2. If age ≤ 54 years and with the absence of normal menses for at least 24 consecutive months: Negative serum or urine (β-HCG) performed within 48 hours prior to study entry with concurrently elevated serum FSH level in the post-menopausal range, depressed estradiol (E2) level in the post-menopausal range, and absent serum progesterone level, based on the laboratory reference ranges where the hormonal assays are performed.