NCT03192176

A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)

A Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging, Phase 2b Study to Investigate the Efficacy of ESN364 in Postmenopausal Women Suffering From Vasomotor Symptoms (Hot Flashes)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes. The treatment was administered for 12 weeks to postmenopausal women, aged 40 to 65, suffering at least 50 moderate to severe hot flashes per week.

Detailed description

This was a 12-week randomized, double-blind, placebo-controlled, dose-ranging, parallel-group, multi-center study to assess the efficacy of ESN364 in postmenopausal women suffering from vasomotor symptoms (hot flashes). This study consisted of a screening period (Days -35 to -1, including the screening visit \[Visit 1\] and a minimum 7-day collection of baseline vasomotor symptom frequency and severity assessments), a 12 week treatment period (Day 1 \[Visit 2\] to Week 12 \[Visit 5\]), and a follow up visit (Week 15 \[Visit 6\]) 3 weeks after the last dose of study drug. The study was performed on an ambulatory basis. The screening visit (Visit 1) occurred up to 35 days prior to randomization. Eligibility was assessed via physical examination, clinical laboratory testing, vital signs, ECG, Pap smear, mammography, and endometrial biopsy. Subjects received an electronic diary to record daily vasomotor symptoms during the duration of the screening period. Subjects who had ≥7 consecutive days of vasomotor symptom recordings participated in the study. Subjects are encouraged to continue recording for the duration of the whole screening period. The electronic diary was reviewed by study site staff on Day 1 (Visit 2) to confirm study eligibility. Subjects were rescreened 1 time upon approval of the medical monitor. During the treatment period, subjects returned to the study site every 4 weeks for assessments. The follow-up visit occurred approximately 3 weeks following the last dose of study drug.

Conditions

• Menopause
• Hot Flashes

Interventions

Type	Name	Description
DRUG	Fezolinetant	Oral Capsule
DRUG	Placebo	Oral Capsule

Timeline

• Start date: 2017-07-19
• Primary completion: 2018-09-19
• Completion: 2018-09-19
• First posted: 2017-06-19
• Last updated: 2024-11-26
• Results posted: 2021-09-29

Locations

51 sites across 1 country: United States

Regulatory

• FDA-regulated drug study