NCT02653417

Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms

A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety and Efficacy of RAD1901 in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: Radius Pharmaceuticals, Inc. · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vasomotor Symptoms
• Hot Flashes

Interventions

Type	Name	Description
DRUG	RAD1901	RAD1901
OTHER	Placebo	Placebo

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-12-12
• Completion: 2018-05-01
• First posted: 2016-01-12
• Last updated: 2019-03-13
• Results posted: 2019-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study