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

NCT04209543 PHASE3 COMPLETED

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)

Details

Lead sponsor	Estetra
Phase	PHASE3
Status	COMPLETED
Enrolment	1570
Start date	Mon Dec 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Feb 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Vasomotor Symptoms
• Menopausal Symptoms

Interventions

• Estetrol
• Placebo
• Progesterone

Countries

Italy, Slovakia, Russia, United Kingdom, Hungary, Poland, Argentina, Canada, Lithuania, Romania, Spain, United States, Brazil, Czechia