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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-13

Study Completion Date

2014-03-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vasomotor Symptoms; Hot Flashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Participants received a single dose of placebo administered by subcutaneous injection.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered via subcutaneous injection

Erenumab

Participants received a single dose of 70 mg erenumab administered by subcutaneous injection.

Group Type EXPERIMENTAL

Erenumab

Intervention Type BIOLOGICAL

Administered via subcutaneous injection.

Interventions

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Erenumab

Administered via subcutaneous injection.

Intervention Type BIOLOGICAL

Placebo

Administered via subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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AMG 334 Aimovig™

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No