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

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Amgen

Status and phase

Completed
Phase 1

Conditions

Vasomotor Symptoms; Hot Flashes

Treatments

Biological: Erenumab
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01890109
20120180

Details and patient eligibility

About

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.

Full 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.

Enrollment

103 patients

Sex

Female

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

103 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Participants received a single dose of placebo administered by subcutaneous injection.
Treatment:
Drug: Placebo
Erenumab
Experimental group
Description:
Participants received a single dose of 70 mg erenumab administered by subcutaneous injection.
Treatment:
Biological: Erenumab

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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