CLIMARA 50 PATCH

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ESTRADIOL (ESTRADIOL HEMIHYDRATE)

Disponibil de la:

BAYER INC

Codul ATC:

G03CA03

INN (nume internaţional):

ESTRADIOL

Dozare:

50MCG

Forma farmaceutică:

PATCH

Compoziție:

ESTRADIOL (ESTRADIOL HEMIHYDRATE) 50MCG

Calea de administrare:

TRANSDERMAL

Unități în pachet:

4

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ESTROGENS

Rezumat produs:

Active ingredient group (AIG) number: 0106457035; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2007-03-08

Caracteristicilor produsului

17β)
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John’s wort.
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17β. Upon application to
17β, the major estrogenic hormone secreted by the human ovary.
17β is the predominant estrogen produced by the ovaries in
premenopausal women.
17β), and provides controlled delivery of estradiol
17β,
17β), and provides controlled delivery of estradiol
17β, 0.05
17β), and provides controlled delivery of estradiol
17β,
17β)
PART II: SCIENTIFIC INFORMATION
β
2 •
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17β per day) is not approved for
completed the study. Both CLIMARA 50 and CLIMARA 100 were
significantly (p ≤ 0.05) more
efficacy parameters. Statistically significant (p ≤ 0.05) treatment
effects with both doses were
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change from baseline significantly (p≤0.05) less for placebo group
than for the CLIMARA 50 and CLIMARA 100
Mean score significantly (p≤0.05) less for the placebo group than
for the CLIMARA 50 and CLIMARA 100
CLIMARA 50 and CLIMARA 100 statistically significant at p ≤ 0.05.
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Mean score significantly (p ≤ 0.05) less for the for the CLIMARA 50
group than for the CLIMARA 100
Mean score significantly (p ≤ 0.05) less for the for the CLIMARA 50
group than for the CLIMARA 100 group, and, mean score
significantly (p ≤ 10.05) less for the
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Patient’s Assessment
Investigator’s Assessment
Patient’s Assessment
Investigator’s Assessment
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<0.0001‡
<0.0001 ‡
0.0001 ‡
<0.0001‡
<0.0001 ‡
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‡ p < 0.05
17β per day) is not approved for sale in Canada.
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0.0141 ‡
<0.0001 ‡
0.0001 ‡
<0.0001 ‡
<0.0001 ‡
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‡ p < 0.05
17β per day) is not approved for sale in Canada.
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crease in bone mineral density at the hip (trochanteric region,
Ward’s triangle, femoral neck) and spine
Ward’s Triang