DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Menest (Esterified Estrogens) - Summary

 
 



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 at equivalent estrogen doses. (See WARNINGS, Malignant neoplasms, Endometrial cancer.)

CARDIOVASCULAR AND OTHER RISKS

Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. (See WARNINGS, Cardiovascular disorders.) The Women’s Health Initiative (WHI) study 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 (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 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 with 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.

 

MENEST SUMMARY

MENEST®
brand of esterified estrogens tablets, USP

Esterified estrogens is a mixture of the sodium salts of the sulfate esters of the estrogenic substances, principally estrone, that are of the type excreted by pregnant mares. The content of total esterified estrogens is not less than 90 percent and not more than 110 percent of the labeled amount. Esterified estrogens contain not less than 75 percent and not more than 85 percent of sodium estrone sulfate, and not less than 6 percent and not more than 15 percent of sodium equilin sulfate, in such proportion that the total of these two components is not less than 90 percent, all percentages being calculated on the basis of the total esterified estrogens content.

Menest is indicated in the:

  1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.

  2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

  3. Female hypogonadism.

  4. Female castration.

  5. Primary ovarian failure.

  6. Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.

  7. Prostatic carcinoma - palliative therapy of advanced disease.


See all Menest indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Menest (Esterified Estrogens)

Safety and efficacy of low-dose esterified estrogens and methyltestosterone, alone or combined, for the treatment of hot flashes in menopausal women: a randomized, double-blind, placebo-controlled study. [2011.01]
This study evaluated safety and efficacy of esterified estrogens and methyltestosterone administered alone or in combination for the treatment of hot flashes in menopausal women. The 0.30-mg esterified estrogens and 0.30-mg methyltestosterone combination was the lowest effective dose, and our results are consistent with the known safety profile of estrogen and androgen combination products.

Climacteric symptom control after the addition of low-dose esterified conjugated estrogens to raloxifene standard doses. [2007.03]
INTRODUCTION: Hormone therapy (HT) is one the best options for climacteric symptom control; however when women are switched to raloxifene, after several years of HT, they restart with symptoms. OBJECTIVE: To evaluate the effect of the addition of low-dose esterified conjugated estrogens to the conventional dose of raloxifene in the control of climacteric symptoms... CONCLUSION: The treatment that is proposed in this study can constitute a temporary alternative during the period of transition from HT to raloxifene.

Combined esterified estrogens and methyltestosterone versus esterified estrogens alone in the treatment of loss of sexual interest in surgically menopausal women. [2005.07]
OBJECTIVE: To compare the effect of esterified estrogens and methyltestosterone versus esterified estrogens alone on diminished sexual interest in surgically menopausal women... CONCLUSIONS: The mixed results seen with the different sexual function questionnaires may be due to the CSFQ-F-C's lack of specificity for this population. Increased levels of bioavailable and free testosterone paralleled the improved MSIQ item scores. Both the EE and EE/MT treatments were well tolerated.

Combined esterified estrogen and methyltestosterone treatment for dry eye syndrome in postmenopausal women. [2005.06]
PURPOSE: To determine whether systemic replacement with combined esterified estrogen (EE) and methyltestosterone (MT) (EE + MT) would reduce symptoms and promote clinical improvement in postmenopausal women with dry eye syndrome (DES). DESIGN: Retrospective, noncomparative, interventional case series... CONCLUSIONS: Treatment with EE + MT may be efficacious for DES of various etiologies. A randomized placebo-controlled trial is planned to further evaluate these encouraging findings.

Effect of the combination of methyltestosterone and esterified estrogens compared with esterified estrogens alone on apolipoprotein CIII and other apolipoproteins in very low density, low density, and high density lipoproteins in surgically postmenopausal women. [2004.05]
Androgens are known to lower plasma triglycerides, an independent risk factor for coronary heart disease (CHD). Triglycerides are carried in plasma on very low density (VLDL) and low density (LDL) lipoprotein particles... Methyltestosterone may lower plasma triglycerides through a reduction in apoCIII.

more studies >>

Clinical Trials Related to Menest (Esterified Estrogens)

Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes [Completed]
This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women

High-Dose Esterified Estrogens in Treating Postmenopausal Women With Metastatic Breast Cancer That Has Failed Previous Hormone Therapy [Active, not recruiting]
RATIONALE: High doses of esterified estrogens may stop the growth of breast cancer cells that no longer respond to hormone therapy.

PURPOSE: This phase II trial is studying how well high-dose esterified estrogens work in treating postmenopausal women with metastatic breast cancer that has failed previous hormone therapy.

The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women [Terminated]
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets

The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women [Terminated]
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets

Study of the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women [Completed]
To determine whether treatment with ESTRATEST® H. S. Tablets is superior to treatment with esterified estrogens tablets

more trials >>

Reports of Suspected Menest (Esterified Estrogens) Side Effects

Sinus Bradycardia (3)Bradycardia (3)Altered State of Consciousness (3)Penile Size Reduced (2)Compression Fracture (2)Alopecia (2)Confusional State (1)Multi-Organ Failure (1)Interstitial Lung Disease (1)Inappropriate Schedule of Drug Administration (1)more >>


Page last updated: 2011-12-09

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014