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Prescribing Information, including BOXED WARNINGPatient InformationIndicationPatient Site
Efficacy At week 12 in a clinical trial, Premarin Vaginal Cream was clinically proven to make moderate to severe painful sex due to menopause more comfortable at just 0.5 g twice weekly1

P<.001 Premarin Vaginal Cream vs placebo.

†Severity score: 1=mild, 2=moderate, 3=severe.2 

Click for Secondary Endpoint

P<.001 Premarin Vaginal Cream vs placebo.

Placebo cream 0.5 g twice weekly (n=68) increased superficial cells from 0.5% to 2.0% and decreased parabasal cells from 63.9% to 54.8% after 12 weeks of treatment.2

ReferencesVMI, Vaginal Maturation Index. This image is for illustrative purposes only. Individual results may vary.
Scroll left to view table
Premarin Vaginal Cream is proven to help rebuild vaginal tissue to near premenopausal levels2,3§
References§Higher percentages of superficial cells and lower percentages of parabasal cells indicate improvement in VMI.2 Before menopause, a woman’s vaginal epithelium has an average of 30% to 60% superficial cells and 0% parabasal cells.3

Placebo cream 0.5 g twice weekly (n=64) reduced vaginal pH from 6.7 at baseline to 6.4 at week 12.2

P<.001 Premarin Vaginal Cream vs placebo.

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. 

Study Description

Results from a 12-week, randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of Premarin Vaginal Cream 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:

Premarin Vaginal Cream. Prescribing information. Pfizer; 2024.

Data on file. Pfizer Inc., New York, NY.Reimer A, Johnson L. Atrophic vaginitis: signs, symptoms, and better outcomes. Nurse Pract. 2011;36(1):22-28.Freedman MA. Vaginal pH, estrogen and genital atrophy. Menopause Manage. 2008;17:9-13.

Terms and Conditions

By using this Premarin Vaginal Cream Co-Pay Card you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described 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 Medicare, Medicaid, TRICARE, Veteran 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 Co-Pay Card is limited to $150 per use or the amount of your co-pay, whichever is less.
  • Maximum savings of $300 per calendar year.
  • This Co-Pay 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 Co-Pay 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 Co-Pay Card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the [coupon/co-pay card], as may be required. You should not use the Co-Pay Card if your insurer or health plan prohibits use of manufacturer co-pay cards.
  • You must be 18 years of age or older to redeem the Co-Pay Card.
  • This Co-Pay Card is not valid where prohibited by law.
  • The benefit under the Co-Pay Card program is offered to, and intended for the sole benefit of, eligible patients and may not be transferred to or utilized for the benefit of third parties, including, without limitation, third party payers, pharmacy benefit managers, or the agents of either.
  • Co-Pay Card cannot be combined with any other external savings, free trial or similar offer for the specified prescription (including any program offered by a third party payer or pharmacy benefit manager, or an agent of either, that adjusts patient cost-sharing obligations, through arrangements that may be referred to as “accumulator” or “maximizer” programs)
  • Third party payers, pharmacy benefit managers, or the agents of either, are prohibited from assisting patients with enrolling in the Co-Pay Card program.
  • Co-Pay Card will be accepted only at participating pharmacies. 
  • If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer.
  • This Co-Pay Card is not health insurance.
  • Offer good only in the U.S. and Puerto Rico.
  • Co-Pay Card is limited to 1 per person during this offering period and is not transferable.
  • A Co-Pay Card may not be redeemed more than once per 30 days per patient.
  • No other purchase is necessary.
  • Data related to your redemption of the Co-Pay 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 Co-Pay Card redemptions and will not identify you.
  • Pfizer reserves the right to rescind, revoke or amend this offer without notice.
  • Offer expires 12/31/2025
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 www.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 Data Savings for eligible patients

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INDICATION

Premarin® (conjugated estrogens) 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. 

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) 0.625mg alone relative to placebo. The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism, stroke, and myocardial infarction in postmenopausal women with daily oral CE 0.625mg combined with medroxyprogesterone acetate (MPA) 2.5mg relative to placebo. 

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.

 

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE or CE and MPA, and other dosage forms of estrogen or combinations and dosage forms of estrogens and progestins. 

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.

 

Consistent with the WHI clinical trials, observational studies have also reported an increased risk of breast cancer for estrogen plus progestin therapy, and a smaller increased risk for estrogen-alone therapy, after several years of use. One large meta-analysis of prospective cohort studies reported increased risks that were dependent upon duration of use and could last up to >10 years after discontinuation of estrogen plus progestin therapy and estrogen‑alone therapy. Extension of the WHI trials also demonstrated increased breast cancer risk associated with estrogen plus progestin therapy. 


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 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.

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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