CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 103 enrolled
Drug / intervention
Erenumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01890109
NCT01890109Phase 1Completed

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

Amgen·interventional·Posted Jul 1, 2013·Updated Jan 14, 2019

In Brief

A Phase 1 clinical trial evaluating Erenumab and Placebo for Vasomotor Symptoms; Hot Flashes. Completed, enrolled 103 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 1, 2013
Enrollment StartMay 13, 2013
Primary CompletionMar 11, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.0 years ago

Interventions

Erenumabbiological

Administered via subcutaneous injection.

Placebodrug

Administered via subcutaneous injection