To demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
391
Site 11
Zagreb, Croatia
Site 12
Zagreb, Croatia
Site 13
Zagreb, Croatia
The change in the number of moderate to severe hot flushes from baseline to week 13
Time frame: 12 weeks
Change in the number of hot flushes from baseline to week 13; Change in the number of hot flushes and moderate to severe hot flushes from baseline to weeks 4 and 8;
Time frame: 12 weeks
Change in the Menopause Rating Scale from baseline to weeks 4 and 13;
Time frame: 52 weeks
Number of days with bleeding/spotting; Number of bleeding/spotting episodes; Number of days with a certain bleeding intensity (e.g. bleeding intensity =2);
Time frame: 52 weeks
Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no;
Time frame: 52 weeks
QualiPause Inventory 7D: weighted sum score of the symptoms
Time frame: 52 weeks
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Site 23
Cannes, France
Site 24
Cannes, France
Site 21
Montpellier, France
Site 22
Montpellier, France
Site 34
Katowice, Poland
Site 33
Krakow, Poland
Site 32
Lódź, Poland
...and 8 more locations