A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorChinese University of Hong Kong
About this trial
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to investigates the efficacy of fezolinetant in men undergoing ADT for prostate cancer in alleviating Vasomotor syndromes.
Eligibility criteria
Qualifiers
Patients aged at least 18 years old on the index date
Histologically confirmed prostatic adenocarcinoma with localised or metastatic disease
Karnofsky index score of 70% or more
Started on androgen deprivation therapy (both medical or surgical), for at least 3 months at baseline
Disqualifiers
Patients treated with drugs related to the study medications or with potential effect for vasomotor symptoms, including selective serotonin-re-uptake inhibitors, steroid hormones, clonidine, gabapentin, veralipride, or β-alanine
Concomitant use of CYP1A2 inhibitors, e.g. fluoroquinolone, fluovoxamine, cimetidine, propranolol, verapamil, acyclovir, allopurinol, theophylline, etc.
Severe (eGFR 15 to less than 30 mL/min/1.73 m2) renal impairment or end-stage renal disease (eGFR less than 15 mL/min/1.73 m2)
Trial design
Treatments tested in this trial
- Fezolinetant
- Placebo
Treatment groups
54 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov