Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations
NCT ID: NCT00184795
Last Updated: 2017-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
576 participants
INTERVENTIONAL
2004-05-28
2005-05-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ALD 0.1
0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
One tablet per day for 24 weeks
ALD 0.25
0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
One tablet per day for 24 weeks
Placebo
placebo
Placebo tablets for 24 weeks
Interventions
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0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
One tablet per day for 24 weeks
0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
One tablet per day for 24 weeks
placebo
Placebo tablets for 24 weeks
Eligibility Criteria
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Inclusion Criteria
* Subject should have had a minimum of 7 moderate to severe hot flushes per day, or a minimum of 50 moderate to severe hot flushes per week, during the last 2 weeks of the run-in (screening) period.
* Subject with an intact uterus
Exclusion Criteria
* Body Mass Index (BMI) \> 35.0 kg/m2
* Known alcohol or drug abuse, heavy smoking (more than 20 cigarettes a day)
* Currently using steroid hormones (except topical or inhalation glucocorticoid preparations) and drugs known to influence estrogen metabolism such as barbiturates, phenytoin, rifampicin, carbamazepin
45 Years
65 Years
FEMALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
Vienna, , Austria
Novo Nordisk Investigational Site
Brussels, , Belgium
Novo Nordisk Investigational Site
Brussels, , Belgium
Novo Nordisk Investigational Site
Brussels, , Belgium
Novo Nordisk Investigational Site
Ghent, , Belgium
Novo Nordisk Investigational Site
Huy, , Belgium
Novo Nordisk Investigational Site
Leuven, , Belgium
Novo Nordisk Investigational Site
Liège, , Belgium
Novo Nordisk Investigational Site
Montigny-le-Tilleul, , Belgium
Novo Nordisk Investigational Site
Watermael-Boifort, , Belgium
Novo Nordisk Investigational Site
Allerød Municipality, , Denmark
Novo Nordisk Investigational Site
Århus C, , Denmark
Novo Nordisk Investigational Site
Frederiksberg, , Denmark
Novo Nordisk Investigational Site
Hvidovre, , Denmark
Novo Nordisk Investigational Site
København N, , Denmark
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Næstved, , Denmark
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Odense C, , Denmark
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Virum, , Denmark
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Espoo, , Finland
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Helsinki, , Finland
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Oulu, , Finland
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Tampere, , Finland
Novo Nordisk Investigational Site
Turku, , Finland
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Amiens, , France
Novo Nordisk Investigational Site
La Roche-sur-Yon, , France
Novo Nordisk Investigational Site
Marseille, , France
Novo Nordisk Investigational Site
Marseille, , France
Novo Nordisk Investigational Site
Montpellier, , France
Novo Nordisk Investigational Site
Montpellier, , France
Novo Nordisk Investigational Site
Nantes, , France
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Narbonne, , France
Novo Nordisk Investigational Site
Nice, , France
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Nîmes, , France
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Toulouse, , France
Novo Nordisk Investigational Site
Jessen, , Germany
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Karlsruhe, , Germany
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Leipzig, , Germany
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Lorsch, , Germany
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Rheine, , Germany
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Rheinstetten, , Germany
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Schorndorf, , Germany
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Stuttgart, , Germany
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Tübingen, , Germany
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Völklingen, , Germany
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Grålum, , Norway
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Hamar, , Norway
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Kolbotn, , Norway
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Lillestrøm, , Norway
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Oslo, , Norway
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Paradis, , Norway
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Stavanger, , Norway
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Stavanger, , Norway
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Trondheim, , Norway
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Linköping, , Sweden
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Linköping, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Norrköping, , Sweden
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Uppsala, , Sweden
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Bulle, , Switzerland
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Frauenfeld, , Switzerland
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Weinfelden, , Switzerland
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Zurich, , Switzerland
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Zurich, , Switzerland
Novo Nordisk Investigational Site
Aldershot, , United Kingdom
Novo Nordisk Investigational Site
Bexhill-on-Sea, , United Kingdom
Novo Nordisk Investigational Site
Birmingham, , United Kingdom
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Bolton, , United Kingdom
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Chesterfield, Derbyshire, , United Kingdom
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Chippenham, , United Kingdom
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Cornwell, , United Kingdom
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Coventry, , United Kingdom
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Devon, , United Kingdom
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Hastings, , United Kingdom
Novo Nordisk Investigational Site
Hull, , United Kingdom
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Linclolshire, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
Novo Nordisk Investigational Site
London, , United Kingdom
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Manchester, , United Kingdom
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Norfolk, , United Kingdom
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Oxford, , United Kingdom
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Reading, , United Kingdom
Novo Nordisk Investigational Site
Sheffield, , United Kingdom
Novo Nordisk Investigational Site
Stoke-on-Trent, , United Kingdom
Novo Nordisk Investigational Site
Suffolk, , United Kingdom
Novo Nordisk Investigational Site
Watford, , United Kingdom
Countries
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References
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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.
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.
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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2004-000103-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALD-1537
Identifier Type: -
Identifier Source: org_study_id
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