- Postmenopausal as defined by 6 months of spontaneous amenorrhea with serum FSH levels
>40mlU/ml and estradiol
oophorectomy with or without hysterectomy and FSH levels > 40 mlU/ml and estradiol
than = 25 pg/mL
- Women reporting at least 50 moderate to severe vasomotor symptoms per week, recorded
for seven consecutive days
- Aged 40 to 70 years
- No estrogen monotherapy or estrogen/progesterone containing drug products within
applicable wash out period prior to screening
- Use of SERMs, clonidine within 4 weeks of screening
- Use of CNS active medication within 1 week of screening
- Use of medications (SSRI; SNRI), herbal or dietary supplements, including black
cohosh, soy, phytoestrogens or over the counter agent known to possibly be effective
for the treatment of vasomotor symptoms, within 4 weeks of screening
- Participation in clinical trial within 30 days
- Significant medical or psychiatric illness within past 12 months