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A Phase II Study of the Biologic Effect of Levonorgestrel on the Ovarian Epithelium in Women at High Risk for Ovarian Cancer
[Protocol 08-150]
- Full Title :
- PHASE II DOUBLE BLIND RANDOMIZED TRIAL EVALUATING THE BIOLOGIC EFFECT OF LEVONORGESTREL ON THE OVARIAN EPITHELIUM IN WOMEN AT HIGH RISK FOR OVARIAN CANCER (GOG-214)(IND#79,610)
- Purpose :
Studies have shown that taking oral contraceptives reduces the risk of developing ovarian cancer, but the mechanism underlying this effect is not clearly understood. Most ovarian cancers start growing in a thin layer of cells on the surface of the ovary (epithelium). New studies show that progestins (hormones in birth control pills) may cause changes in ovarian epithelial cells which may keep them from becoming cancerous.
In this study, researchers want to determine the effects of levonorgestrel, a hormone used in birth control pills, on ovarian epithelial cells in women with a high risk of ovarian cancer who are scheduled to have their ovaries and fallopian tubes removed to reduce their risk. Women will be randomly assigned to receive levonorgestrel or a placebo for 4 to 6 weeks before surgery. Tissue samples from the two groups will be compared to determine the effects of levonorgestrel on ovarian epithelial cells.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have an increased genetic risk of ovarian cancer due to a BRCA mutation or family history and be planning to have risk-reducing surgery involving removal of the ovaries and fallopian tubes.
- Patients taking hormonal therapy or using hormonal contraception may not participate.
- Patients who are current smokers or who have a history of deep vein thrombosis, stroke, liver disease, or heart attack may not participate.
- Patients must be age 30 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Noah Kauff at 646-888-4082.
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