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 — DRUGFezolinetant 45 mg orally once daily for 12 weeks.
- Placebo — DRUGPlacebo 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 ArmFezolinetant 45 mg orally once daily for 12 weeks.
- Placebo Comparator: Placebo ArmPlacebo orally once daily for 12 weeks.
Primary Outcome Measure
Hot flush severity [ Time Frame: Baseline, week 3, week 7 and week 11 ]
Central Contacts
- Alex LIU, RCSEd, MBBS35052625
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