The purpose of this study is to determine whether RAD1901 is effective in decreasing hot flashes in postmenopausal women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Radius Health, Inc.
Cambridge, Massachusetts, United States
Percent Change in Frequency of Hot Flashes Over Time
Percent change of moderate and severe hot flash frequency at 4 weeks compared to baseline using weekly Subject diary data, in the intent-to-treat population.
Time frame: Week 4 minus baseline week
Percent Change in Composite Score Over Time
Percent change in composite score (frequency x severity) of hot flashes (Mild=1, Moderate=2, Severe=3) at 4 weeks compared to baseline, in the intent-to-treat population.
Time frame: Week 4 minus baseline week
Determine the Effects of RAD1901 on Follicular Stimulating Hormone (FSH) Over Time.
Percent change in FSH at Day 29 compared to baseline, in the intent-to-treat population.
Time frame: Day 29 minus baseline
Determine the Effects of RAD1901 on Luteinizing Hormone (LH) Over Time.
Percent change in LH levels at Day 29 compared to baseline, in the intent-to-treat population.
Time frame: Day 29 minus baseline
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100 mg Oral once a day for 28 days
Placebo Oral once a day for 28 days