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Climara (Estradiol Transdermal) - Summary

 
 



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 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 or dementia. (See Warnings, Cardiovascular disorders and Dementia.)

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 0.625mg) combined with medroxyprogesterone acetate (MPA 2.5mg) relative to placebo. (See Clinical Pharmacology, Clinical Studies and Warnings, Cardiovascular disorders and Malignant neoplasms, Breast cancer).

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. (See Clinical Pharmacology, Clinical Studies and Warnings, Dementia and PRECAUTIONS, Geriatric use.)

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.

 

CLIMARA SUMMARY

Climara®
(Estradiol Transdermal System)

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:

  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. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
  4. 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.
See all Climara indications & dosage >>

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

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

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

more studies >>

Clinical Trials Related to Climara (Estradiol)

Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climara« Transdermal System 0.025 mg/Day [Completed]
The primary objective of this study was to compare the adhesive quality of a new formulation of the Mylan Estradiol Transdermal System with that of Climara« Transdermal System following a single system application in 80 healthy postmenopausal female volunteers. As a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.

Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients [Recruiting]
The purpose of this clinical research study is to determine whether the ESTRING or a special preparation of a testosterone cream inserted vaginally are safe for use in breast cancer patients. This study will also evaluate if either of these treatments can improve symptoms of vaginal dryness or decreased sexual interest that are related to your treatment for breast cancer.

Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women [Completed]
The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8 weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the relief of vasomotor symptoms and who have hypertension.

Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen [Recruiting]
The purpose of this study is to see if Vagifem« 10mcg is safe for women who have had breast cancer. Vagifem is an estrogen product. It is a tiny tablet that is inserted into the vagina. It relieves vaginal dryness. Women who have had breast cancer are usually told not to take estrogen. This is because estrogen use can lead to a breast cancer recurrence or a new primary breast cancer. It is unclear if the estrogen in Vagifem is only absorbed in the vagina. It may be absorbed into the blood stream for a short time and may cause a brief rise in your estrogen level. However, there is no clear evidence that this would cause any bad effects in patients with breast cancer. How much, if any, of these topical estrogens are absorbed through the vagina is not known. We also do not know what the impact is of low dose estrogen absorption on breast cancer outcomes. Also, the absorption should decrease as the mucus membranes are restored after estrogen exposure.

Effect of Estradiol+Drospirenone Versus Estradiol+MPA on Endothelial Function [Recruiting]
This study compares the effects of two common hormone medications on the heart and blood vessels of healthy post-menopausal women over the age of 45.

The study will take place over the course of about 5 months. Each subject will take two different medications over two six-week periods. They will be randomized at the beginning of the study to either estradiol+medroxyprogesterone acetate or estradiol+drospirenone for the first period, and will receive the other medication the second six-weeks of the study. At the very beginning of the study and at the end of each six-week treatment period, subjects will come to the hospital various tests including non-invasive blood vessel imaging tests, blood draws to test the levels of certain hormones in the body, an oral glucose tolerance test, a test to monitor renal blood flow, and 24-hour blood pressure monitoring. Between treatment periods, there will be a four-week medication-free washout period.

more trials >>

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 >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based 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.

 

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!

 

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!

See all Climara reviews / ratings >>

Page last updated: 2014-11-30

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