CLIMARA 75 PATCH

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

ESTRADIOL (ESTRADIOL HEMIHYDRATE)

Saadav alates:

BAYER INC

ATC kood:

G03CA03

INN (Rahvusvaheline Nimetus):

ESTRADIOL

Annus:

75MCG

Ravimvorm:

PATCH

Koostis:

ESTRADIOL (ESTRADIOL HEMIHYDRATE) 75MCG

Manustamisviis:

TRANSDERMAL

Ühikuid pakis:

4

Retsepti tüüp:

Prescription

Terapeutiline ala:

ESTROGENS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0106457036; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2007-03-08

Toote omadused

17β)
·
·
·
·
·
·
·
·
·
·
·
·
·
·
=
·
·
·
·
·
·
·
·
·
·
·
·
–
≥
–
≥
–
≥
*
John’s wort.
·
·
·
·
·
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 •
–
–
–
–
–
–
–
–
–
–
–
–
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.
–
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
–
–
–
–
–
–
Patient’s Assessment
Investigator’s Assessment
Patient’s Assessment
Investigator’s Assessment
–
–
–
†
†
†
†
†
†
†
†
†
†
†
†
†
†
†
†
†
†
†
†
<0.0001‡
<0.0001 ‡
0.0001 ‡
<0.0001‡
<0.0001 ‡
†
‡ p < 0.05
17β per day) is not approved for sale in Canada.
–
†
†
†
†
†
†
†
†
†
†
–
†
†
†
†
†
†
†
†
†
†
0.0141 ‡
<0.0001 ‡
0.0001 ‡
<0.0001 ‡
<0.0001 ‡
†
‡ p < 0.05
17β per day) is not approved for sale in Canada.
–
crease in bone mineral density at the hip (trochanteric region,
Ward’s triangle, femoral neck) and spine
Ward’s Triang