Permanent discontinuation of study medication was required by protocol
for women who developed breast cancer, endometrial pathologic state (hyperplasia not responsive to treatment, atypia, or cancer), deep vein thrombosis (DVT) or PE, malignant melanoma, meningioma, triglyceride level greater than 1000 mg / dL (11.3 mmol / L), or prescription of
estrogen, testosterone, or selective
estrogen -
receptor modulators by their personal physician.