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 or 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 oral 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.
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ESTRACE SUMMARY
Each gram of ESTRACE® (estradiol vaginal cream, USP, 0.01%) contains 0.1 mg estradiol in a nonliquefying base containing purified water, propylene glycol, stearyl alcohol, white ceresin wax, mono- and di-glycerides, hypromellose 2208 (4000 cps), sodium lauryl sulfate, methylparaben, edetate di-sodium and tertiary -butylhydroquinone.
ESTRACE (estradiol vaginal cream, USP, 0.01%) is indicated in the treatment of vulvar and vaginal atrophy.
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NEWS HIGHLIGHTS
Published Studies Related to Estrace (Estradiol Vaginal)
Sexual function in women on estradiol or venlafaxine for hot flushes: a
randomized controlled trial. [2014]
estradiol or venlafaxine for hot flushes... CONCLUSION: Overall sexual function among nondepressed midlife women experiencing
Effect of estradiol valerate on endometrium thickness during clomiphene
citrate-stimulated ovulation. [2014]
CONCLUSIONS: We concluded that the addition of 6 mg/day EV following the CC
[Efficacy and safety of a combined oral contraceptive containing drospirenone 3
mg and ethinylestradiol 20 µg in the treatment of premenstrual dysphoric
disorder: a randomized, double blind placebo-controlled study]. [Article in Chinese] [2014]
with placebo in reducing symptoms of premenstrual dysphoric disorder (PMDD)... CONCLUSIONS: YAZ could improve symptoms of PMDD better than placebo, while
Impact of estradiol valerate/dienogest on work productivity and activities of
daily living in women with heavy menstrual bleeding. [2013]
estradiol valerate/dienogest (E2V/DNG; Qlaira(®)/Natazia(®)) compared to placebo... CONCLUSIONS: E2V/DNG was shown to have a consistent positive impact on work
Effects of tibolone or continuous combined oestradiol/norethisterone acetate on
glucose and insulin metabolism. [2013]
insulin metabolism in postmenopausal women... CONCLUSIONS: Tibolone reduces insulin sensitivity. Healthy postmenopausal women
Clinical Trials Related to Estrace (Estradiol Vaginal)
A Comparison of Estradiol Vaginal Cream to Estrace� Cream in 350 Postmenopausal Females With Atrophic Vaginitis [Completed]
Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem� 10 mcg and Compare to Placebo [Completed]
The purpose of this study is to compare the safety and efficacy of generic Estradiol
Vaginal Inserts, USP 10 mcg to the reference product Vagifem 10 mcg and to determined
whether the efficacy of each of the 2 active treatments is superior to that of the placebo.
Efficacy and Safety Of Spil's Estradiol Vaginal Tablet [Terminated]
Estradiol vaginal tablet is a tablet which hydrates upon contact with moisture, releasing
17-estradiol.
The estradiol in estradiol vaginal tablet is chemically and biologically identical to the
endogenous human estradiol and is therefore classified as a human estrogen.
The purpose of this study is to demonstrate clinical endpoint bioequivalence of SPIL's
Estradiol vaginal tablet, 10mcg estradiol to the reference listed drug (Vagifem)which is
approved and marketed in the US.
Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women [Terminated]
This trial is conducted in Europe. The aim of this trial is to investigate the preventive
effect of treatment with estradiol vaginal tablets on recurrent urinary tract infections
(RUTI) in post-menopausal women with signs of urogenital ageing (UGA).
Evaluate Long-Term Safety and Efficacy WC3011 [Completed]
This is an open-label extension study evaluating the long-term safety and efficacy of WC3011
in non-hysterectomized, healthy, postmenopausal women with vulvovaginal atrophy.
Reports of Suspected Estrace (Estradiol Vaginal) Side Effects
Breast Cancer Female (16),
Headache (6),
Breast Cancer (5),
Dizziness (4),
Abdominal Distension (4),
Muscle Spasms (4),
Back Pain (4),
Drug Ineffective (3),
Osteoporosis (3),
Pain (3), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 8 ratings/reviews, Estrace has an overall score of 8.38. The effectiveness score is 9 and the side effect score is 7.75. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Estrace review by 57 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | menopause |
| Dosage & duration: | | .05mg taken once daily for the period of three years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | no mood swings or hot flsshes |
| Side effects: | | moderate weight gain |
| Comments: | | take one pill daily |
|
| | Estrace review by 45 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | surgical menopause |
| Dosage & duration: | | 2mg taken once per day for the period of 17 years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | reduction in mood swings;night sweats;wt. gain |
| Side effects: | | gallbladder disease;reflux |
| Comments: | | This medication was working well until it changed from round tablet to oblong tablet. Now need to take higher dose for similar effect. Has not worked as well since name brand was sold to different company and shape change. I wonder if there are women having same problem. Had surgical menopause for 19 years. |
|
| | Estrace review by 47 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | hysterectomy/menopause |
| Dosage & duration: | | 0.5 mg taken 3x weekly for the period of 2 months |
| Other conditions: | | digestive disorder/severe menopausal symptoms |
| Other drugs taken: | | bioidentical estriol/testosterone | | |
Reported Results |
| Benefits: | | The application of estrace relieved vaginal dryness virtually overnight. It also caused reduction of pain during intercourse. Improved sex drive and response. |
| Side effects: | | The application of estrace didn't appear to have side effects initially, however, upon continued use severe irritation of the vaginal lining occurred as well as a severe yeast infection. Yeast infection was so severe it required prescription medication to clear up. |
| Comments: | | Estrace was applied vaginally 3x weekly. |
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Page last updated: 2015-08-10
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