This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,251
oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT
Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4
Time frame: 4 weeks
Mean change in frequency of moderate to severe VMS from baseline to Week 12
Time frame: 12 weeks
Mean change in severity of moderate to severe VMS from baseline to Week 4
Time frame: 4 weeks
Mean change in severity of moderate to severe VMS from baseline to Week 12
Time frame: 12 weeks
Frequency and severity of moderate to severe and all hot flushes at each week
Time frame: 12 weeks
Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome
Time frame: 12 weeks
Mean change from baseline to Week 12 in vaginal pH
Time frame: 12 weeks
Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells)
Time frame: 12 weeks
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oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT
oral tablet, QD, 12 weeks, 0.30 EE
oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT
oral tablet, QD, 12 weeks, 0.45 EE
oral tablet, QD, 12 weeks, 0.60 MT
oral tablet, QD, 12 weeks, Placebo
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