Status:
COMPLETED
Study of Erenumab (AMG 334) in Women With Hot Flashes
Lead Sponsor:
Amgen
Conditions:
Vasomotor Symptoms; Hot Flashes
Eligibility:
FEMALE
45-65 years
Phase:
PHASE1
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 me...
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 er...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 13 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2014
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01890109
Start Date
May 13 2013
End Date
March 11 2014
Last Update
January 14 2019
Active Locations (7)
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1
Research Site
San Diego, California, United States, 92108
2
Research Site
Miami, Florida, United States, 33186
3
Research Site
Winston-Salem, North Carolina, United States, 27103
4
Eugene Andruczyk
Philadelphia, Pennsylvania, United States, 19114