Phase 1
Completed N=103
Study of Erenumab (AMG 334) in Women With Hot Flashes
Vasomotor Symptoms; Hot Flashes
Source: ClinicalTrials.gov NCT01890109 ↗
Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Ratio of Week 4 to Baseline Average Number of Daily Moderate to Severe Hot Flashes — 0.35; 0.38 ratio — p=0.723
Summary
The primary objective of this study was to evaluate the frequency of moderate to severe daily hot flashes 4 weeks after a single dose of erenumab (AMG 334) in women with hot flashes associated with menopause.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Week 4 to Baseline Average Number of Daily Moderate to Severe Hot Flashes |
0.35; 0.38 | 0.723 |
| SECONDARY Ratio of Week 4 to Baseline Daily Hot Flash Severity Score |
0.40; 0.45 | 0.551 |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events |
23; 24; 0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of Erenumab After a Single Dose |
6.13 | — |
| SECONDARY Time to Maximum Observed Concentration (Tmax) of Erunumab After a Single Dose |
7.0 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) for Erenumab |
173 | — |
| SECONDARY Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Erenumab |
190 | — |
| SECONDARY Terminal Half-life (T1/2) of Erenumab |
12.1 | — |
| SECONDARY Number of Participants With Treatment-emergent Suicidal Ideation |
0; 0 | — |
| SECONDARY Number of Participants Who Developed Anti-erenumab Antibodies After a Single Dose |
0; 5; 0; 4 | — |
Eligibility Criteria
Inclusion Criteria
- female subjects with hot flashes associated with menopause between 45 and 65 years of age, inclusive, with no history or evidence of clinically relevant medical disorders as determined by the investigator in consultation with the Amgen physician.
Exclusion Criteria
- History or evidence of clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Data sourced from ClinicalTrials.gov (NCT01890109). 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.