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
1 other identifier
interventional
103
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2013
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2013
CompletedStudy Start
First participant enrolled
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2014
CompletedResults Posted
Study results publicly available
January 14, 2019
CompletedJanuary 14, 2019
January 1, 2019
10 months
May 13, 2013
May 21, 2018
January 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ratio of Week 4 to Baseline Average Number of Daily Moderate to Severe Hot Flashes
The severity of hot flashes was assessed by participants based on the following categories: * Mild: sensation of heat without sweating, mild flushing; * Moderate: sensation of heat, face flushed, slightly clammy, some sweating, able to continue activity, may want to remove layers of clothing or covers at night; * Severe: sensation of heat with more severe sweating, have to stop current activity, may have to change clothing. Baseline (BL) number of hot flashes is the average number of moderate or severe hot flashes per 24 hours from day -7 to day 1 predose based on geometric mean, and the week 4 number of hot flashes is the average number of moderate or severe hot flashes per 24 hours from day 21 to day 27 based on geometric mean. The ratio of week 4 to BL was used to assess change from BL to week 4 via a log transformation (log\[week4/BL\] = log\[week4\] - log\[BL\]), which was estimated using a repeated measures analysis. The ratio was obtained via an exponential back-transformation.
Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27)
Secondary Outcomes (9)
Ratio of Week 4 to Baseline Daily Hot Flash Severity Score
Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27)
Number of Participants With Treatment-emergent Adverse Events
16 weeks
Maximum Observed Concentration (Cmax) of Erenumab After a Single Dose
Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
Time to Maximum Observed Concentration (Tmax) of Erunumab After a Single Dose
Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) for Erenumab
Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose
- +4 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants received a single dose of placebo administered by subcutaneous injection.
Erenumab
EXPERIMENTALParticipants received a single dose of 70 mg erenumab administered by subcutaneous injection.
Interventions
Eligibility Criteria
You may qualify if:
- female subjects with hot flashes associated with menopause between 45 and 65 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician.
You may not qualify if:
- History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (7)
Research Site
San Diego, California, 92108, United States
Research Site
Miami, Florida, 33186, United States
Research Site
Winston-Salem, North Carolina, 27103, United States
Eugene Andruczyk
Philadelphia, Pennsylvania, 19114, United States
Research Site
Philadelphia, Pennsylvania, 19114, United States
Research Site
Mt. Pleasant, South Carolina, 29464, United States
Research Site
Seattle, Washington, 98105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2013
First Posted
July 1, 2013
Study Start
May 13, 2013
Primary Completion
March 11, 2014
Study Completion
March 11, 2014
Last Updated
January 14, 2019
Results First Posted
January 14, 2019
Record last verified: 2019-01