Climara (Estradiol Transdermal) - Summary

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 indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Climara (Estradiol)

The Prevention of Post-Partum Relapses with Progestin and Estradiol in Multiple Sclerosis (POPART'MUS) trial: rationale, objectives and state of advancement. [2009.11.15]
Multiple sclerosis (MS) affects 1 in 1000 people in western countries, mainly women in their childbearing years. It is an autoimmune disease of the central nervous system, which results in a chronic focal inflammatory response with subsequent demyelination and axonal loss... Assuming the results of the trial to be positive, this new treatment could be considered in the relapsing-remitting phase of the disease in women afar from pregnancy and post-partum.

A randomized controlled trial of a low-dose combined oral contraceptive containing 3 mg drospirenone plus 20 microg ethinylestradiol in the treatment of acne vulgaris: lesion counts, investigator ratings and subject self-assessment. [2009.09]
OBJECTIVE: To assess the efficacy of a combined oral contraceptive (COC) containing 3 mg drospirenone (drsp) plus 20 microg ethinylestradiol (EE) administered in 24 days of active treatment followed by a four-day hormone-free interval (24/4 regimen) compared with placebo for the treatment of moderate acne vulgaris... CONCLUSION: The 3 mg drsp/20 microg EE COC administered in a 24/4 regimen significantly reduced acne lesions.

Steady-state pharmacokinetics following application of a novel transdermal estradiol spray in healthy postmenopausal women. [2009.09]
This study was designed to evaluate the steady-state pharmacokinetics (PK) of estradiol and its metabolites, estrone and estrone sulfate, following application of a novel estradiol transdermal spray to healthy postmenopausal women. Participants were randomly assigned in parallel to receive 1-, 2-, or 3-spray doses (24 participants/dose level) of a 1.7% estradiol metered-dose transdermal spray (1.53 mg/spray) once daily for 14 days...

Lower-dose vs high-dose oral estradiol therapy of hormone receptor-positive, aromatase inhibitor-resistant advanced breast cancer: a phase 2 randomized study. [2009.08.19]
CONTEXT: Estrogen deprivation therapy with aromatase inhibitors has been hypothesized to paradoxically sensitize hormone-receptor-positive breast cancer tumor cells to low-dose estradiol therapy. OBJECTIVE: To determine whether 6 mg of estradiol (daily) is a viable therapy for postmenopausal women with advanced aromatase inhibitor-resistant hormone receptor-positive breast cancer... CONCLUSIONS: In women with advanced breast cancer and acquired resistance to aromatase inhibitors, a daily dose of 6 mg of estradiol provided a similar clinical benefit rate as 30 mg, with fewer serious adverse events. The efficacy of treatment with the lower dose should be further examined in phase 3 clinical trials. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00324259.

Evaluation of different add-back estradiol and progesterone treatments to gonadotropin-releasing hormone agonist treatment in patients with premenstrual dysphoric disorder. [2009.08]
OBJECTIVE: The aim of this study was to investigate which add-back hormone replacement therapy would be most beneficial in terms of mood effects for patients with premenstrual dysphoric disorder who are receiving gonadotropin-releasing hormone agonist therapy... CONCLUSION: Based on the findings of the present study, long-cycle add-back treatment to avoid frequent progestagen use appears to be most beneficial for patients with premenstrual dysphoric disorder.

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.

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.

Treatment of Hot Flushes in Asian Women With Ultra-Low Dose Estradiol Patch [Completed]
150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.

Vasomotoric Symptoms Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination [Completed]

Neoadjuvant Estradiol or Androgen Deprivation in Clinically Localized Prostate Cancer [Completed]
Prostate cancer is the most commonly diagnosed cancer among males in the U. S. More than 220,000 men will be diagnosed with prostate cancer in the USA this year and more that 31,000 will die of this disease.

Androgen deprivation, the elimination of testosterone and its active metabolites, remains the single most effective intervention available for the treatment of advanced prostate carcinoma. Androgen deprivation induces an immune response to normal prostate and prostate cancer, which is usually short-lived. Estradiol induces activation of many arms of the immune system and may be a more effective and long lasting means of inducing immunity to prostate tissue.

This study will treat clinically localized prostate cancer patients with either estrogens, or standard androgen deprivation without estrogens, prior to prostatectomy in order more completely to describe immune regulation by estradiol in men. Control tissue from patients who have not been treated with androgen deprivation will be procured from the Northwest Special Projects in Oncology Research Excellence (SPORE) tissue core and used as comparisons against the cancers treated before prostatectomy. Tumors removed at prostatectomy, tissue samples and blood samples will be assessed for immune system changes.

more trials >>

PATIENT REVIEWS / RATINGS / COMMENTS

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 52 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		menopause, memory loss, night sweats, low libido
Dosage & duration:		1 patch weekly (dosage frequency: 1 patch every 7 days) for the period of week 3
Other conditions:		high blood pressure
Other drugs taken:		adalat 30 MG, daily vitamin, vitamin E
		Reported Results
Benefits:		nothing noticeable really, night sweats improved (slightly), memory, not as fuzzy
Side effects:		Weight gain 4 lbs, my weight has always been stable, bloatiness/gas (uncomfortable) hair loss (more than usual and thinner), depression (crying for no reason)
Comments:		Change patch every 7 days. Very difficult keeping the patch on. I'm going to ask the Dr. for different type of patch. Heard Vivelle is smaller and stays on bettetr.

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!