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Trial · NCT06206408

Registered outcomes18

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

ListOutcomeTime frameDescription
PrimaryMean change from baseline in the frequency of mild to severe vasomotor symptoms (VMS)Baseline and Week 8Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day.
SecondaryMean change from baseline in the frequency of mild to severe VMSBaseline and up to Week 12Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day.
SecondaryMean change from baseline in the frequency of moderate to severe VMSBaseline and up to Week 12Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day.
SecondaryMean percent reduction in the frequency of mild to severe VMS from baselineBaseline and up to Week 12Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day. Mean percent reduction will be reported.
SecondaryMean percent reduction in the frequency of moderate to severe VMS from baselineBaseline and up to Week 12Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Mean percent reduction will be reported.
SecondaryPercent reduction of >/= 50% in the frequency of mild to severe VMS from baselineBaseline and up to Week 12Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day. Percent reduction of \>/= 50% will be reported.
SecondaryPercent reduction of >/= 75% in the frequency of mild to severe VMS from baselineBaseline and up to Week 12Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day. Percent reduction of \>/= 75% will be reported.
SecondaryPercent reduction of 100% in the frequency of mild to severe VMS from baselineBaseline and up to Week 12Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day. Percent reduction of 100% will be reported.
SecondaryPercent reduction of >/= 50% in the frequency of moderate to severe VMS from baselineBaseline and up to Week 12Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction of \>/= 50% will be reported.
SecondaryPercent reduction of >/= 75% in the frequency of moderate to severe VMS from baselineBaseline and up to Week 12Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction of \>/= 75% will be reported.
SecondaryPercent reduction of 100% in the frequency of moderate to severe VMS from baselineBaseline and up to Week 12Frequency of moderate and severe VMS events will be calculated as the sum of moderate or severe VMS events per day. Percent reduction of 100% will be reported.
SecondaryNumber of participants with Adverse Events (AEs)Up to Week 15
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
SecondaryChange from baseline in endometrial thicknessBaseline and up to Week 12Endometrial thickness is a measure of how thick the lining of the uterus is. Endometrial thickness will be measured by transvaginal ultrasound (TVU).
SecondaryNumber of participants with laboratory value abnormalities and/or AEsUp to Week 15Number of participants with potentially clinically significant laboratory values.
SecondaryNumber of participants with vital sign abnormalities and/or AEsUp to Week 15Number of participants with potentially clinically significant vital sign values.
SecondaryNumber of participants with electrocardiogram (ECG) abnormalities and/or AEsUp to Week 12Number of participants with potentially clinically significant ECG values.
SecondaryPharmacokinetics (PK) of fezolinetant in plasma: ConcentrationUp to Week 12Concentration will be recorded from the PK plasma samples collected.
SecondaryPharmacokinetics (PK) of metabolite ES259564 in plasma: ConcentrationUp to Week 12Concentration will be recorded from the PK plasma samples collected.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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