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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-00215-25 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
| |
| C | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous combined estradiol and dydrogesterone | Drug | 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the number of moderate to severe hot flushes from baseline to week 13 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | 12 weeks | |
| Change in the Menopause Rating Scale from baseline to weeks 4 and 13; | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 11 | Zagreb | Croatia | ||||
| Site 12 |
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| continuous combined estradiol and dydrogesterone |
| Drug |
1 Mg Estradiol and 5 Mg Dydrogesterone |
|
| Placebo | Drug | Placebo |
|
| 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; | 52 weeks |
| QualiPause Inventory 7D: weighted sum score of the symptoms | 52 weeks |
| Zagreb |
| Croatia |
| Site 13 | Zagreb | Croatia |
| 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 |
| Site 31 | Warsaw | Poland |
| Site 41 | Bucharest | Romania |
| Site 42 | Bucharest | Romania |
| Site 44 | Bucharest | Romania |
| Site 43 | Craiova, Jud.Dolj | Romania |
| Site 51 | Moscow | Russia |
| Site 52 | Moscow | Russia |
| Site 53 | Moscow | Russia |
| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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