Hot Flushes Clinical Trial
Official 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
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.
Oestrogen therapy is the most consistently effective treatment used in the US and Europe for
menopausal VMS. Following the safety issues reported in the primary Women's Health Initiative
publications and with continued subject requests for treatment, a challenge to clinicians has
been to identify the lowest effective dose of oestrogen for alleviating menopausal symptoms.
In addition, it is a challenge to develop a safer oestrogen than those currently used.
For this purpose, the minimum effective dose (MED) of E4 has to be defined for the treatment
of menopausal symptoms. The present study is intended to evaluate changes in frequency and in
severity of moderate to severe VMS in order to define the MED.
Subjects will be randomly allocated to either treatment group (2.5 mg E4, 5 mg E4, 10 mg E4,
15 mg E4, or placebo) in a 1:1:1:1:1 ratio. All treatments (E4 or Placebo) 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.
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