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

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ClinicalTrials.gov Identifier: NCT01890109
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Vasomotor Symptoms; Hot Flashes Biological: Erenumab Drug: Placebo Phase 1

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : May 13, 2013
Actual Primary Completion Date : March 11, 2014
Actual Study Completion Date : March 11, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received a single dose of placebo administered by subcutaneous injection.
Drug: Placebo
Administered via subcutaneous injection
Experimental: Erenumab
Participants received a single dose of 70 mg erenumab administered by subcutaneous injection.
Biological: Erenumab
Administered via subcutaneous injection.
Other Names:
  • AMG 334
  • Aimovig™



Primary Outcome Measures :
  1. Ratio of week 4 to baseline frequency of moderate to severe daily HFs [ Time Frame: 4 weeks ]
    The 4-week endpoint frequency is defined as the average hot flash frequency over 7 days between weeks 3 and 4


Secondary Outcome Measures :
  1. Ratio of week 4 to baseline daily hot flash severity score [ Time Frame: 4 weeks ]
  2. Number of treatment emergent adverse events per subject [ Time Frame: 16 weels ]
  3. The maximum observed concentration after a single dose of AMG 334 [ Time Frame: 16 weeks ]
  4. The number of subjects with anti-AMG 334 antibodies after a single dose of AMG 334 [ Time Frame: 16 weeks ]
  5. The time to maximum concentration after a single dose of AMG 334 [ Time Frame: 16 weeks ]
  6. The area under the serum-concentration curve after a single dose of AMG 334 [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890109


Locations
United States, California
Research Site
San Diego, California, United States, 92108
United States, Florida
Research Site
Miami, Florida, United States, 33186
United States, North Carolina
Research Site
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Eugene Andruczyk
Philadelphia, Pennsylvania, United States, 19114
Research Site
Philadelphia, Pennsylvania, United States, 19114
United States, South Carolina
Research Site
Mount Pleasant, South Carolina, United States, 29464
United States, Washington
Research Site
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01890109     History of Changes
Other Study ID Numbers: 20120180
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Keywords provided by Amgen:
Vasomotor symptoms; Hot Flashes; Menopause

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms