Conditions: Vasomotor Symptoms Hot Flashes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 139
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: RAD1901 5 mg/day arm 2: RAD1901 10 mg/day arm 3: RAD1901 20 mg/day arm 4: Placebo

Interventions: intervention 1: RAD1901 intervention 2: Placebo
Intervention descriptions: intervention 1: RAD1901 intervention 2: Placebo

Protocol document: