BOX WARNING
ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens of equivalent estrogen dose.
CARDIOVASCULAR AND OTHER RISKS
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease.
The Women's Health Initiative (WHI) reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
The Women's Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
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SUMMARY
Each gram of Premarin® (conjugated estrogens) Vaginal Cream contains 0.625 mg conjugated estrogens, USP in a nonliquefying base containing cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil. Premarin Vaginal Cream is applied intravaginally.
Premarin (conjugated estrogens) Vaginal Cream is indicated in the treatment of atrophic vaginitis and kraurosis vulvae.
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NEWS HIGHLIGHTS
Published Studies Related to Premarin Vaginal (Conjugated Estrogens Vaginal)
A randomized, placebo- and active-controlled trial of bazedoxifene/conjugated estrogens for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal women. [2009.09.25]
OBJECTIVES:: The primary objective of the Selective estrogen Menopause And Response to Therapy 3 (SMART-3) trial was to compare the efficacy and safety of two doses of bazedoxifene (BZA)/conjugated estrogens (CE) versus placebo for the treatment of moderate to severe vulvar/vaginal atrophy (VVA) associated with menopause... CONCLUSIONS:: BZA/CE is effective in treating moderate to severe VVA and vaginal symptoms. These data further support the use of a tissue-selective estrogen complex containing BZA/CE as a new menopausal therapy for postmenopausal women.
Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic parameters and overall safety profile. [2009.09]
OBJECTIVE: To evaluate the effects of a tissue-selective estrogen complex (TSEC) composed of bazedoxifene/conjugated estrogens (BZA/CE) on menopausal symptoms, metabolic parameters, and overall safety... CONCLUSION: The TSEC composed of BZA (20 mg)/CE (0.625 or 0.45 mg) is an effective and safe treatment for menopausal symptoms.
Efficacy and safety of low-dose regimens of conjugated estrogens cream administered vaginally. [2009.07]
OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of low-dose conjugated estrogens (CE) cream for treatment of atrophic vaginitis... CONCLUSIONS: Daily and twice-weekly use of low-dose CE cream was equally effective in relieving symptoms of vulvovaginal atrophy. Both regimens showed endometrial safety and sustained efficacy during 1 year of therapy.
Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. [2009.07]
OBJECTIVE: The aim of this study was to evaluate low-dose synthetic conjugated estrogens A (SCE-A) cream administered twice weekly for the treatment of moderate to severe vulvovaginal atrophy (VVA) in a symptomatic postmenopausal population... CONCLUSIONS: A low dose (1 g = 0.625 mg) of SCE-A vaginal cream administered twice weekly was shown to be effective compared with placebo in treating VVA in postmenopausal women for the three coprimary efficacy measures of maturation index, pH, and severity of the MBS.
A randomized study of low-dose conjugated estrogens on sexual function and quality of life in postmenopausal women. [2009.03]
OBJECTIVE: To evaluate the effects of combined vaginal and oral low-dose estrogen plus progestogen therapy (EPT) on the frequency and severity of dyspareunia, sexual function, and quality of life in recently postmenopausal women... CONCLUSIONS: EPT provided a statistically significant improvement compared with placebo in dyspareunia, sexual experience, and quality of life as measured in this study. In general, EPT also improved self-reported sexual perception and enjoyment significantly compared with placebo.
Clinical Trials Related to Premarin Vaginal (Conjugated Estrogens Vaginal)
Two Doses of Conjugated Estrogen (Premarin) in Patients With Androgen-Independent Prostate Cancer [Active, not recruiting]
The purpose of this study is to see if Premarin is useful against androgen-independent
prostate cancer and to help understand how drugs such as Premarin may work.
Study Comparing Premarin® Vaginal Cream Versus Premarin® Oral Tablets in Atrophic Vaginitis [Completed]
The purpose of this study is to characterize the systemic exposure and bioavailability at
steady state of Premarin® Vaginal Cream compared with Premarin® oral tablets in
postmenopausal women with atrophic vaginitis.
Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro) [Completed]
To evaluate three new investigational tablet formulations of the Food and Drug Administration
(FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate
(MPA).
Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. [Completed]
This study will compare the bioequivalence of two new investigational combination
formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed
formulation of Premarin and medroxyprogesterone, Prempro™.
Prempro is indicated for use after menopause in women with a uterus to reduce moderate to
severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around
the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The
purpose of this study is to determine if these new formulations of Premarin and MPA provide
the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.
Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation [Completed]
This study will compare the bioavailabity of three new investigational combination
formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed
formulation of Premarin and MPA, Prempro™. Prempro™ is indicated for use after menopause in
women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe
dryness, itching, and burning, in and around the vagina; and to help reduce your chances of
getting osteoporosis (thin weak bones). The purpose of this study is to determine if these
new formulations of Premarin/MPA provide the same levels of estrogen and MPA in the blood as
Prempro in healthy postmenopausal women.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Premarin Vaginal has an overall score of 9. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Premarin Vaginal review by 64 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | vaginal dryness |
| Dosage & duration: | | 1.5 g three x week (dosage frequency: one to three times per week) for the period of 3 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | restored moisture, decreased itching, decreased urinary symptoms |
| Side effects: | | none |
| Comments: | | Using Premarin cream has almost completely reversed the symptoms of vaginal atrophy such as itching, burning, and urinary discomfort. |
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Page last updated: 2009-10-20
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