Headache, MigrainePhase 1NCT02792517

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

A Phase 1 study testing Erenumab and Ethynil Estradiol/Norgestimate Oral Contraceptive in people with Headache, Migraine, run by Amgen at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Headache, Migraine
What is being tested?: Erenumab and Ethynil Estradiol/Norgestimate Oral Contraceptive
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 4 sitesUnited States
Study dates: 12 Feb 2016to 9 Sep 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Research Site
Anaheim, California, 92801
Research Site
Cypress, California, 90630
Research Site
Dallas, Texas, 75247
Research Site
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Multi-Center, Open-label, Pharmacokinetic Drug Interaction Study of AMG 334 and a Combined Oral Contraceptive in Healthy Female Subjects

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

Read the detailed description

A pharmacokinetic (PK) drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen. All participants will receive an oral contraceptive containing progestin and estrogen throughout the duration of the study. Participants will also receive a single dose of erenumab, administered by a healthcare provider in cycle 3. Serial PK samples will be collected at specified time points to characterize the PK of the oral contraceptive progestin and estrogen components with and without the presence of erenumab.

The study consists of three 28-day cycles and a follow-up period. The first 28 day cycle is an acclimation period when participants initiate oral contraception (Cycle 1). During Cycle 2 and 3 the PK of ethinyl estradiol (EE) and active metabolites of norgestimate (ie, norelgestromin [NGMN] and norgestrel [NG]) will be characterized following the last active dose of oral contraceptive in each cycle (cycle day 21). Erenumab will be given in cycle 3 (cycle day 10); 24-hour PK characterization of norgestimate and EE metabolites will occur 11 days after administration of erenumab, which will maximize the potential for detecting a drug-drug interaction.

Conditions: Headache, Migraine
Being tested: Erenumab, Ethynil Estradiol/Norgestimate Oral Contraceptive
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ErenumabDrug
Also called AMG-334, Aimovig™
A single dose of erenumab administered in the abdomen.
Ethynil Estradiol/Norgestimate Oral ContraceptiveDrug
Also called Ortho-Cyclen®
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.

Study groups in NCT02792517
Study group	Role	What they receive
Erenumab + Estrogen/Progestin Contraceptive	Experimental	Participants received a combination oral contraceptive for 3 28-day cycles during the study. A single 140 mg dose of erenumab was administered subcutaneously to the abdomen on day 10 of cycle 3 by a healthcare provider. Receives: Drug: Erenumab; Drug: Ethynil Estradiol/Norgestimate Oral Contraceptive

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol
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.
Measured: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Ethinyl Estradiol
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.
Measured: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
Maximum Observed Plasma Concentration (Cmax) of Norgestrel
The pharmacokinetics of norgestrel (NG), an active metabolite of norgestimate, 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.
Measured: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Norgestrel
The pharmacokinetics of norgestrel (NG), an active metabolite of norgestimate, 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.
Measured: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
Maximum Observed Plasma Concentration (Cmax) of Norelgestromin
The pharmacokinetics of norelgestromin (NGMN), an active metabolite of norgestimate, 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.
Measured: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Norelgestromin
The pharmacokinetics of norelgestromin (NGMN), an active metabolite of norgestimate, 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.
Measured: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.

Secondary outcomes (5)

Time to Reach the Maximum Concentration (Tmax) of Ethinyl Estradiol
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.
Measured: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
Time to Reach the Maximum Concentration (Tmax) of Norgestrel
The pharmacokinetics of norgestrel (NG), an active metabolite of norgestimate, 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.
Measured: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
Time to Reach the Maximum Concentration (Tmax) of Norelgestromin
The pharmacokinetics of norelgestromin (NGMN), an active metabolite of norgestimate, 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.
Measured: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
Number of Participants With Treatment-emergent Adverse Events
A treatment-related adverse event (AE) is any treatment-emergent AE that per investigator review has a reasonable possibility of being caused by the study drug.
A device-related AE is any treatment-emergent AE that per investigator review has a reasonable possibility of being caused by the device (prefilled syringe) used to administer study drug.
Measured: From administration of erenumab on study day 66 through the end of the follow-up period on study day 150 (up to 84 days).
Number of Participants Who Developed Anti-erenumab Binding Antibodies
Blood samples were assessed for anti-erenumab binding antibodies. Samples testing positive for binding antibodies were also tested for neutralizing antibodies.
Measured: Baseline and day 150

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Feb 20169 Sep 2016

First posted7 Jun 2016 (estimated)
Study start12 Feb 2016
Primary completion9 Sep 2016
Study completion9 Sep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Headache, MigraineStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02792517
Sponsor's protocol ID: 20150334
Status last verified: May 2018
First submitted: 23 Feb 2016
Last updated: 20 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Xu Y, Gabriel K, Wang Y, Zhou Y, Eisele O, Vutikullird A, Mikol DD, Lee E. A Multi-Center, Open-Label, Pharmacokinetic Drug Interaction Study of Erenumab and a Combined Oral Contraceptive in Healthy Females. CNS Drugs. 2019 May;33(5):513-522. doi: 10.1007/s40263-019-00626-2.
PubMed 30963506

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Open-label, Pharmacokinetic Drug Interaction Study of AMG 334 and a Combined Oral Contraceptive in Healthy Female Subjects
ClinicalTrials.gov ID: NCT02792517
Acronym / sponsor ID: 20150334
Conditions: Headache, Migraine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 12 Feb 2016 (actual)
Primary completion: 9 Sep 2016 (actual)
Study completion: 9 Sep 2016 (actual)
First posted: 7 Jun 2016 (estimated)
Results: Posted 20 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Erenumab + Estrogen/Progestin Contraceptive	Experimental	Drug: Erenumab, Drug: Ethynil Estradiol/Norgestimate Oral ContraceptiveParticipants received a combination oral contraceptive for 3 28-day cycles during the study. A single 140 mg dose of erenumab was administered subcutaneously to the abdomen on day 10 of cycle 3 by a healthcare provider.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ErenumabAlso: AMG-334, Aimovig™A single dose of erenumab administered in the abdomen.	Drug	Erenumab + Estrogen/Progestin Contraceptive
Ethynil Estradiol/Norgestimate Oral ContraceptiveAlso: Ortho-Cyclen®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.	Drug	Erenumab + Estrogen/Progestin Contraceptive

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol
Time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
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.
Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Ethinyl Estradiol
Time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
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.
Maximum Observed Plasma Concentration (Cmax) of Norgestrel
Time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
The pharmacokinetics of norgestrel (NG), an active metabolite of norgestimate, 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.
Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Norgestrel
Time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
The pharmacokinetics of norgestrel (NG), an active metabolite of norgestimate, 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.
Maximum Observed Plasma Concentration (Cmax) of Norelgestromin
Time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
The pharmacokinetics of norelgestromin (NGMN), an active metabolite of norgestimate, 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.
Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Norelgestromin
Time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
The pharmacokinetics of norelgestromin (NGMN), an active metabolite of norgestimate, 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.

5 secondary outcomes

Time to Reach the Maximum Concentration (Tmax) of Ethinyl Estradiol
Time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
Time to Reach the Maximum Concentration (Tmax) of Norgestrel
Time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
Time to Reach the Maximum Concentration (Tmax) of Norelgestromin
Time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.
Number of Participants With Treatment-emergent Adverse Events
Time frame: From administration of erenumab on study day 66 through the end of the follow-up period on study day 150 (up to 84 days).
Number of Participants Who Developed Anti-erenumab Binding Antibodies
Time frame: Baseline and day 150

Results and safety

Results posted to the registry on 20 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erenumab 140 mg + Estrogen/Progestin Contraceptive	41	21

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol

Time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.. Mean (Standard Deviation). Unit: pg/mL

Measure	Erenumab 140 mg + Estrogen/Progestin Contraceptive n = 25
Cycle 2 (EE/norgestimate alone)	132 (46.3)
Cycle 3 (EE/norgestimate with erenumab)	143 (64.5)

Erenumab 140 mg + Estrogen/Progestin Contraceptive: Least Squares Geometric Mean Ratio: 1.04 (90% CI 0.88 to 1.22)

Population analysed: The pharmacokinetic (PK) analysis set included all participants for whom at least 1 EE, NGMN, and NG PK parameter or endpoint could be adequately estimated. Data are reported for participants with observations at each time point.

Primary outcome: Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Ethinyl Estradiol

Time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.. Mean (Standard Deviation). Unit: pg/mL*hr

Measure	Erenumab 140 mg + Estrogen/Progestin Contraceptive n = 25
Cycle 2 (EE/norgestimate alone)	1010 (367)
Cycle 3 (EE/norgestimate with erenumab)	1060 (508)

Erenumab 140 mg + Estrogen/Progestin Contraceptive: Least Squares Geometric Mean Ratio: 1.02 (90% CI 0.91 to 1.14)

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Norgestrel

Time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.. Mean (Standard Deviation). Unit: pg/mL

Measure	Erenumab 140 mg + Estrogen/Progestin Contraceptive n = 25
Cycle 2 (EE/norgestimate alone)	2690 (887)
Cycle 3 (EE/norgestimate with erenumab)	2860 (927)

Erenumab 140 mg + Estrogen/Progestin Contraceptive: Least Squares Geometric Mean Ratio: 1.06 (90% CI 0.97 to 1.16)

Primary outcome: Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Norgestrel

Time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.. Mean (Standard Deviation). Unit: pg/mL*hr

Measure	Erenumab 140 mg + Estrogen/Progestin Contraceptive n = 25
Cycle 2 (EE/norgestimate alone)	50700 (17400)
Cycle 3 (EE/norgestimate with erenumab)	52400 (17400)

Erenumab 140 mg + Estrogen/Progestin Contraceptive: Least Squares Geometric Mean Ratio: 1.03 (90% CI 0.96 to 1.10)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From administration of erenumab on study day 66 through the end of the follow-up period on study day 150 (up to 84 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erenumab 140 mg + Estrogen/Progestin Contraceptive	0 of 24 (0%)	13 of 24 (54.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30963506Xu Y, Gabriel K, Wang Y, Zhou Y, Eisele O, Vutikullird A, Mikol DD, Lee E. A Multi-Center, Open-Label, Pharmacokinetic Drug Interaction Study of Erenumab and a Combined Oral Contraceptive in Healthy Females. CNS Drugs. 2019 May;33(5):513-522. doi: 10.1007/s40263-019-00626-2.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Erenumab and Ethynil Estradiol/Norgestimate Oral Contraceptive in people with Headache, Migraine, run by Amgen at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol (time frame: Cycle 2, day 21 and cycle 3, day 21 at predose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, and 24 hours post oral contraceptive dose.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02792517, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.