Phase 1
Completed N=41
Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females
Headache, Migraine
Source: ClinicalTrials.gov NCT02792517 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol — 132; 143 pg/mL
Summary
A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing progestin and estrogen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol |
132; 143 | — |
| PRIMARY Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Ethinyl Estradiol |
1010; 1060 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Norgestrel |
2690; 2860 | — |
| PRIMARY Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Norgestrel |
50700; 52400 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Norelgestromin |
1800; 1870 | — |
| PRIMARY Area Under the Plasma Concentration Time Curve From Time 0 to 24 Hours Postdose (AUCtau) for Norelgestromin |
16800; 16900 | — |
| SECONDARY Time to Reach the Maximum Concentration (Tmax) of Ethinyl Estradiol |
1.0; 1.0 | — |
| SECONDARY Time to Reach the Maximum Concentration (Tmax) of Norgestrel |
1.5; 1.5 | — |
| SECONDARY Time to Reach the Maximum Concentration (Tmax) of Norelgestromin |
1.0; 1.0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events |
17; 0; 0; 2; 0; 1 | — |
| SECONDARY Number of Participants Who Developed Anti-erenumab Binding Antibodies |
2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02792517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.