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



Status:Completed
Conditions:Hot Flash
Therapuetic Areas:Reproductive
Healthy:No
Age Range:45 - 65
Updated:1/16/2019
Start Date:May 13, 2013
End Date:March 11, 2014

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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

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.

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
7
sites
Philadelphia, Pennsylvania 19114
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Miami, FL
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Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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Philadelphia, PA
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San Diego, CA
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Seattle, WA
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Winston-Salem, NC
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