Trial · NCT04451226
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Up to 55 weeks | An adverse event (AE) is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. |
| Primary | Number of Participants With Adverse Events Based on Severity | Up to 55 weeks | An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. |
| Secondary | Change From Baseline in Endometrial Thickness | Baseline and 52 weeks | Endometrial thickness is a measure of how thick the lining of the uterus is. Change from baseline will be reported. |
| Secondary | Percentage of Participants With Endometrial Hyperplasia and/or Endometrial Cancer | Up to 52 weeks | Endometrial hyperplasia is thickening of the lining of the uterus. Endometrial cancer is cancer of the lining of the uterus. Percentage of participants will be reported. |
| Secondary | Number of Participants With Vital Sign Abnormalities and/or Adverse Events (AEs) | Up to 55 weeks | Number of participants with potentially clinically significant vital sign values. |
| Secondary | Number of Participants With Laboratory Value Abnormalities and/or Adverse Events (AEs) | Up to 55 weeks | Number of participants with potentially clinically significant laboratory values. |
| Secondary | Number of Participants With Suicidal Ideation and/or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 55 weeks | The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an affirmative response provided to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) will be reported. |
| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities and/or Adverse Events (AEs) | Up to 52 weeks | Number of participants with potentially clinically significant ECG values. |
| Secondary | Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) Levels | Baseline, week 52 and week 55 | Change from baseline in serum concentrations of BSAP will be reported. |
| Secondary | Change From Baseline in Procollagen Type 1 Amino-terminal Propeptide (P1NP) Levels | Baseline, week 52 and week 55 | Change from baseline in serum concentrations of P1NP will be reported. |
| Secondary | Change From Baseline in Carboxy-terminal Telopeptide of Type I Collagen (CTX) Levels | Baseline, week 52 and week 55 | Change from baseline in serum concentrations of CTX will be reported. |
| Secondary | Change From Baseline in Serum Concentration of Sex Hormones | Baseline, week 4, week 12, week 24 , week 52 and week 55 | Change from baseline in serum concentration of sex hormones will be reported. |
| Secondary | Change From Baseline in Sex Hormone-Binding Globulin (SHBG) | Baseline, week 4, week 12, week 24 , week 52 and week 55 | Change from baseline in serum concentration of SHBG will be reported. |
| Secondary | Pharmacokinetics (PK) of Fezolinetant in Plasma: Concentration | Week 4, week 12, week 24 and week 52 | Concentration will be recorded from the PK plasma samples collected. |
| Secondary | Pharmacokinetics (PK) of Fezolinetant Metabolite ES259564 in Plasma: Concentration | Week 4, week 12, week 24 and week 52 | 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04451226/registered