US Obstetrics & Gynecology 2007 - Issue 1

Ascend_ad.qxp 29/5/07 11:15 am Page 62
?<IGI<=<II<;IFLK<KFI<C@<=F=D<EFG8LJ8CJPDGKFDJ
8?@>?N8PKF><C
=fid\efgXljXcjpdgkfdi\c`\]#
<JKIF><C><KJ?<I98:BFEKI8:B
• al gel applied to the arm once daily
1
• fective relief with a low dose of estradiol
1
• al to the body’s own estrogen
1,2
• n exact dose—1 pump equals 1 dose,
.625 mg alone and during 4 years of treatment with CE
with MPA 2.5 mg, relative to placebo. It is unknown
applies to younger postmenopausal women.
gated estrogens with medroxyprogesterone acetate, and
and dosage forms of estrogens and progestins, were not
HI clinical trials and, in the absence of comparable data, these
sks should be assumed to be similar. Because of these risks, estrogens with
or without progestins should be prescribed at the lowest effective dose and
following conditions: for the shortest duration consistent with treatment goals and risks for the
undiagnosed abnormal genital bleeding; known, suspected, or history of breast individual woman.
cancer; known or suspected estrogen-dependent neoplasia; active deep vein
thrombosis, pulmonary embolism, or history of these conditions; active or
Because of the risk of endometrial cancer, close clinical surveillance of
recent arterial thromboembolic disease; liver dysfunction or disease; known
all women taking estrogens is important. Adequate diagnostic measures,
hypersensitivity to ingredients in EstroGel; known or suspected pregnancy.
including endometrial sampling when indicated, should be undertaken to rule
out malignancy in all cases of undiagnosed persistent or recurring abnormal
Estrogens with or without progestins should not be used for the vaginal bleeding. There is no evidence that the use of “natural” estrogens
prevention of cardiovascular disease. The estrogen-alone substudy of the results in a different endometrial risk profile than synthetic estrogens at
Women’s Health Initiative (WHI) reported increased risks of stroke and deep equivalent estrogen doses.
vein thrombosis (DVT) in postmenopausal women (aged 50-79 years) during
6.8 and 7.1 years, respectively, of treatment with oral conjugated estrogens
In some studies, the use of estrogens and progestins by postmenopausal
(CE 0.625 mg) per day, relative to placebo.
women has been reported to increase the risk of breast cancer.
The estrogen-plus-progestin substudy of the WHI reported increased risks of
Gallbladder disease, hypercalcemia in patients with breast cancer and bone
myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and
metastases, and retinal vascular thrombosis have been reported in patients
deep vein thrombosis in postmenopausal women (aged 50-79 years) during
receiving estrogens.
5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined In clinical studies, the most commonly reported adverse events for EstroGel
with medroxyprogesterone acetate (MPA 2 5 mg) per day relative to placebo were headache infection breast pain vaginitis abdominal pain pain and rash
nnn%\jkif^\c%Zfd
Page 1 | Page 2 | Page 3 | Page 4 | Page 5 | Page 6 | Page 7 | Page 8 | Page 9 | Page 10 | Page 11 | Page 12 | Page 13 | Page 14 | Page 15 | Page 16 | Page 17 | Page 18 | Page 19 | Page 20 | Page 21 | Page 22 | Page 23 | Page 24 | Page 25 | Page 26 | Page 27 | Page 28 | Page 29 | Page 30 | Page 31 | Page 32 | Page 33 | Page 34 | Page 35 | Page 36 | Page 37 | Page 38 | Page 39 | Page 40 | Page 41 | Page 42 | Page 43 | Page 44 | Page 45 | Page 46 | Page 47 | Page 48 | Page 49 | Page 50 | Page 51 | Page 52 | Page 53 | Page 54 | Page 55 | Page 56 | Page 57 | Page 58 | Page 59 | Page 60 | Page 61 | Page 62 | Page 63 | Page 64 | Page 65 | Page 66 | Page 67 | Page 68 | Page 69 | Page 70 | Page 71 | Page 72 | Page 73 | Page 74 | Page 75