NCT01890109

Study of Erenumab (AMG 334) in Women With Hot Flashes

Randomized, Stratified, Parallel-group, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 334 in Women With Hot Flashes Associated With Menopause

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study was to evaluate the frequency of moderate to severe daily hot flashes 4 weeks after a single dose of erenumab (AMG 334) in women with hot flashes associated with menopause.

Detailed description

This study will test the hypothesis that the vasodilation associated with capsaicin-induced dermal blood flow (DBF) provides a good model for the vasodilation associated with hot flashes; therefore erenumab doses that cause DBF inhibition will be safe and well tolerated, and will be effective in the reduction of the frequency and/or severity of HFs.

Conditions

• Vasomotor Symptoms; Hot Flashes

Interventions

Type	Name	Description
BIOLOGICAL	Erenumab	Administered via subcutaneous injection.
DRUG	Placebo	Administered via subcutaneous injection

Timeline

• Start date: 2013-05-13
• Primary completion: 2014-03-11
• Completion: 2014-03-11
• First posted: 2013-07-01
• Last updated: 2019-01-14
• Results posted: 2019-01-14

Locations

7 sites across 1 country: United States