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

Completed · Phase 1

Conditions studied: Headache, Migraine

In brief

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

Key facts

Study ID

NCT02792517

Run by

Amgen

People needed

41

Starts

2016-02-12

Expected to finish

2016-09-09

Last updated by the study team

2018-12-20

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy female ≥18 to ≤45 years old at the time of enrollment
• Regular monthly menstrual cycle during the last 12 months
• Good general health based on a medical history evaluation and physical examination
• No clinically significant abnormalities in laboratory tests at screening
• Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures

You may not qualify if…

• Intolerance to any recent oral contraceptive in the last three (3) years,
• Female subjects with a positive serum pregnancy test at screening
• Female subjects not willing to inform her sexual partner of her participation in the clinical study
• Use of any over the counter or prescription medications within the 14 days or 5 half lives (whichever is longer)
• Nicotine use eg cigarettes or equivalent during 12 months prior to day 1 and through the duration of the study

Where it is running

• Research Site — Anaheim, California, United States
• Research Site — Cypress, California, United States
• Research Site — Dallas, Texas, United States
• Research Site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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