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Study Complete
Sponsor ID
20120180

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

Sponsor ID
20120180
Clinicaltrials.gov ID
NCT01890109
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 334
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
103
Additional Study Details

Protocol Summary

Primary Outcome Measures

Ratio of week 4 to baseline frequency of moderate to severe daily HFs

Timeframe: 4 weeks

Secondary Outcome Measures

Ratio of week 4 to baseline daily hot flash severity score

Timeframe: 4 weeks

Number of treatment emergent adverse events per subject

Timeframe: 16 weels

The maximum observed concentration after a single dose of AMG 334

Timeframe: 16 weeks

The number of subjects with anti-AMG 334 antibodies after a single dose of AMG 334

Timeframe: 16 weeks

The time to maximum concentration after a single dose of AMG 334

Timeframe: 16 weeks

The area under the serum-concentration curve after a single dose of AMG 334

Timeframe: 16 weeks

Locations

Location
Status
Contact Us
Location
Eugene Andruczyk
Philadelphia, PA, United States, 19114
Status
Not yet recruiting
Location
Research Site
Miami, FL, United States, 33186
Status
Recruiting
Location
Research Site
Mt. Pleasant, SC, United States, 29464
Status
Recruiting
Location
Research Site
Philadelphia, PA, United States, 19114
Status
Recruiting
Location
Research Site
San Diego, CA, United States, 92108
Status
Recruiting
Location
Research Site
Seattle, WA, United States, 98105
Status
Recruiting
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Study Info
Age
45 - 65 Years
Condition
  • Menopause & Perimenopause
    • Sex
    Assigned Female at Birth
    Trial Dates
    May 2013 - Mar 2014
    Inclusion and Exclusion Criteria
    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.