Trial · NCT01890109
Study of Erenumab (AMG 334) in Women With Hot Flashes
NCT01890109, Phase 1, Completed, Amgen; results first posted 2019-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Erenumab (AMG 334) in Women With Hot Flashes. Trials, record NCT01890109. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01890109
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Erenumab (AMG 334) in Women With Hot Flashes
- NCT number
- NCT01890109
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 103 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Vasomotor Symptoms; Hot Flashes
- Interventions
- Erenumab, Placebo
- First posted
- 2013-07-01
- Last updated
- 2019-01-14
- Results first posted
- 2019-01-14
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ratio of Week 4 to Baseline Average Number of Daily Moderate to Severe Hot Flashes | Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27) | 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 or severe hot flashes per 24 hours from day -7 to day 1 predose based on geometric mean, and the week 4 number of hot flashes is the average number of moderate or severe hot flashes per 24 hours from day 21 to day 27 based on geometric mean. The ratio of week 4 to BL was used to assess change from BL to week 4 via a log transformation (log\[week4/BL\] = log\[week4\] - log\[BL\]), which was estimated using a repeated measures analysis. The ratio was obtained via an exponential back-transformation. |
| Secondary | Ratio of Week 4 to Baseline Daily Hot Flash Severity Score | Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27) | The daily severity score was calculated according to the following: (Number of mild hot flashes \* 1) + (number of moderate hot flashes \* 2) + (number of severe hot flashes \* 3). The baseline daily hot flash severity score is the geometric mean daily hot flash severity score from day -7 to day 1 predose, and the week 4 daily hot flash severity score is the geometric mean daily hot flash severity score from day 21 to day 27. The ratio of week 4 to baseline (week 4 / baseline) was used to assess change from baseline to week 4 via a log transformation (log\[week4/BL\] = log\[week4\] - log\[baseline\]), which was estimated using a repeated measures analysis. The ratio was obtained via an exponential back-transformation. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events | 16 weeks | A treatment-emergent adverse event is any adverse event that began or worsened after the initial dose of study drug and before the end of study. A serious adverse event is an adverse event that met at least 1 of the following serious criteria: * fatal * life threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect. * other medically important serious event A treatment-related adverse event (TRAE) is any treatment-emergent adverse event that per investigator review had a reasonable possibility of being caused by the study drug. |
| Secondary | Maximum Observed Concentration (Cmax) of Erenumab After a Single Dose | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | Blood samples were analyzed using an enzyme-linked immunosorbent assay (ELISA) following a validated analytical procedure. |
| Secondary | Time to Maximum Observed Concentration (Tmax) of Erunumab After a Single Dose | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | |
| Secondary | Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) for Erenumab | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | |
| Secondary | Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Erenumab | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | |
| Secondary | Terminal Half-life (T1/2) of Erenumab | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | |
| Secondary | Number of Participants With Treatment-emergent Suicidal Ideation | 16 weeks | The Columbia Suicide Severity Rating Scale (C-SSRS) was used to assess suicidal ideation during the study based on the following Yes/No questions: 1. Have you wished you were dead or wished you could go to sleep and not wake up? 2. Have you actually had any thoughts of killing yourself? |
| Secondary | Number of Participants Who Developed Anti-erenumab Antibodies After a Single Dose | 16 weeks | Two validated assays were used to detect the presence of anti-erenumab antibodies. First, an electrochemiluminescent (ECL) bridging immunoassay was used to detect antibodies capable of binding erenumab. Second, a cell based bioassay was used to test positive binding antibody samples for neutralizing activity against erenumab. A participant was defined as positive for developing anti-erenumab antibodies if they were binding antibody positive postbaseline with a negative or no result at baseline. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the participant was defined as positive for neutralizing antibodies. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ratio of Week 4 to Baseline Average Number of Daily Moderate to Severe Hot Flashes | Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27) | All participants for whom at least 1 postdose hot flash response measure was recorded. | ratio | NUMBER |
| SECONDARY | Ratio of Week 4 to Baseline Daily Hot Flash Severity Score | Baseline (days -7 to day 1 predose) and week 4 (days 21 to 27) | All participants for whom at least 1 postdose hot flash response measure was recorded. | ratio | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events | 16 weeks | All participants who received study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Concentration (Cmax) of Erenumab After a Single Dose | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | All participants who received erenumab and for whom at least 1 pharmacokinetic (PK) parameter or endpoint could be adequately estimated. | μg/mL | MEAN |
| SECONDARY | Time to Maximum Observed Concentration (Tmax) of Erunumab After a Single Dose | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | All participants who received erenumab and for whom at least 1 pharmacokinetic (PK) parameter or endpoint could be adequately estimated. | days | MEDIAN |
| SECONDARY | Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) for Erenumab | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | All participants who received erenumab and for whom at least 1 pharmacokinetic (PK) parameter or endpoint could be adequately estimated. | day*μg/mL | MEAN |
| SECONDARY | Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) for Erenumab | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | All participants who received erenumab and for whom at least 1 pharmacokinetic (PK) parameter or endpoint could be adequately estimated. AUCinf could not be accurately estimated for 23 participants who are excluded from the analysis. | day*μg/mL | MEAN |
| SECONDARY | Terminal Half-life (T1/2) of Erenumab | Predose and 4 hours, 2, 3, 4, 8, 12, 15, 22, 29, 43, 50, 57, 64, 78, 85, and 113 days post-dose | All participants who received erenumab and for whom at least 1 PK parameter or endpoint could be adequately estimated. T1/2 could not be accurately estimated for 23 participants who are excluded from the analysis. The terminal half-life calculated from this single dose study may not be representative of a clinically relevant half-life of erenumab. | days | MEAN |
| SECONDARY | Number of Participants With Treatment-emergent Suicidal Ideation | 16 weeks | All participants who received study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Developed Anti-erenumab Antibodies After a Single Dose | 16 weeks | All participants who received study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group35
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ratio of Week 4 to Baseline Average Number of Daily Moderate to Severe Hot Flashes | Placebo | 0.35 | 95% Confidence Interval 0.24 to 0.50 | ratio | |
| Ratio of Week 4 to Baseline Average Number of Daily Moderate to Severe Hot Flashes | Erenumab | 0.38 | 95% Confidence Interval 0.26 to 0.55 | ratio | |
| Ratio of Week 4 to Baseline Daily Hot Flash Severity Score | Placebo | 0.40 | 95% Confidence Interval 0.29 to 0.53 | ratio | |
| Ratio of Week 4 to Baseline Daily Hot Flash Severity Score | Erenumab | 0.45 | 95% Confidence Interval 0.33 to 0.61 | ratio | |
| Number of Participants With Treatment-emergent Adverse Events | Placebo | Treatment-emergent adverse events (TEAEs) | 23 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Erenumab | Treatment-emergent adverse events (TEAEs) | 24 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Placebo | Serious adverse events | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Erenumab | Serious adverse events | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Placebo | TEAE leading to discontinuation of study drug | 0 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events | Erenumab | TEAE leading to discontinuation of study drug | 0 | Participants |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 52 | |
| Overall Study | STARTED | Erenumab | 51 | |
| Overall Study | Received Study Treatment | Placebo | 52 | |
| Overall Study | Received Study Treatment | Erenumab | 50 | |
| Overall Study | COMPLETED | Placebo | 51 | |
| Overall Study | COMPLETED | Erenumab | 46 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Erenumab | 5 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 2 | 52 | |
| other | Upper respiratory tract infection | Infections and infestations | Erenumab 70 mg | 3 | 50 | |
| other | Urinary tract infection | Infections and infestations | Placebo | 3 | 52 | |
| other | Urinary tract infection | Infections and infestations | Erenumab 70 mg | 0 | 50 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 0 | 52 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Erenumab 70 mg | 4 | 50 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 52 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Erenumab 70 mg | 3 | 50 | |
| other | Headache | Nervous system disorders | Placebo | 4 | 52 | |
| other | Headache | Nervous system disorders | Erenumab 70 mg | 3 | 50 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Erenumab 70 mg | ||
| Total, other adverse events | Placebo | 11 | 52 |
| Total, other adverse events | Erenumab 70 mg | 9 | 50 |
| Total, serious adverse events | Placebo | 0 | 52 |
| Total, serious adverse events | Erenumab 70 mg | 0 | 50 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Erenumab vs Placebo: Number of Participants With Treatment-emergent Suicidal Ideation | Trial comparisons |
| Erenumab 70 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01890109
GET https://conductscience.org/api/trials/v1/NCT01890109/results?page=2