At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 41 enrolled
Drug / intervention
Erenumab +1 moredrug
Likely dose
Ethynil Estradiol/Norgestimate Oral Contraceptive 0.250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Open-label, Pharmacokinetic Drug Interaction Study of AMG 334 and a Combined Oral Contraceptive in Healthy Female Subjects
In Brief
A Phase 1 clinical trial evaluating Erenumab and Ethynil Estradiol/Norgestimate Oral Contraceptive for Headache, Migraine. Completed, enrolled 41 participants across 4 sites.
Detailed Summary
A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeadache, Migraine
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedJun 2016
Primary CompletionSep 2016
TodayJul 2026
First PostedJun 7, 2016
Enrollment StartFeb 12, 2016
Primary CompletionSep 9, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.1 years ago
Interventions
Erenumabdrug
A single dose of erenumab administered in the abdomen.
Ethynil Estradiol/Norgestimate Oral Contraceptivedrug
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.