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WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
Estrogen-Alone Therapy
Endometrial Cancer
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 [see Warnings and Precautions ].
Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3), and Clinical Studies (14.3, 14.4)].
The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo [see Warnings and Precautions and Clinical Studies].
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions Use in Specific Populations (8.5), and Clinical Studies].
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other forms of estrogens.
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.
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3), and Clinical Studies (14.3, 14.4)].
The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions and Clinical Studies].
The WHIMS estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions Use in Specific Populations (8.5), and Clinical Studies].
Breast Cancer
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions and Clinical Studies].
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.
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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CLIMARA SUMMARY
Climara® , estradiol transdermal system, is designed to release 17(beta)-estradiol continuously upon application to intact skin. Six (6.5, 9.375, 12.5, 15.0, 18.75 and 25.0 cm2) systems are available to provide nominal
in vivo
delivery of 0.025, 0.0375, 0.05, 0.060, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 6.5, 9.375, 12.5, 15.0, 18.75 or 25.0 cm2, and contains 2.0, 2.85, 3.8, 4.55, 5.7 or 7.6 mg of estradiol USP respectively. The composition of the systems per unit area is identical.
Climara® is indicated in the:
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Treatment of moderate to severe vasomotor symptoms associated with the menopause.
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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.
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Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
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Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
Estrogen therapy reduces bone resorption and retards or halts postmenopausal bone loss. Studies have shown an approximately 60% reduction in hip and wrist fractures in women whose estrogen therapy was begun within a few years of menopause. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as 6 years after menopause, estrogen prevents further loss of bone mass for as long as treatment is continued. When estrogen therapy is discontinued, bone mass declines at a rate comparable to the immediate postmenopausal period.
Early menopause is one of the strongest predictors for the development of osteoporosis in all women. Other factors associated with osteoporosis include genetic factors, lifestyle and nutrition.
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NEWS HIGHLIGHTS
Published Studies Related to Climara (Estradiol)
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
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
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
Reports of Suspected Climara (Estradiol) Side Effects
Hot Flush (70),
Product Adhesion Issue (27),
Application Site Rash (21),
Drug Ineffective (13),
NO Adverse Event (13),
Headache (12),
Insomnia (12),
Fatigue (10),
Application Site Erythema (10),
Application Site Reaction (9), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 10 ratings/reviews, Climara has an overall score of 6.80. The effectiveness score is 7.60 and the side effect score is 7.20. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Climara review by 37 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | surgical menopause |
| Dosage & duration: | | .025 (dosage frequency: one patch per week) for the period of 2 years continually and currently |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Immediately after a complete hysterectomy, menopause set in. Night sweats and insomnia were making life difficult. Immediately after starting the Climara patch, all menopausal symptoms were relieved. |
| Side effects: | | I have not experienced any side effects except when dosage was increased. Side effects then were acne and headaches. Upon reducing the dosage to the current .025, all side effects were relieved. |
| Comments: | | Treatment entails applying one patch per week. |
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| | Climara review by 47 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | perimenopause |
| Dosage & duration: | | 1 patch (dosage frequency: once weekly) for the period of continuously |
| Other conditions: | | fibromyalgia |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I began taking Climara for perimenopause issues-- insomnia, horrible PMS, moodiness, night sweats. It helped for these issues. |
| Side effects: | | The main side effects I experienced with Climara were bloating, weight gain and indigestion/gas. I gained 8 pounds in two months! As soon as I stopped the drug, the bloating and gas disappeared, and my weight gain is returning to normal. |
| Comments: | | Climara is meant to be used with a complementary progesterone subscription. I took it in pill form. Now I am planning to try Amberen, a natural supplement which is supposed to balance the endocrine system. Got my fingers crossed! |
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| | Climara review by 51 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | hormone replacement therapy |
| Dosage & duration: | | .075mg/day taken one patch per week for the period of one week |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | no positive benefits |
| Side effects: | | mood changes, weight gain (4 pounds in 3 days!) extremely emotional. depression |
| Comments: | | I had been using the trade brand of this patch, Climara for several months with positive results. One month my local pharmacy was out of the trade brand and offered to fill the prescription with the generic brand and because I was in a hurry to catch a plane to go on a vacation, I agreed, thinking they had to be similar. Wrong! To begin with, the generic patch is twice the size and thickness of the trade brand - don't even think of wearing tight clothes while sporting one of these! (I laughlingly told my husband we could always use one to patch a flat tire if needed, but soon it wasn't so funny.) Within a day or two I knew something was wrong, but hadn't yet identified the problem. I couldn't stop crying about nothing in particular. It seemed as if overnight, my world had become very sad and depressing. I immediately began to gain weight, despite no change in my dietary habits. After finally putting two and two together, I ripped it off and contacted my local pharmacist to see if anyone else had complained of similar experiences. After rechecking my prescription, the pharmacist noticed my physician had marked "no generics". Apparently, he had a good reason for this choice as this was not his usual stance on generics. The pharmacist refilled my prescription with the trade brand and all was quickly back to normal. I usually have no problem with genereic brands, but unfortunately, no more generic estradiol for me! |
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Page last updated: 2015-08-10
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