Adults 40 to 65, female only, with Hot Flashes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline to Week 12 in The Weekly General Hot Flash ScorePrimary· Baseline and week 12
The HF score (based on severity and frequency) was calculated as:
(number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3)
The severity of HFs is clinically defined as follows:
* Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing.
* Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets.
* Severe:
Group
Value
95% CI
Placebo
-12.19
-16.55 – -7.83
Fezolinetant
-26.51
-30.83 – -22.18
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)Secondary· Baseline and weeks 4, 8 and 12
The HF Severity Score by method 1 takes into account the number and severity of moderate and severe HF occurred during a given time period and was calculated as follows HF Severity score = \[(number of moderate HF/day × 2) + (number of severe HF/day × 3)\]/(number of moderate HF + number of severe HF)
The severity of HFs was clinically defined as follows:
* Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets.
*
Week 4
Group
Value
95% CI
Placebo
-0.294
-0.473 – -0.116
Fezolinetant
-1.428
-1.718 – -1.138
Week 8
Group
Value
95% CI
Placebo
-0.608
-0.899 – -0.318
Fezolinetant
-1.557
-1.858 – -1.257
Week 12
Group
Value
95% CI
Placebo
-0.534
-0.798 – -0.270
Fezolinetant
-1.656
-1.937 – -1.376
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2)Secondary· Baseline and weeks 4, 8 and 12
The HF Severity Score by method 2 takes into account moderate and severe HF during a given time period and was calculated as follows HF Severity score = \[(number of moderate HF/day × 2) + (number of severe HF/day × 3)\]
The severity of HFs was clinically defined as follows:
* Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets.
* Severe: Sensation of intense heat with sweating, causing disruption of activity. I
Week 4
Group
Value
95% CI
Placebo
-9.55
-12.73 – -6.36
Fezolinetant
-25.26
-29.64 – -20.89
Week 8
Group
Value
95% CI
Placebo
-11.91
-15.72 – -8.10
Fezolinetant
-25.71
-30.15 – -21.27
Week 12
Group
Value
95% CI
Placebo
-12.14
-16.62 – -7.65
Fezolinetant
-26.61
-31.06 – -22.17
Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12Secondary· Baseline and weeks 4, 8 and 12
The weekly HF frequency was calculated as number of mild, moderate and severe hot flashes over the week.
* Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing.
* Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets.
* Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot
Week 4
Group
Value
95% CI
Placebo
-26.4
-35.2 – -17.5
Fezolinetant
-72.3
-82.7 – -61.8
Week 8
Group
Value
95% CI
Placebo
-32.9
-43.2 – -22.7
Fezolinetant
-73.3
-83.8 – -62.8
Week 12
Group
Value
95% CI
Placebo
-35.6
-46.7 – -24.5
Fezolinetant
-75.3
-86.4 – -64.3
Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12Secondary· Baseline and weeks 4, 8 and 12
The HF score (based on severity and frequency) was calculated as:
(number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3)
The severity of HFs is clinically defined as follows:
* Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing.
* Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets.
* Severe:
Week 4
Group
Value
95% CI
Placebo
22.7
10.34 – 35.11
Fezolinetant
87.8
77.79 – 97.82
Week 8
Group
Value
95% CI
Placebo
39.0
24.09 – 53.96
Fezolinetant
87.5
77.25 – 97.75
Week 12
Group
Value
95% CI
Placebo
42.5
27.18 – 57.82
Fezolinetant
95.0
88.25 – 100.00
Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12Secondary· Baseline and weeks 4, 8 and 12
The HF score (based on severity and frequency) was calculated as:
(number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3)
The severity of HFs is clinically defined as follows:
* Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing.
* Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets.
* Severe:
Week 4
Group
Value
95% CI
Placebo
9.1
0.60 – 17.59
Fezolinetant
78.0
65.38 – 90.72
Week 8
Group
Value
95% CI
Placebo
26.8
13.27 – 40.39
Fezolinetant
77.5
64.56 – 90.44
Week 12
Group
Value
95% CI
Placebo
30.0
15.80 – 44.20
Fezolinetant
87.5
77.25 – 97.75
Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12Secondary· Baseline and weeks 4, 8 and 12
The HF score (based on severity and frequency) was calculated as:
(number of mild HF/day × 1) + (number of moderate HF/day × 2) + (number of severe HF/day × 3)
The severity of HF is clinically defined as follows:
* Mild: sensation of heat without sweating/dampness. If at night, participant didn't wake up but later notices damp sheets or clothing.
* Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets.
* Severe:
Week 4
Group
Value
95% CI
Placebo
6.8
0.00 – 14.27
Fezolinetant
61.0
46.04 – 75.91
Week 8
Group
Value
95% CI
Placebo
12.2
2.18 – 22.21
Fezolinetant
60.0
44.82 – 75.18
Week 12
Group
Value
95% CI
Placebo
15.0
3.93 – 26.07
Fezolinetant
62.5
47.50 – 77.50
Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12Secondary· Baseline and weeks 4, 8 and 12
The weekly HF frequency of moderate and severe HF was calculated as number of moderate and severe HF over the week.
* Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets.
* Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed).
Higher nu
Week 4
Group
Value
95% CI
Placebo
45.5
30.74 – 60.17
Fezolinetant
95.1
88.53 – 100.00
Week 8
Group
Value
95% CI
Placebo
53.7
38.39 – 68.92
Fezolinetant
97.5
92.66 – 100.00
Week 12
Group
Value
95% CI
Placebo
55.0
39.58 – 70.42
Fezolinetant
97.5
92.66 – 100.00
Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12Secondary· Baseline and weeks 4, 8 and 12
The weekly HF frequency of moderate and severe HF was calculated as number of moderate and severe HF over the week.
* Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets.
* Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed).
Higher nu
Week 4
Group
Value
95% CI
Placebo
25.0
12.21 – 37.79
Fezolinetant
87.8
77.79 – 97.82
Week 8
Group
Value
95% CI
Placebo
46.3
31.08 – 61.61
Fezolinetant
92.5
84.34 – 100.00
Week 12
Group
Value
95% CI
Placebo
40.0
24.82 – 55.18
Fezolinetant
97.5
92.66 – 100.00
Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12Secondary· Baseline and weeks 4, 8 and 12
The weekly HF frequency of moderate and severe HF was calculated as number of moderate and severe HF over the week.
* Moderate: Sensation of heat with sweating/dampness, but was able to continue activity. If at night, participant woke up because she was feeling hot and/or was sweating, but no action was necessary other than rearranging the bed sheets.
* Severe: Sensation of intense heat with sweating, causing disruption of activity. If at night, participant woke up hot and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed).
Higher nu
Week 4
Group
Value
95% CI
Placebo
6.8
0.00 – 14.27
Fezolinetant
68.3
54.05 – 82.54
Week 8
Group
Value
95% CI
Placebo
24.4
11.25 – 37.54
Fezolinetant
67.5
52.99 – 82.01
Week 12
Group
Value
95% CI
Placebo
20.0
7.60 – 32.40
Fezolinetant
72.5
58.66 – 86.34
Change From Baseline in Hot Flash Related Daily Interference Scale (HFRDIS) Score at Weeks 4, 8 and 12Secondary· Baseline and weeks 4, 8 and 12
The HFRDIS was a 10-item scale which measured a woman's perceptions of the degree to which HF interfere with 9 daily life activities (work, social activities, leisure, sleep, mood, concentration, relations with others, sexuality, enjoying life); the 10th item measures interference with overall quality of life. This scale was modeled after items on the Brief Pain Inventory and Brief Fatigue Inventory both of which assessed the extent to which pain or fatigue interfere with daily life. Participants were asked to rate the extent to which HF had interfered with each item during the previous 4-week
Week 4: Work
Group
Value
95% CI
Placebo
-1.7
± 2.93
Fezolinetant
-4.6
± 2.65
Week 8: Work
Group
Value
95% CI
Placebo
-2.4
± 2.80
Fezolinetant
-5.0
± 2.38
Week 12: Work
Group
Value
95% CI
Placebo
-2.3
± 2.58
Fezolinetant
-4.6
± 2.68
Week 4: Social Activities
Group
Value
95% CI
Placebo
-1.6
± 2.53
Fezolinetant
-4.3
± 2.48
Week 8: Social Activities
Group
Value
95% CI
Placebo
-1.9
± 2.85
Fezolinetant
-4.7
± 2.37
Week 12: Social Activities
Group
Value
95% CI
Placebo
-1.8
± 2.51
Fezolinetant
-4.3
± 2.35
Week 4: Leisure Activities
Group
Value
95% CI
Placebo
-1.6
± 2.63
Fezolinetant
-4.0
± 2.51
Week 8: Leisure Activities
Group
Value
95% CI
Placebo
-1.7
± 2.72
Fezolinetant
-4.2
± 2.50
Change From Baseline in Leeds Sleep Evaluation Questionnaire (LSEQ) at Weeks 4, 8 and 12Secondary· Baseline and weeks 4, 8 and 12
The LSEQ was a 10-item self-rated questionnaire which assessed participants aspects of sleep and early morning behavior. The questions were grouped into 4 chronological areas: the ease of getting to sleep, the perceived quality of sleep, the ease of awaking from sleep, and the integrity of early morning behavior following wakefulness. The LSEQ was a visual analogue scale which requires respondents to place marks on a group of 10 cm lines. representing the changes they have experienced in a variety of symptoms since the beginning of treatment. Lines extends between extremes like "more difficult
Week 4: Getting to Sleep
Group
Value
95% CI
Placebo
1.017
± 1.9195
Fezolinetant
2.283
± 2.7364
Week 8: Getting to Sleep
Group
Value
95% CI
Placebo
1.145
± 1.7931
Fezolinetant
2.248
± 2.5233
Week 12: Getting to Sleep
Group
Value
95% CI
Placebo
1.282
± 1.7761
Fezolinetant
2.094
± 2.4419
Week 4: Quality of Sleep
Group
Value
95% CI
Placebo
2.145
± 2.6443
Fezolinetant
4.437
± 4.0768
Week 8: Quality of Sleep
Group
Value
95% CI
Placebo
2.378
± 2.8160
Fezolinetant
4.703
± 3.1971
Week 12: Quality of Sleep
Group
Value
95% CI
Placebo
1.904
± 2.7872
Fezolinetant
4.385
± 3.4477
Week 4: Awake Following Sleep
Group
Value
95% CI
Placebo
0.642
± 2.0739
Fezolinetant
2.180
± 3.0579
Week 8: Awake Following Sleep
Group
Value
95% CI
Placebo
0.653
± 2.5019
Fezolinetant
2.920
± 3.0219
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose of study drug until end of the study (Up to week 15).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary purpose of this study was to evaluate the effect of ESN364 on the severity and frequency of hot flashes in early postmenopausal women suffering from hot flashes, in terms of changes in weekly Hot Flash Score from baseline to Week 12.
This study also evaluated the effect of ESN364 on the severity and frequency of hot flashes at additional timepoints; hot flash interference on daily life, in terms of changes from baseline over time in Hot Flash Related Daily Interference Scale (HFRDIS); the effect of ESN364 on climacteric symptoms, in terms of changes from baseline over time in Leeds Sleep Evaluation Questionnaire (LSEQ), Greene Climacteric Scale (GCS), and Sheehan Disability Scale (SDS); pharmacodynamic (PD) effect; and safety and tolerability.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Ogeda S.A.
Last refreshed: 27 November 2024
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