The trial was conducted at 4 MsFlash network sites (Appendix 1 ). Participants were recruited from July 2009 to June 2010, primarily by mass mailing to age-eligible women on purchased mailing lists or health-plan enrollment files. Eligible women were ages 40–62 years, in the menopause transition (amenorrhea >=60 days in the past year), or postmenopausal (>=12 months since last menstrual period or bi-lateral oophorectomy), or had a hysterectomy with one or both ovaries remaining and FSH >20 mIU/mL and estradiol <=50 pg/mL; and were in general good health as determined by medical history, a brief physical exam and standard blood tests.
The required hot flash criteria were >=4 hot flashes or night sweats per day (24 hours) (an average of >=28 hot flashes/night sweats per week) recorded on daily hot flash diaries for 3 weeks in the screening period. Hot flashes/ night sweats had to be rated as bothersome (moderate or a lot) or severe (moderate or severe) on 4 or more days per week.
Exclusion criteria included use of psychotropic medications, prescription, over-the-counter, or herbal therapies for hot flashes in the past 30 days; hormone therapy, hormonal contraceptives, selective estrogen receptor modulators (SERMs) or aromatase inhibitors in the past 2 months; current severe medical illness, major depressive episode, drug or alcohol abuse in the past year; suicide attempt in the past 3 years; lifetime diagnosis of bipolar disorder or psychosis, uncontrolled hypertension, history of endometrial or ovarian cancer, myocardial infarction, angina or cerebrovascular events or lack of non-hormonal contraception if sexually active and not postmenopausal.
The required hot flash criteria were >=4 hot flashes or night sweats per day (24 hours) (an average of >=28 hot flashes/night sweats per week) recorded on daily hot flash diaries for 3 weeks in the screening period. Hot flashes/ night sweats had to be rated as bothersome (moderate or a lot) or severe (moderate or severe) on 4 or more days per week.
Exclusion criteria included use of psychotropic medications, prescription, over-the-counter, or herbal therapies for hot flashes in the past 30 days; hormone therapy, hormonal contraceptives, selective estrogen receptor modulators (SERMs) or aromatase inhibitors in the past 2 months; current severe medical illness, major depressive episode, drug or alcohol abuse in the past year; suicide attempt in the past 3 years; lifetime diagnosis of bipolar disorder or psychosis, uncontrolled hypertension, history of endometrial or ovarian cancer, myocardial infarction, angina or cerebrovascular events or lack of non-hormonal contraception if sexually active and not postmenopausal.
