NCT04209543

Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)

A Randomized Double-blind Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study I)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,570 (actual)
• Sponsor: Estetra · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a two-part study designed to evaluate the effect of Estetrol (E4) 15 or 20 mg, or placebo on the severity and frequency of vasomotor symptoms (VMS) (Efficacy Study Part) and the safety of E4 20 mg (Endometrial and General Safety Study Part)

Detailed description

This study consists of two-parts, performed with 2 separate groups of participants: • Efficacy Study Part: Designed to evaluate the frequency and severity of vasomotor symptoms \[VMS\] in both hysterectomized and non-hysterectomized postmenopausal participants after treatment with E4 15 mg or 20 mg or placebo for up to 13 consecutive weeks. For endometrial protection, all non-hysterectomized participants were treated with 200 mg progesterone (P4) once daily for 14 consecutive days, after completion of the E4/placebo treatment. This part of the study consisted of 3 treatment groups. • Safety Study Part: The Endometrial and General Safety Study Part is designed to evaluate the general safety, endometrial safety, secondary efficacy (lipid, glucose metabolism, health-related quality of life (HRQoL) and treatment satisfaction) of E4 in non-hysterectomized participants. All participants received E4 20 mg in combination with 100 mg P4 continuously for up to 53 weeks.

Conditions

• Vasomotor Symptoms
• Menopausal Symptoms

Interventions

Type	Name	Description
DRUG	Estetrol	Estetrol oral tablet: administered orally once daily
DRUG	Placebo	Placebo oral tablet: administered orally once daily
DRUG	Progesterone	Progesterone oral tablet: administered orally once daily

Timeline

• Start date: 2019-12-30
• Primary completion: 2024-02-08
• Completion: 2024-02-08
• First posted: 2019-12-24
• Last updated: 2025-01-29

Locations

224 sites across 14 countries: United States, Argentina, Brazil, Canada, Czechia, Hungary, Italy, Lithuania, Poland, Romania, Russia, Slovakia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study