Trial · NCT06206408
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean change from baseline in the frequency of mild to severe vasomotor symptoms (VMS) | Baseline and Week 8 | Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day. |
| Secondary | Mean change from baseline in the frequency of mild to severe VMS | Baseline and up to Week 12 | Frequency of mild, moderate or severe VMS events will be calculated as the sum of mild, moderate or severe VMS events per day. |
| Secondary | Mean change from baseline in the frequency of moderate to severe VMS | Baseline and up to Week 12 | Frequency of moderate or severe VMS events will be calculated as the sum of moderate or severe VMS events per day. |
| Secondary | Mean percent reduction in the frequency of mild to severe VMS from baseline | Baseline and up to Week 12 | Frequency 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. |
| Secondary | Mean percent reduction in the frequency of moderate to severe VMS from baseline | Baseline and up to Week 12 | Frequency 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. |
| Secondary | Percent reduction of >/= 50% in the frequency of mild to severe VMS from baseline | Baseline and up to Week 12 | Frequency 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. |
| Secondary | Percent reduction of >/= 75% in the frequency of mild to severe VMS from baseline | Baseline and up to Week 12 | Frequency 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. |
| Secondary | Percent reduction of 100% in the frequency of mild to severe VMS from baseline | Baseline and up to Week 12 | Frequency 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. |
| Secondary | Percent reduction of >/= 50% in the frequency of moderate to severe VMS from baseline | Baseline and up to Week 12 | Frequency 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. |
| Secondary | Percent reduction of >/= 75% in the frequency of moderate to severe VMS from baseline | Baseline and up to Week 12 | Frequency 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. |
| Secondary | Percent reduction of 100% in the frequency of moderate to severe VMS from baseline | Baseline and up to Week 12 | Frequency 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. |
| Secondary | Number 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. |
| Secondary | Change from baseline in endometrial thickness | Baseline and up to Week 12 | Endometrial thickness is a measure of how thick the lining of the uterus is. Endometrial thickness will be measured by transvaginal ultrasound (TVU). |
| Secondary | Number of participants with laboratory value abnormalities and/or AEs | Up to Week 15 | Number of participants with potentially clinically significant laboratory values. |
| Secondary | Number of participants with vital sign abnormalities and/or AEs | Up to Week 15 | Number of participants with potentially clinically significant vital sign values. |
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities and/or AEs | Up to Week 12 | Number of participants with potentially clinically significant ECG values. |
| Secondary | Pharmacokinetics (PK) of fezolinetant in plasma: Concentration | Up to Week 12 | Concentration will be recorded from the PK plasma samples collected. |
| Secondary | Pharmacokinetics (PK) of metabolite ES259564 in plasma: Concentration | Up to Week 12 | Concentration 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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT06206408/registered