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NCT02792517 · ClinicalTrials.gov registry record · Phase 1
Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females
A Phase 1 study of Headache, Migraine, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 4
- Study locations
NCT02792517: Completed Phase 1 study of Headache, Migraine, sponsored by Amgen.
NCT02792517 is a Phase 1 study of Headache, Migraine that has completed, run by Amgen. The registered enrollment target is 41 participants, below the 248-participant average among 7 other Headache, Migraine trials with a reported enrollment target (83% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02792517, a Phase 1 study of Headache, Migraine, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 4
- Study locations
Study Summary
A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen.
Primary Outcome
The pharmacokinetics of ethinyl estradiol (EE) were characterized during cycle 2 following the last active dose of oral contraceptive in the cycle (cycle day 21) without erenumab, and during cycle 3 following the last active dose of oral contraceptive in the cycle (cycle day 21), 11 days after a single dose of erenumab.
Conditions Studied
Interventions
- DRUG Erenumab
- DRUG Ethynil Estradiol/Norgestimate Oral Contraceptive
Study Locations (4)
California
- Research Site - Anaheim
- Research Site - Cypress
Texas
- Research Site - Dallas
Wisconsin
- Research Site - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2016-02-12 |
| Est. Completion | 2016-09-09 |
| Phase | Phase 1 |
What the finished NCT02792517 record still lists
NCT02792517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 248-participant average among 7 other Headache, Migraine trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Headache, Migraine appearing as the primary indexed condition, and to 2 interventions - of which Erenumab is the first listed.
NCT02792517 reports a single indexed study location in California, Texas, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT02792517 about?
NCT02792517 is a clinical study titled "Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females". A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen.
What is the current status of trial NCT02792517?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2016-02-12. Estimated completion is 2016-09-09.
What conditions does trial NCT02792517 study?
This clinical trial studies the following conditions: Headache, Migraine.
What interventions are being tested in trial NCT02792517?
The interventions under investigation include: Erenumab (DRUG), Ethynil Estradiol/Norgestimate Oral Contraceptive (DRUG).
Who is sponsoring clinical trial NCT02792517?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02792517 being conducted?
This trial has 4 study locations across California, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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