The primary objective of this study was to determine the clinical safety of RAD1901 and to evaluate whether RAD1901 reduced the frequency and severity of moderate to severe vasomotor symptoms (VMS; "hot flashes") in postmenopausal women.
This was a Phase 2b outpatient, prospective, multicenter, double-blind, randomized, placebo-controlled study to determine whether elacestrant reduces the frequency and severity of vasomotor symptoms (VMS; "hot flashes") in postmenopausal women with moderate to severe hot flashes. Postmenopausal women who met study criteria were followed for 12 weeks on double-blind study medication and two weeks off study medication. Treatment was randomized 1:1:1:1 to ensure that an approximately equal number of patients were exposed to each of three RAD1901 (elacestrant) doses (5, 10 and 20 mg/day) or placebo. The total period of placebo exposure was 14 weeks. Enrolling approximately 300 patients was expected to provide power for testing superiority of the primary efficacy endpoint outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
139
Women's Health Care Specialists P.C. - Beyer Research
Kalamazoo, Michigan, United States
Change From Baseline to Week 12 in the Frequency of Moderate to Severe Hot Flashes
Change from baseline to week 12 in the average number of moderate and severe hot flashes per day, where change is calculated as week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency. Severity of hot flashes was self-assessed and reported as follows: * Mild: sensation of heat without sweating * Moderate: sensation of heat with sweating, able to continue activity * Severe: sensation of heat with sweating, causing cessation of activity.
Time frame: Baseline and 12 weeks
Change From Baseline to Week 4 in the Frequency of Moderate to Severe Hot Flashes
Change from baseline to week 4 in the average number of moderate and severe hot flashes per day, where change is calculated as week 4 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency.
Time frame: Baseline and 4 weeks
Change From Baseline to Week 4 and Week 12 in the Severity of Hot Flashes
Change from baseline to week 4 and week 12 in the average daily severity of hot flashes, where change is calculated as week 4 or week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash severity. Subjects recorded the number of hot flashes per day using an electronic diary. Daily severity score for hot flashes for each subject was calculated as the sum of the number of mild hot flashes, plus 2 times the number of moderate hot flashes, plus 3 times the number of severe hot flashes, divided by the total number of mild, moderate, and severe hot flashes. That is, Daily Severity Score = (Fmild + 2•Fmod + 3•Fsev)/(Fmild + Fmod + Fsev) where Fmild= frequency of mild hot flashes, Fmod = frequency of moderate hot flashes, Fsev = frequency of severe hot flashes. The measure is a weighted average of the frequencies of Hot Flashes.
Time frame: Baseline, 4 weeks, and 12 weeks
Change From Baseline to Week 4 and Week 12 in the Frequency of All Hot Flashes
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Change from baseline to week 4 and week 12 in the average number of all hot flashes (mild, moderate, and severe) by eDiary, where change is calculated as week 4 or week 12 minus baseline so that negative values indicate a reduction (improvement) of hot flash frequency.
Time frame: Baseline, 4 weeks, and 12 weeks