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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000103-17 | EudraCT Number |
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This trial is conducted in Europe. Postmenopausal women with moderate to severe hot flashes have been recruited into the trial. The earliest effect of ultra low dose HRT (hormone replacement therapy) on frequency and severity of menopausal symptoms, bleeding patterns and safety of different hormonal combinations will be evaluated and compared to placebo over the six month treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALD 0.1 | Experimental |
| |
| ALD 0.25 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA) | Drug | One tablet per day for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean number of moderate to severe hot flushes per week | At week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Urogenital symptoms | Week 0; week 24 | |
| Vaginal cytology and pH | Week 0; week 24 | |
| Bleeding profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Vienna | A 1060 | Austria | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18202966 | Result | Sturdee DW, Archer DF, Rakov V, Lang E; CHOICE Study Investigators. Ultra-low-dose continuous combined estradiol and norethisterone acetate: improved bleeding profile in postmenopausal women. Climacteric. 2008 Feb;11(1):63-73. doi: 10.1080/13697130701852390. | |
| 17487652 | Result | Lundstrom E, Bygdeson M, Svane G, Azavedo E, von Schoultz B. Neutral effect of ultra-low-dose continuous combined estradiol and norethisterone acetate on mammographic breast density. Climacteric. 2007 Jun;10(3):249-56. doi: 10.1080/13697130701385805. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA) |
| Drug |
One tablet per day for 24 weeks |
|
| placebo | Drug | Placebo tablets for 24 weeks |
|
| Week 0; week 24 |
| Adverse Events | Week 0; week 24 |
| Menopausal symptoms and quality of life (Greene Climacteric Scale) | Week 0; week 24 |
| Hot flush weekly weighted score | Week 0; week 24 |
| Vienna |
| A 1090 |
| Austria |
| Novo Nordisk Investigational Site | Brussels | 1000 | Belgium |
| Novo Nordisk Investigational Site | Brussels | 1180 | Belgium |
| Novo Nordisk Investigational Site | Brussels | 1200 | Belgium |
| Novo Nordisk Investigational Site | Ghent | 9000 | Belgium |
| Novo Nordisk Investigational Site | Huy | 4500 | Belgium |
| Novo Nordisk Investigational Site | Leuven | 3000 | Belgium |
| Novo Nordisk Investigational Site | Liège | 4000 | Belgium |
| Novo Nordisk Investigational Site | Montigny-le-Tilleul | 6110 | Belgium |
| Novo Nordisk Investigational Site | Watermael-Boifort | 1170 | Belgium |
| Novo Nordisk Investigational Site | Allerød Municipality | 3450 | Denmark |
| Novo Nordisk Investigational Site | Århus C | 8000 | Denmark |
| Novo Nordisk Investigational Site | Frederiksberg | 2000 | Denmark |
| Novo Nordisk Investigational Site | Hvidovre | 2650 | Denmark |
| Novo Nordisk Investigational Site | København N | 2400 | Denmark |
| Novo Nordisk Investigational Site | Næstved | 4700 | Denmark |
| Novo Nordisk Investigational Site | Odense C | 5000 | Denmark |
| Novo Nordisk Investigational Site | Virum | 2830 | Denmark |
| Novo Nordisk Investigational Site | Espoo | 02200 | Finland |
| Novo Nordisk Investigational Site | Helsinki | 00100 | Finland |
| Novo Nordisk Investigational Site | Oulu | 90100 | Finland |
| Novo Nordisk Investigational Site | Tampere | 33101 | Finland |
| Novo Nordisk Investigational Site | Turku | 20100 | Finland |
| Novo Nordisk Investigational Site | Amiens | France |
| Novo Nordisk Investigational Site | La Roche-sur-Yon | 85295 | France |
| Novo Nordisk Investigational Site | Marseille | 13004 | France |
| Novo Nordisk Investigational Site | Marseille | 13385 | France |
| Novo Nordisk Investigational Site | Montpellier | 34000 | France |
| Novo Nordisk Investigational Site | Montpellier | 34295 | France |
| Novo Nordisk Investigational Site | Nantes | 44093 | France |
| Novo Nordisk Investigational Site | Narbonne | 11108 | France |
| Novo Nordisk Investigational Site | Nice | 06000 | France |
| Novo Nordisk Investigational Site | Nîmes | 30000 | France |
| Novo Nordisk Investigational Site | Toulouse | 31059 | France |
| Novo Nordisk Investigational Site | Jessen | 06917 | Germany |
| Novo Nordisk Investigational Site | Karlsruhe | 76199 | Germany |
| Novo Nordisk Investigational Site | Leipzig | 04207 | Germany |
| Novo Nordisk Investigational Site | Lorsch | 64653 | Germany |
| Novo Nordisk Investigational Site | Rheine | 48431 | Germany |
| Novo Nordisk Investigational Site | Rheinstetten | 76287 | Germany |
| Novo Nordisk Investigational Site | Schorndorf | 73614 | Germany |
| Novo Nordisk Investigational Site | Stuttgart | 70563 | Germany |
| Novo Nordisk Investigational Site | Tübingen | 72076 | Germany |
| Novo Nordisk Investigational Site | Völklingen | 66333 | Germany |
| Novo Nordisk Investigational Site | Grålum | 1713 | Norway |
| Novo Nordisk Investigational Site | Hamar | NO-2317 | Norway |
| Novo Nordisk Investigational Site | Kolbotn | 1410 | Norway |
| Novo Nordisk Investigational Site | Lillestrøm | 2000 | Norway |
| Novo Nordisk Investigational Site | Oslo | 0309 | Norway |
| Novo Nordisk Investigational Site | Paradis | 5231 | Norway |
| Novo Nordisk Investigational Site | Stavanger | 4088 | Norway |
| Novo Nordisk Investigational Site | Stavanger | NO-4011 | Norway |
| Novo Nordisk Investigational Site | Trondheim | NO-7012 | Norway |
| Novo Nordisk Investigational Site | Gothenburg | 411 19 | Sweden |
| Novo Nordisk Investigational Site | Gothenburg | 416 85 | Sweden |
| Novo Nordisk Investigational Site | Linköping | 581 85 | Sweden |
| Novo Nordisk Investigational Site | Linköping | 582 22 | Sweden |
| Novo Nordisk Investigational Site | Lund | 221 85 | Sweden |
| Novo Nordisk Investigational Site | Malmö | 217 44 | Sweden |
| Novo Nordisk Investigational Site | Norrköping | 602 32 | Sweden |
| Novo Nordisk Investigational Site | Uppsala | 751 85 | Sweden |
| Novo Nordisk Investigational Site | Bulle | 1630 | Switzerland |
| Novo Nordisk Investigational Site | Frauenfeld | 8500 | Switzerland |
| Novo Nordisk Investigational Site | Weinfelden | 8570 | Switzerland |
| Novo Nordisk Investigational Site | Zurich | 8032 | Switzerland |
| Novo Nordisk Investigational Site | Zurich | 8091 | Switzerland |
| Novo Nordisk Investigational Site | Aldershot | GU12 5BA | United Kingdom |
| Novo Nordisk Investigational Site | Bexhill-on-Sea | TN39 4SP | United Kingdom |
| Novo Nordisk Investigational Site | Birmingham | BE9'1 2JL | United Kingdom |
| Novo Nordisk Investigational Site | Bolton | BL1 6AF | United Kingdom |
| Novo Nordisk Investigational Site | Chesterfield, Derbyshire | S40 4AA | United Kingdom |
| Novo Nordisk Investigational Site | Chippenham | SN15 1HP | United Kingdom |
| Novo Nordisk Investigational Site | Cornwell | TR1 2LZ | United Kingdom |
| Novo Nordisk Investigational Site | Coventry | CV6 2FL | United Kingdom |
| Novo Nordisk Investigational Site | Devon | BH15 2JB | United Kingdom |
| Novo Nordisk Investigational Site | Hastings | TN34 3EY | United Kingdom |
| Novo Nordisk Investigational Site | Hull | HU2 8PX | United Kingdom |
| Novo Nordisk Investigational Site | Linclolshire | PE21 6PF | United Kingdom |
| Novo Nordisk Investigational Site | Liverpool | L8 7SS | United Kingdom |
| Novo Nordisk Investigational Site | London | SE1 9RT | United Kingdom |
| Novo Nordisk Investigational Site | London | SE5 8RS | United Kingdom |
| Novo Nordisk Investigational Site | London | W12 0HS | United Kingdom |
| Novo Nordisk Investigational Site | Manchester | M13 0JH | United Kingdom |
| Novo Nordisk Investigational Site | Norfolk | NR4 7UZ | United Kingdom |
| Novo Nordisk Investigational Site | Oxford | OX3 9UD | United Kingdom |
| Novo Nordisk Investigational Site | Reading | RG7 3SQ | United Kingdom |
| Novo Nordisk Investigational Site | Sheffield | S1 2PJ | United Kingdom |
| Novo Nordisk Investigational Site | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Novo Nordisk Investigational Site | Suffolk | IP33 1HE | United Kingdom |
| Novo Nordisk Investigational Site | Watford | HA1 3UJ | United Kingdom |
| 17453860 | Result | Panay N, Ylikorkala O, Archer DF, Gut R, Lang E. Ultra-low-dose estradiol and norethisterone acetate: effective menopausal symptom relief. Climacteric. 2007 Apr;10(2):120-31. doi: 10.1080/13697130701298107. |
| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| D000077563 | Norethindrone Acetate |
| 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 |
| D009640 | Norethindrone |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
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