CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 356 enrolled
Drug / intervention
Fezolinetant +1 moredrug
Likely dose
Not stated in record
Key inclusion· 9
  • ✓Postmenopausal women aged >40 to ≤65 years
  • ✓BMI 18–38 kg/m²
  • ✓Confirmed menopause: spontaneous amenorrhea ≥12 months, or ≥6 months with FSH >40 IU/L, or bilateral oophorectomy ≥6 weeks prior
  • ✓At least 50 moderate-to-severe vasomotor symptoms per week, documented in daily diary during screening
Key exclusion· 12
  • ✕Current or recent use of prohibited therapies: hormone therapy, hormonal contraceptives, or vasomotor symptom medications (prescription, OTC, or herbal); unwilling to wash out
  • ✕History of drug or alcohol abuse in the past year or active abuse
  • ✕Prior or current malignancy except basal cell carcinoma
  • ✕Uncontrolled hypertension: systolic ≥140 mmHg and/or diastolic ≥90 mmHg

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03192176
NCT03192176Phase 2Completed
CompareCT.gov

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)

Astellas Pharma Global Development, Inc.·interventional·Posted Jun 19, 2017·Updated Nov 26, 2024

In Brief

A Phase 2 clinical trial evaluating Fezolinetant and Placebo for Menopause and Hot Flashes. Completed, enrolled 356 participants across 51 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause, Hot Flashes
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 19, 2017
Enrollment StartJul 19, 2017
Primary CompletionSep 19, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.0 years ago

Interventions

Fezolinetantdrug

Oral Capsule

Placebodrug

Oral Capsule