Trial · NCT05419908

Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes

NCT05419908, Phase 2, Completed, Ogeda S.A.; results first posted 2023-07-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes. Trials, record NCT05419908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05419908

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
NCT number: NCT05419908
Status: Completed
Phases: Phase 2
Enrollment: 87 participants, actual
Lead sponsor: Ogeda S.A.
Conditions: Hot Flashes
Interventions: Fezolinetant, Placebo
First posted: 2022-06-15
Last updated: 2024-11-27
Other registries' IDs: eudract:2015-002578-20
Results first posted: 2023-07-25

Source ClinicalTrials.gov

Registered outcomes26

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 12 in The Weekly General Hot Flash Score	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: 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 scores indicate worse symptoms. There is no maximum score since the score was participant dependent for both number and severity.
Secondary	Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)	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. * 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 scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Secondary	Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2)	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. 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 scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Secondary	Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12	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 and was sweating and needed to take action (e.g., removing layers of clothes, open the window, or get out of bed). Higher number of hot flashes is worse.
Secondary	Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12	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: 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 scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Secondary	Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12	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: 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 scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Secondary	Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12	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: 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 scores indicate worse symptoms. There is no maximum score since the score was participant-dependent for both number and severity.
Secondary	Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12	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 number of HF indicates worse symptoms.
Secondary	Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12	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 number of HF indicates worse symptoms.
Secondary	Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12	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 number of HF indicates worse symptoms.

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 12 in The Weekly General Hot Flash Score	Baseline and week 12	Intent-to-treat (ITT) population (included all randomized participants who received at least one dose of the study medication and who had post-baseline efficacy data) with available data at specified time point.	score on a scale	MEAN
SECONDARY	Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)	Baseline and weeks 4, 8 and 12	ITT population with available data at specified time point.	score on a scale	MEAN
SECONDARY	Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2)	Baseline and weeks 4, 8 and 12	ITT population with available data at specified time point.	score on a scale	MEAN
SECONDARY	Change From Baseline in The Weekly Mild, Moderate and Severe Hot Flash Frequency at Weeks 4, 8 and 12	Baseline and weeks 4, 8 and 12	ITT population with available data at specified time point.	HF's per day	MEAN
SECONDARY	Percentage of Participants With >=70% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12	Baseline and weeks 4, 8 and 12	ITT population with available data at specified time point.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With >=80% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12	Baseline and weeks 4, 8 and 12	ITT population with available data at specified time point.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With >=90% Reduction in the Weekly Hot Flash Score From Baseline to Weeks 4, 8 and 12	Baseline and weeks 4, 8 and 12	ITT population with available data at specified time point.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With >=50% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12	Baseline and weeks 4, 8 and 12	ITT population with available data at specified time point.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With >=70% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12	Baseline and weeks 4, 8 and 12	ITT population with available data at specified time point.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With >=90% Reduction in the Weekly Frequency of Moderate and Severe HF From Baseline to Weeks 4, 8 and 12	Baseline and weeks 4, 8 and 12	ITT population with available data at specified time point.	percentage of participants	NUMBER

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group300

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline to Week 12 in The Weekly General Hot Flash Score	Placebo		-12.19	95% Confidence Interval -16.55 to -7.83	score on a scale
Change From Baseline to Week 12 in The Weekly General Hot Flash Score	Fezolinetant		-26.51	95% Confidence Interval -30.83 to -22.18	score on a scale
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)	Placebo	Week 4	-0.294	95% Confidence Interval -0.473 to -0.116	score on a scale
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)	Fezolinetant	Week 4	-1.428	95% Confidence Interval -1.718 to -1.138	score on a scale
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)	Placebo	Week 8	-0.608	95% Confidence Interval -0.899 to -0.318	score on a scale
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)	Fezolinetant	Week 8	-1.557	95% Confidence Interval -1.858 to -1.257	score on a scale
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)	Placebo	Week 12	-0.534	95% Confidence Interval -0.798 to -0.270	score on a scale
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 1)	Fezolinetant	Week 12	-1.656	95% Confidence Interval -1.937 to -1.376	score on a scale
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2)	Placebo	Week 4	-9.55	95% Confidence Interval -12.73 to -6.36	score on a scale
Change From Baseline in The Weekly Hot Flash Severity Score at Weeks 4, 8 and 12 (Method 2)	Fezolinetant	Week 4	-25.26	95% Confidence Interval -29.64 to -20.89	score on a scale

1 to 10 of 300Source ClinicalTrials.gov

See all 300 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	44
Overall Study	STARTED	Fezolinetant	43
Overall Study	COMPLETED	Placebo	40
Overall Study	COMPLETED	Fezolinetant	40
Overall Study	NOT COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	Fezolinetant	3

Source ClinicalTrials.gov

Adverse events18

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	Palpitations	Cardiac disorders	Placebo	2	44	2
other	Palpitations	Cardiac disorders	Fezolinetant	3	43	3
other	Diarrhoea	Gastrointestinal disorders	Placebo	0	44	0
other	Diarrhoea	Gastrointestinal disorders	Fezolinetant	3	43	3
other	Fatigue	General disorders	Placebo	0	44	0
other	Fatigue	General disorders	Fezolinetant	3	43	3
other	Influenza	Infections and infestations	Placebo	1	44	1
other	Influenza	Infections and infestations	Fezolinetant	3	43	3
other	Nasopharyngitis	Infections and infestations	Placebo	4	44	4
other	Nasopharyngitis	Infections and infestations	Fezolinetant	2	43	2

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	44
Total, all-cause mortality	Fezolinetant	0	43
Total, other adverse events	Placebo	18	44
Total, other adverse events	Fezolinetant	18	43
Total, serious adverse events	Placebo	1	44
Total, serious adverse events	Fezolinetant	0	43

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31415087	RESULT

Source PubMed

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
Fezolinetant vs Placebo: deaths from any cause	Trial comparisons
Fezolinetant 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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