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NCT01890109 · ClinicalTrials.gov registry record · Phase 1
Study of Erenumab (AMG 334) in Women With Hot Flashes
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 103
- Enrollment target
NCT01890109: Completed Phase 1 study, sponsored by Amgen.
NCT01890109 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 103 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01890109, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 103 participants
- Enrollment target
Study 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.
Primary Outcome
The severity of hot flashes was assessed by participants based on the following categories: * Mild: sensation of heat without sweating, mild flushing; * Moderate: sensation of heat, face flushed, slightly clammy, some sweating, able to continue activity, may want to remove layers of clothing or covers at night; * Severe: sensation of heat with more severe sweating, have to stop current activity, may have to change clothing. Baseline (BL) number of hot flashes is the average number of moderate
Interventions
- DRUG Placebo
- BIOLOGICAL Erenumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2013-05-13 |
| Est. Completion | 2014-03-11 |
| Phase | Phase 1 |
What the finished NCT01890109 record still lists
NCT01890109 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01890109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01890109 about?
NCT01890109 is a clinical study titled "Study of Erenumab (AMG 334) in Women With Hot Flashes". 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.
What is the current status of trial NCT01890109?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 103 participants. The study started on 2013-05-13. Estimated completion is 2014-03-11.
What interventions are being tested in trial NCT01890109?
The interventions under investigation include: Placebo (DRUG), Erenumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01890109?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01890109's enrollment target sits among peer trials
103 541st of 2000 higher than 1,458 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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