WARNINGS
- ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA.
Three independent case control studies have reported an increased risk of endometrial cancer in postmenopausal women exposed to exogenous estrogens for prolonged periods. 1-3 This risk was independent of the other known risk factors for endometrial cancer. These studies are further supported by the finding that incidence rates of endometrial cancer have increased sharply since 1969 in eight different areas of the United States with population-based cancer reporting systems, an increase which may be related to the rapidly expanding use of estrogens during the last decade. 4
The three case control studies reported that the risk of endometrial cancer in estrogen users was about 4.5 to 13.9 times greater than in nonusers. The risk appears to depend on both duration of treatment1 and on estrogen dose.3 In view of these findings, when estrogens are used for the treatment of menopausal symptoms, the lowest dose that will control symptoms should be utilized and medication should be discontinued as soon as possible. When prolonged treatment is medically indicated, the patient should be reassessed on at least a semiannual basis to determine the need for continued therapy. Although the evidence must be considered preliminary, one study suggests that cyclic administration of low doses of estrogen may carry less risk than continuous administration, 3 it therefore appears prudent to utilize such a regimen.
Close clinical surveillance of all women taking estrogens is important. In all cases of undiagnosed persistent or recurring abnormal vaginal bleeding, adequate diagnostic measures should be undertaken to rule out malignancy.
There is no evidence at present that "natural" estrogens are more or less hazardous than "synthetic" estrogens at equiestrogenic doses. - ESTROGENS SHOULD NOT BE USED DURING PREGNANCY.
The use of female sex hormones, both estrogens and progestogens, during early pregnancy may seriously damage the offspring. It has been shown that females exposed in utero to diethylstilbestrol, a non-steroidal estrogen, have an increased risk of developing in later life a form of vaginal or cervical cancer that is ordinarily extremely rare. 5,6 This risk has been estimated as not greater than 4 per 1000 exposures. 7 Furthermore, a high percentage of such exposed women (from 30 to 90 percent) have been found to have vaginal adenosis,8-12 epithelial changes of the vagina and cervix. Although these changes are histologically benign, it is not known whether they are precursors of malignancy. Although similar data are not available with the use of other estrogens, it cannot be presumed they would not induce similar changes.
Several reports suggest an association between intrauterine exposure to female sex hormones and congenital anomalies, including congenital heart defects and limb reduction defects. 13-16 One case control study16 estimated a 4.7-fold increased risk of limb reduction defects in infants exposed in utero to sex hormones (oral contraceptives, hormone withdrawal tests for pregnancy, or attempted treatment for threatened abortion). Some of these exposures were very short and involved only a few days of treatment. The data suggest that the risk of limb reduction defects in exposed fetuses is somewhat less than 1 per 1000.
In the past, female sex hormones have been used during pregnancy in an attempt to treat threatened or habitual abortion. There is considerable evidence that estrogens are ineffective for these indications, and there is no evidence from well controlled studies that progestogens are effective for these uses.
If ESTRATEST® or ESTRATEST® H.S. is used during pregnancy, or if the patient becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus, and the advisability of pregnancy continuation. - CARDIOVASCULAR AND OTHER RISKS
ESTRATEST® and ESTRATEST® H.S. Tablets do not contain a progestin. ESTRATEST® and ESTRATEST® H.S. Tablets are an Estrogen/Androgen product.
Estrogens with or without progestins should not be used for the prevention of cardiovascular disease.
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 during 5 years of treatment with conjugated equine estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo (see CLINICAL PHARMACOLOGY, Clinical Studies). Other doses of conjugated estrogens with medroxyprogesterone and other combinations of estrogens and progestins were not studied in the WHI 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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ESTRATEST SUMMARY
ESTRATEST® Each dark green, capsule shaped, sugar-coated oral tablet contains: 1.
ESTRATEST® and ESTRATEST® H.S. are indicated in the treatment of:
Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.)
ESTRATEST® and ESTRATEST® H.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (See BOXED WARNING).
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NEWS HIGHLIGHTSMedia Articles Related to Estratest (Esterified Estrogens)
AACE Issues New Medical Guidelines For Proper And Ethical Use Of Growth Hormone
Source: Endocrinology News From Medical News Today [2009.11.04]
The American Association of Clinical Endocrinologists (AACE) released new medical guidelines for the accurate diagnosis and effective ethical treatment of growth hormone deficiency in affected patients. Growth hormone replacement therapy has proven useful for children and adults with scientifically proven growth hormone deficiency.
Published Studies Related to Estratest (Esterified Estrogens)
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.
Comparative effects of oral esterified estrogens with and without methyltestosterone on endocrine profiles and dimensions of sexual function in postmenopausal women with hypoactive sexual desire. [2003.06]
OBJECTIVE: In some women, a decline in sexual interest accompanies a relative androgen insufficiency after menopause. We sought to characterize the hormonal effects of the combination of oral esterified estrogens and methyltestosterone and to investigate whether this regimen improves hypoactive sexual desire.
Clinical Trials Related to Estratest (Esterified Estrogens)
A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone [Active, not recruiting]
Low testosterone is a condition that occurs when the body is unable to produce sufficient
quantities of testosterone. The medical name for low testosterone is hypogonadism.
Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of
energy and mood swings. The goal of testosterone replacement therapy is to return
testosterone levels to the normal range and relieve symptoms.
The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to
maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18
to 75 years. This will be determined by blood sampling at specified times during the study.
The study is also intended to evaluate the tolerability of Fortigel, which will be applied to
the skin each day throughout the study period.
Effect of Androgel on Type 2 Diabetic Males With Hypogonadism [Recruiting]
This is to study the effect of replacing testosterone on different inflammatory cells in
type 2 diabetics with low testosterone levels.
Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride [Completed]
The combination of testosterone and dutasteride is intended for use in hypogonadal men. This
study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone
administered with and without dutasteride
Efficacy and Safety of Androgel in the Treatment of Hypogonadal and Low Testosterone Men With Type 2 Diabetes [Completed]
This study is to investigate how well Androgel, when tested against placebo gel, helps to
control blood sugar levels in males with type 2 diabetes who have low testosterone (the main
male hormone) blood levels and are taking oral diabetic medicines alone or in combination
with insulin.
Testosterone Replacement in Diabetes With Vascular Disease (Version 2) [Recruiting]
Diabetes is a major cause of peripheral vascular disease(PVD) and is associated with male
hypogonadism. Diabetes and PVD are both associated with arterial stiffness and intima - media
thickness which are also related to severity of the clinical syndrome of PVD. Artificially
induced hypogonadism results in increasing arterial stiffness whilst testosterone is known
to improve risk factors for vascular disease and act as a vasodilator. The purpose of this
pilot study is to assess the effect of testosterone treatment on PVD arterial stiffness and
intima-media thickness in men with type 2 diabetes and hypogonadism,
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Estratest has an overall score of 10. The effectiveness score is 10 and the side effect score is 9. The scores are on ten point scale: 10 - best, 1 - worst.
| | Estratest review by 58 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | menopausal symptoms |
| Dosage & duration: | | hs (dosage frequency: every day) for the period of about 3 years |
| Other conditions: | | none |
| Other drugs taken: | | low dose cortisol | | |
Reported Results |
| Benefits: | | Completely stopped hot flashes and night sweats. (I think there was also some mild improvement in skin thickness as well but it certainly did not end cellulite!) |
| Side effects: | | Initially took full strenth tabs and I did experience some menstrual bleeding as a result. This did not happen with the hs tabs.
On the other hand, thanks to the increased amount of tetosterone in the full strenght tabs, my interest in sex improved on these. Not so much with the half strength tabs. |
| Comments: | | I had a salivary estrogen level test done while I was on this medication. Although it completely stopped menopausal symptoms my estrogen levels were still very low. So I'm not particularly concerned about adverse effects of estrogen treatment on these... |
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| | Estratest review by 51 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | extreme hot flashes |
| Dosage & duration: | | larger dose (dosage frequency: daily) for the period of 1 year |
| Other conditions: | | total hysterectomy, acid reflux |
| Other drugs taken: | | prilosec-20mg daily | | |
Reported Results |
| Benefits: | | no hot flashes, increased libido, increased energy level, seemed to feel more zestful. prilosec controlled acid reflux well |
| Side effects: | | didn't notice any side effects, i think it can increase risk of breast cancer, and it can actually help to decrease chance of alzheimer's |
| Comments: | | I have been able to stop taking to prilosec since I have lost weight. I only take it as needed now, maybe a couple times a week. I am currently still taking the estratest for hot flashes and it is working well. |
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Page last updated: 2009-11-04
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