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INDICATION Premarin® (conjugated estrogens) Vaginal Cream is indicated for the
treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal
atrophy, due to menopause.
Important Safety Information

There is an increased risk of endometrial cancer in a woman with a uterus who
uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown
to reduce the risk of endometrial hyperplasia, which may be a precursor to
endometrial cancer. Adequate diagnostic measures, including directed or random
endometrial sampling when indicated, should be undertaken to rule out malignancy
in postmenopausal women with undiagnosed persistent or recurring abnormal
genital bleeding.

Estrogens with or without progestins should not be used for the prevention of
cardiovascular disease or dementia.

The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased
risks of stroke and deep vein thrombosis (DVT) in postmenopausal women with
daily oral conjugated estrogens (CE) alone. The WHI estrogen plus progestin
substudy reported increased risks of DVT, pulmonary embolism, stroke, and
myocardial infarction in postmenopausal women with daily oral CE combined with
medroxyprogesterone acetate (MPA). In the absence of comparable data, these
risks should be assumed to be similar for other dosage forms of estrogens.

The WHI Memory Study (WHIMS) reported an increased risk of developing probable
dementia in postmenopausal women 65 years of age or older, in both the estrogen
alone and estrogen plus progestin arms. It is unknown whether these findings
apply to younger postmenopausal women.

The WHI estrogen plus progestin substudy demonstrated an increased risk of
invasive breast cancer.

Estrogens with or without progestins should be prescribed at the lowest
effective dose and for the shortest duration consistent with treatment goals and
risks for the individual woman.

Premarin Vaginal Cream should not be used in women with any of the following
conditions: undiagnosed abnormal genital bleeding; known, suspected, or a
history of breast cancer; known or suspected estrogen-dependent neoplasia;
active deep vein thrombosis, pulmonary embolism, or a history of these
conditions; active arterial thromboembolic disease (e.g., stroke, myocardial
infarction), or a history of these conditions; anaphylactic reaction or
angioedema with Premarin Vaginal Cream; liver dysfunction or disease;
thrombophilic disorders; pregnancy.

The WHI estrogen plus progestin sub-study reported a statistically
non-significant increased risk of ovarian cancer. A meta-analysis of 17
prospective and 35 retrospective epidemiology studies found that women who used
hormonal therapy for menopausal symptoms had an increased risk for ovarian
cancer. The exact duration of hormone therapy use associated with an increased
risk of ovarian cancer, however, is unknown.

Estrogens increase the risk of gallbladder disease. Discontinue estrogen if
severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic
jaundice occurs. Monitor thyroid function in women on thyroid replacement
therapy, because estrogens may be associated with increased thyroid binding
globulin (TBG) levels.

The most common adverse reactions (≥2%) were headache, pelvic pain,
vasodilation, breast pain, leucorrhea, metrorrhagia, vaginitis, and vulvovaginal
disorder.

Indication Premarin Vaginal Cream is indicated for the treatment of moderate to
severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

Please see full Prescribing Information, including BOXED WARNING and Patient
Information.

In a prespecified secondary endpoint,

Overall vaginal health was assessed at baseline and week 122

 * Total composite scores‡ increased with Premarin Vaginal Cream from 10.78 to
   16.31 (n=139) vs 10.09 to 11.76 with placebo (n=68)
   
   - A total score of ≤15 is consistent with moderate to severe vaginal atrophy 

 

Overall vaginal health was a total composite score of:

 * Moisture
 * Epithelial mucosa
 * Fluid secretion
 * Vaginal rugosity
 * Vaginal pH
 * Mucosa color 

No conclusions can be made regarding significance or the individual components
comprising the total composite score.
 

‡Genital Health Clinical Evaluation is a tool used to measure overall vaginal
health by using a total composite score of the parameters listed above.
Individual components were not analyzed separately. 

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