E4Relief (Response to Estetrol in Life Improvement for MEnopausal-associated Hot Flushes)

PHASE2CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

January 22, 2018

Study Completion Date

January 22, 2018

Conditions
Hot Flushes
Interventions
DRUG

Estetrol

All treatments (E4 \[2.5 mg, 5 mg, 10 mg, 15 mg\] capsule) will be administered once daily (QD) per os for at least 12 consecutive weeks until the last biological assessments (Day 90 maximum) have been performed.

DRUG

Placebo

1 capsule will be administered QD per os for at least 12 consecutive weeks until the last biological assessments (Day 90 maximum) have been performed.

Trial Locations (1)

4000

Donesta Bioscience BV, Liège

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

SynteractHCR

INDUSTRY

lead

Donesta Bioscience

INDUSTRY