NCT00445887

Levonorgestrel in Preventing Ovarian Cancer in Patients at High Risk for Ovarian Cancer

Phase II Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Double Blind Randomized Trial Evaluating the Biologic Effect of Levonorgestrel on the Ovarian Epithelium in Women at High Risk for Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial is studying how well levonorgestrel works in preventing ovarian cancer in patients at high risk for ovarian cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of levonorgestrel may prevent ovarian cancer.

Detailed description

PRIMARY OBJECTIVES: I. Determine the impact of levonorgestrel on the relative frequency of apoptosis in the ovarian epithelium of patients at high risk for ovarian cancer. SECONDARY OBJECTIVES: I. Estimate the impact of this drug on proliferation and transforming growth factor-beta (TGF-beta) expression in the ovarian epithelium of these patients. II. Assess the safety of this drug in these patients. OUTLINE: This is a prospective, randomized, placebo-controlled, double-blind study. Patients are stratified according to menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral levonorgestrel once daily. ARM II: Patients receive oral placebo once daily. In both arms, treatment continues for 4-6 weeks in the absence of disease progression or unacceptable toxicity, including on the day of surgery. Patients then undergo prophylactic salpingo-oophorectomy. After completion of study therapy, patients are followed at 1 year. NOTE: \* Patients who are unable to have surgery completed during the expected 4-6 weeks, may continue levonorgestrel or placebo for a time period no \> 5 months. Patients unable to undergo surgery within 5 months are removed from the study.

Conditions

• Ovarian Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Levonorgestrel	Given orally
OTHER	Placebo	Given orally

Timeline

• Start date: 2008-03-10
• Primary completion: 2013-12-11
• First posted: 2007-03-09
• Last updated: 2019-11-19
• Results posted: 2018-01-11

Locations

66 sites across 1 country: United States