Efficacy & Safety
Efficacy & Safety

Efficacy

Premarin Vaginal Cream 0.5 g twice weekly was shown to reduce moderate to severe dyspareunia due to menopause1

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Just 0.5 g twice weekly is proven to help rebuild vaginal tissue to near premenopausal levels2,3

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Significant reduction in average vaginal pH from baseline at week 12 vs placebo1,2

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Study Description

Results from a 12-week, randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of Premarin Vaginal Cream for the treatment of vulvovaginal atrophy in generally healthy postmenopausal women aged 44 to 77 years (N=423), who at baseline had ≤5% superficial cells on a vaginal smear, a vaginal pH ≥5.0, and who identified a most bothersome moderate to severe symptom of vulvar and vaginal atrophy. Premarin Vaginal Cream was administered using 2 dosing regimens: 0.5 g twice weekly and 0.5 g once daily (21 days on/7 days off). The study consisted of an initial 12-week trial followed by an open-label extension to assess endometrial safety through week 52.

Primary end points were the changes from baseline in vaginal maturation index, vaginal pH, and severity of patient-reported most bothersome symptom at week 12. Participants defined the severity of their most bothersome symptom on the following scale: 1=mild, 2=moderate, 3=severe. For most women, dyspareunia was identified as the most bothersome symptom at baseline. Weekly severity score is an average of the daily scores.1,2


References:
  1. Premarin Vaginal Cream [prescribing information]. New York, NY: Pfizer Inc.; 2018.
  2. Data on file. Pfizer Inc., New York, NY.
  3. Reimer A, Johnson L. Atrophic vaginitis: signs, symptoms, and better outcomes. Nurse Pract. 2011;36(1):22-28.
  4. Freedman MA. Vaginal pH, estrogen and genital atrophy. Menopause Manage. 2008;17:9-13.
Terms and Conditions

By using this Pay As Little As $35 Savings Card, you acknowledge that you currently meet the eligibility criteria and will comply with the Terms and Conditions below:


  • Patients are not eligible to use this Card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicaid, Medicare, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
  • Patient must have private insurance. Offer is not valid for cash-paying patients. The value of this Savings Card is limited to $150 per use or the amount of your co-pay, whichever is less. Limit 2 offers per calendar year. Maximum savings of $300 per calendar year.
  • This Savings Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs.
  • You must deduct the value of this Savings Card from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
  • You are responsible for reporting use of the Savings Card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Savings Card, as may be required. You should not use the Savings Card if your insurer or health plan prohibits use of manufacturer Savings Cards.
  • You must be 18 years of age or older to redeem the Savings Card.
  • This Savings Card is not valid where prohibited by law.
  • Savings Card cannot be combined with any other savings, free trial, or similar offer for the specified prescription.
  • Savings Card will be accepted only at participating pharmacies.
  • This Savings Card is not health insurance.
  • Offer good only in the U.S. and Puerto Rico.
  • Savings card is limited to 1 per person during this offering period and is not transferable.
  • No other purchase is necessary.
  • Data related to your redemption of the Savings Card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Savings Card redemptions and will not identify you.
  • Pfizer reserves the right to rescind, revoke, or amend this offer without notice.
  • Offer expires 12/31/2022.​​​​​​​
For reimbursement when using a nonparticipating pharmacy or a mail-order service:
​​​​​​​
​​​​​​​
  • Pay for PREMARIN® (conjugated estrogens) Vaginal Cream as you normally would.
  • Mail a copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount paid circled to:

    PREMARIN Vaginal Cream Savings Card
    2250 Perimeter Park Drive, Suite 300
    Morrisville, NC 27560​​​​​​​

Be sure to include a copy of the front of your Savings Card, your name, and your mailing address.​​​​​

Visit PremarinVaginalCream.com for more information about PREMARIN Vaginal Cream. For help with the Savings Card, call 1-866-879-4600 or write to: PREMARIN Vaginal Cream Savings Card, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. Be sure to include your name and mailing address.

Efficacy & Safety

  • Efficacy
  • Safety Profile

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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 (eg, stroke, myocardial infarction), or a history of these conditions; anaphylactic reaction or angioedema to Premarin Vaginal Cream; liver dysfunction or disease; thrombophilic disorders; pregnancy.

Estrogens increase the risk of gallbladder disease. Discontinue estrogen if 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.

​​​​​​​In a prospective, randomized, placebo-controlled, double-blind study, the most common adverse reactions (≥2%) were headache, pelvic pain, vasodilation, breast pain, leucorrhea, metrorrhagia, vaginitis, and vulvovaginal disorder.

Premarin Vaginal Cream is indicated for the treatment of atrophic vaginitis and kraurosis vulvae; and 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.

Indications

Premarin Vaginal Cream is indicated for the treatment of atrophic vaginitis and kraurosis vulvae; and for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.