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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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2008-11-30
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Angemin
1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP
Angemin vs Activelle
1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP or 1 mg of oral E2 in continuous combination with 0.5 mg of NETA during six months.
Activelle
1 mg of oral E2 in continuous combination with 0.5 mg of NETA
Angemin vs Activelle
1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP or 1 mg of oral E2 in continuous combination with 0.5 mg of NETA during six months.
Interventions
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Angemin vs Activelle
1 mg of oral oestradiol (E2) in continuous combination with 2 mg of DRSP or 1 mg of oral E2 in continuous combination with 0.5 mg of NETA during six months.
Eligibility Criteria
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Inclusion Criteria
* They should be amenorrheic for at least 12 months or less than 12 months with S- FSH values \>40 IU/L.
* They should be free of any sex hormone treatment for at least three months before inclusion.
Exclusion Criteria
* Any previous history of cancer.
* Any previous history of breast disease or abnormal mammogram.
* In addition: hypertension (systolic BP \>160 mm Hg or diastolic \>100 mm Hg), hyperlipidemia (total cholesterol \>8.0 mmol/L or triglycerides \>3.0 mmol/L), diabetes mellitus, history of thromboembolic disease, heart failure, liver disease or porphyria, undiagnosed vaginal bleeding. No sex hormone treatment for at least three months before inclusion.
* No concomitant treatment known to influence hormone metabolism (warfarin, rifampicin, carbamazepine, griseofulvin, hydantoins, primidone, barbiturates, broad spectrum antibiotics) is to be accepted.
50 Years
60 Years
FEMALE
Yes
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Karolinska University Hospital
Locations
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Karolinska University Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Other Identifiers
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080818
Identifier Type: -
Identifier Source: org_study_id