NCT05419908

Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes

Pilot/Phase IIa Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Ogeda S.A. · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study was to evaluate the effect of ESN364 on the severity and frequency of hot flashes in early postmenopausal women suffering from hot flashes, in terms of changes in weekly Hot Flash Score from baseline to Week 12. This study also evaluated the effect of ESN364 on the severity and frequency of hot flashes at additional timepoints; hot flash interference on daily life, in terms of changes from baseline over time in Hot Flash Related Daily Interference Scale (HFRDIS); the effect of ESN364 on climacteric symptoms, in terms of changes from baseline over time in Leeds Sleep Evaluation Questionnaire (LSEQ), Greene Climacteric Scale (GCS), and Sheehan Disability Scale (SDS); pharmacodynamic (PD) effect; and safety and tolerability.

Conditions

• Hot Flashes

Interventions

Type	Name	Description
DRUG	Fezolinetant	Oral Capsule
DRUG	Placebo	Oral Capsule

Timeline

• Start date: 2015-09-21
• Primary completion: 2016-09-21
• Completion: 2016-10-06
• First posted: 2022-06-15
• Last updated: 2024-11-27
• Results posted: 2023-07-25

Locations

8 sites across 1 country: Belgium

Regulatory

• FDA-regulated drug study