This study is intended to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause.

The primary objective of this study was to establish the lowest effective dose of EstroGel® for the treatment of vasomotor symptoms associated with menopause by comparing the efficacy of 0.9 g and 1.25 g EstroGel® 0.03% doses with placebo. Effects on symptoms of vulvar and vaginal atrophy were assessed as secondary efficacy parameters.

Inclusion Criteria:

• Women 45-65 years
• naturally or surgically postmenopausal
• experiencing hot flushes

Exclusion Criteria:

• hypersensitivity to estrogen replacement therapy
• pregnancy or lactating
• abnormal PAP smear
• history/suspected cervical, uterine, adrenal, pituitary, breast or ovarian malignancy