Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT.
Kimball A Johnson, Nancy Martin, Rossella E Nappi...
https://pubmed.ncbi.nlm.nih.gov/36734148Actively Recruiting
Phase 2
Age: 40Years +
MALE
ID06957691
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
Led by Shehzad Basaria, M.D. · Updated on 2026-03-09
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
S
Shehzad Basaria, M.D.
Lead Sponsor
A
Astellas Pharma US, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating fezolinetant, a selective neurokinin 3 (NK3) receptor antagonist, to see if it can reduce hot flashes in men with prostate cancer who are undergoing androgen deprivation therapy. This therapy lowers male hormone levels but often causes bothersome hot flashes that affect quality of life, sleep, mood, sexual function, and metabolism. The trial aims to compare fezolinetant's effects with a placebo and assess its impact on liver safety and symptom improvement. Participants will take either 45 mg of oral fezolinetant or a placebo once daily for 4 weeks. During this time, they will attend clinic visits every 2 weeks for checkups and tests. They will also keep a daily diary recording the frequency and severity of hot flashes. The study uses a randomized design with quadruple masking to compare the two groups. Throughout the study, researchers will monitor changes in hot flash frequency and liver function from baseline to 4 weeks. Secondary assessments include quality of life, sleep quality, mood, sexual function, fatigue, inflammation markers, and metabolic measures like glucose and lipid levels. Participants' adherence and symptoms will be tracked with diaries and questionnaires to evaluate treatment effects and safety over the one-month treatment period.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 40Years +
MALE
Eligibility Criteria
You may qualify if you...
- Male sex
- Age 40 years and older
- Diagnosis of prostate cancer
- Undergoing androgen deprivation therapy
- Experiencing 5 or more moderate-to-severe hot flashes per day or 35 or more per week
- Able to sign informed consent
- Willing to use reliable contraception if partner is of childbearing age
- Able to record hot flashes electronically
You will not qualify if you...
- Use of abiraterone acetate
- Use of docetaxel or other chemotherapy drugs
- Liver cirrhosis
- Elevated liver enzymes (ALT or AST) above normal limits
- Elevated total bilirubin above normal limits
- Glomerular filtration rate less than 30 mL/min
- Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics
- Use of over-the-counter hormonal or herbal products
- Current use of CYP1A2 inhibitors
- Alcohol consumption within 2 weeks before baseline visit
- Unable to abstain from alcohol during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 weeks
Participants receive daily oral doses of either fezolinetant or placebo to assess efficacy and safety in reducing vasomotor symptoms.
Weekly visits for up to 4 weeks
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
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Research Team
E
Elizabeth Borwick
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study.
Samuel Lederman, Faith D Ottery, Antonio Cano...
https://pubmed.ncbi.nlm.nih.gov/36924778Menopause review: Emerging treatments for menopausal symptoms.
Bijal Patel, Waljit S Dhillo
https://pubmed.ncbi.nlm.nih.gov/34965909Lack of an effect of high dose isoflavones in men with prostate cancer undergoing androgen deprivation therapy.
Preetika Sharma, Amy Wisniewski, Milena Braga-Basaria...
https://pubmed.ncbi.nlm.nih.gov/19758646Endocrine complications of androgen-deprivation therapy in men with prostate cancer.
Lindsey K Harle, Marcello Maggio, Sadeka Shahani...
https://pubmed.ncbi.nlm.nih.gov/17099626Vasomotor symptoms in prostate cancer survivors undergoing androgen deprivation therapy.
M S Hunter, E Stefanopoulou
https://pubmed.ncbi.nlm.nih.gov/26673756Cancer statistics, 2023.
Rebecca L Siegel, Kimberly D Miller, Nikita Sandeep Wagle...
https://pubmed.ncbi.nlm.nih.gov/36633525Fezolinetant: First Approval.
Arnold Lee
https://pubmed.ncbi.nlm.nih.gov/37462862Hypertrophy and increased gene expression of neurons containing neurokinin-B and substance-P messenger ribonucleic acids in the hypothalami of postmenopausal women.
N E Rance, W S Young
https://pubmed.ncbi.nlm.nih.gov/1708331Neurokinin 3 Receptor Antagonism: A Novel Treatment for Menopausal Hot Flushes.
Manish Modi, Waljit S Dhillo
https://pubmed.ncbi.nlm.nih.gov/30504731