Study to select the daily dose of Estetrol for vasomotor symptoms
Research type
Research Study
Full title
A Multicentre Dose-Finding, Randomised, Double-Blind, Placebo-Controlled Study to Select the Daily Oral Dose of Estetrol (E4) for the Treatment of Vasomotor Symptoms in Post-Menopausal Women
IRAS ID
199125
Contact name
Paula Briggs
Contact email
Sponsor organisation
Donesta Bioscience BV
Eudract number
2015-004018-44
Duration of Study in the UK
0 years, 10 months, 26 days
Research summary
The study is for an experimental drug which contains estetrol (E4). E4 is a natural oestrogen only produced during pregnancy by the liver of a developing foetus and reaches the mother’s blood circulation through the placenta.
Based on various studies, E4 may be used for hormone replacement therapy (HRT) to help relieve symptoms of menopause, replacing female hormones that are at a lower level as menopause occurs.
The purpose of this study is to find the lowest possible oral dose of E4 needed to reduce the frequency and severity of menopausal hot flushes while still being safe and tolerable (the influence of the drug on the body).
This is a placebo-controlled, randomised, dose-finding, double-blinded study. Participants will receive either E4 or a placebo, selection will be randomised. There are four different doses of E4 being tested to find the lowest dose. Participants will be randomly assigned to receive either 2.5 mg, or 5 mg, or 10 mg, or 15 mg or placebo. The study is aimed at post-menopausal women aged between 45 to 65 years inclusive.
The expected duration of the study is about 16 weeks. About 225 subjects will be treated by participating in this study. There will be a total of 5 planned study visits, during these visits participants will be expected to undergo a number of tests including blood tests, physical examinations and ultrasound scans. Participants will also be required to maintain an electronic diary at home.REC name
East Midlands - Derby Research Ethics Committee
REC reference
16/EM/0180
Date of REC Opinion
2 Aug 2016
REC opinion
Further Information Favourable Opinion