progesterone) therapy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive megestrol acetate orally (PO) twice daily (BID) for up to 18 months in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive levonorgestrel-releasing IUS with continuous release for up to 18 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 3 and 6 months.

Conditions

• Atypical Endometrial Hyperplasia
• Endometrial Adenocarcinoma
• Recurrent Endometrial Carcinoma
• Stage IA Endometrial Carcinoma
• Stage IB Endometrial Carcinoma
• Stage II Endometrial Carcinoma
• Stage IIIA Endometrial Carcinoma
• Stage IIIB Endometrial Carcinoma
• Stage IIIC Endometrial Carcinoma
• Stage IVA Endometrial Carcinoma
• Stage IVB Endometrial Carcinoma

Interventions

Type	Name	Description
DRUG	megestrol acetate	Given PO
DEVICE	levonorgestrel-releasing intrauterine system	Given IUD
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-10-01
• Completion: 2017-10-01
• First posted: 2013-09-16
• Last updated: 2014-09-10