A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)

Sponsor
Chinese University of Hong Kong
Study ID
NCT07568236
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fezolinetant — DRUG
    Fezolinetant 45 mg orally once daily for 12 weeks.
  • Placebo — DRUG
    Placebo orally once daily for 12 weeks.

Study Details

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.

Key Dates

First listed
May 5, 2026
Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Fezolinetant 45 mg orally once daily for 12 weeks.
  • Placebo Comparator: Placebo Arm
    Placebo orally once daily for 12 weeks.

Primary Outcome Measure

Hot flush severity [ Time Frame: Baseline, week 3, week 7 and week 11 ]

Central Contacts

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