The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
454
p.o. daily
Site 10
Zagreb, Croatia
Site 11
Zagreb, Croatia
Site 12
Zagreb, Croatia
Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period
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 (domains: psychological, vasomotor, somatic, sexual, menstrual, androgenic): average score of the single items within the domain; QualiPause Inventory 7D: weighted sum score of the symptoms
Time frame: 52 weeks
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Site 13
Zagreb, Croatia
Site 32
Katowice, Poland
Site 30
Krakow, Poland
Site 35
Krakow, Poland
Site 36
Krakow, Poland
Site 34
Lublin, Poland
Site 31
Miechów, Poland
...and 12 more locations