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

NCT02834312 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2024-11-18

No results posted yet for this study

Summary

This dose-finding study is being conducted to select the daily oral dose of estetrol (E4) for the treatment of vasomotor symptoms (VMS) in post-menopausal women.

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.

Sponsors & Collaborators

  • SynteractHCR

    collaborator INDUSTRY

  • Donesta Bioscience

    lead INDUSTRY

Principal Investigators

  • Donesta Bioscience · Donesta Bioscience BV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-01-22
Completion
2018-01-22

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02834312 on ClinicalTrials.gov