CLIMARA 25 PATCH

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ESTRADIOL (ESTRADIOL HEMIHYDRATE)

Available from:

BAYER INC

ATC code:

G03CA03

INN (International Name):

ESTRADIOL

Dosage:

25MCG

Pharmaceutical form:

PATCH

Composition:

ESTRADIOL (ESTRADIOL HEMIHYDRATE) 25MCG

Administration route:

TRANSDERMAL

Units in package:

4

Prescription type:

Prescription

Therapeutic area:

ESTROGENS

Product summary:

Active ingredient group (AIG) number: 0106457033; AHFS:

Authorization status:

APPROVED

Authorization date:

2007-03-08

Summary of Product characteristics

17β)
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=
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–
≥
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≥
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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
–
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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–
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†
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<0.0001‡
<0.0001 ‡
0.0001 ‡
<0.0001‡
<0.0001 ‡
†
‡ 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 ‡
†
‡ 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