Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000227-15 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone | Drug | p.o. daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of endometrial hyperplasia or a more serious endometrial outcome during the 52 week treatment period | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days with bleeding/spotting; Number of bleeding/spotting episodes; Number of days with a certain bleeding intensity (e.g. bleeding intensity =2); | 52 weeks | |
| Length of bleeding free intervals; Amenorrhoea yes/no (absence of spotting and bleeding); Absence of bleeding yes/no; |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 10 | Zagreb | Croatia | ||||
| Site 11 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 52 weeks |
| Zagreb |
| Croatia |
| Site 12 | Zagreb | Croatia |
| 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 |
| Site 33 | Warsaw | Poland |
| Site 40 | Bucharest | Romania |
| Site 41 | Bucharest | Romania |
| Site 42 | Bucharest | Romania |
| Site 43 | Bucharest | Romania |
| Site 44 | Bucharest | Romania |
| Site 45 | Bucharest | Romania |
| Site 24 | Donetsk | Ukraine |
| Site 20 | Kiev | Ukraine |
| Site 21 | Kiev | Ukraine |
| Site 22 | Kiev | Ukraine |
| Site 23 | Zaporizhzhya | Ukraine |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004394 | Dydrogesterone |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
Not provided
Not provided