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Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy

RecruitingPhase 2Ages 40 Years - anyMaleShehzad Basaria, M.D.
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy. The main questions it aims to answer are: * Does fezolinetant improve the frequency and severity of hot flashes? * Does fezolinetant cause any harm to the liver? * Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters? Researchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine. Participants will: * Take fezolinetant or a placebo every day for 4 weeks * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of the number of times and intensity that they experience hot flashes

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male sex * Age 40 years and older * Diagnosis of prostate cancer * Androgen deprivation therapy * Presence of 5 or more moderate-to-severe hot flashes per day or 35 or more moderate-to-severe hot flashes per week * Ability to sign the inform consent * Willing to use reliable methods of contraception if partner is of childbearing age * Ability to record hot flashes electronically Exclusion Criteria: * Use of abiraterone acetate * Use of docetaxel and other chemotherapeutic agents * Liver cirrhosis * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal * Total bilirubin above the upper limit of normal * Glomerular filtration rate \< 30 mL/min * Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics if prescribed for the treatment of hot flashes * Use of over-the-counter hormonal agents or herbal compounds * Current use of CYP1A2 inhibitors * Ingestion of alcohol within 2 weeks prior to the baseline visit * Inability to abstain from alcohol use during the study period.
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What it tests

  • fezolinetant - reference formulation
  • Placebo
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Where

1 site
Brigham and Women's Hospital
Boston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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