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Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females

NCT02792517 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2018-12-20

Study results available
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Summary

A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen.

Conditions

  • Headache, Migraine

Interventions

DRUG

Erenumab

A single dose of erenumab administered in the abdomen.

DRUG

Ethynil Estradiol/Norgestimate Oral Contraceptive

Ethynil estradiol (EE)/norgestimate combination oral contraceptive is a 28-tablet cycle in which 1 oral tablet is taken daily; each containing 0.250 mg norgestimate and 0.035 mg EE for 21 days, after which a tablet only containing inert ingredients is taken for last 7 days of the 28 day cycle.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-12
Primary Completion
2016-09-09
Completion
2016-09-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02792517 on ClinicalTrials.gov