Estrogens and 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 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders and Malignant neoplasms, Breast cancer)
The WHI study reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years of treatment with oral conjugated estrogens (CE 0.625 mg) relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular disorders)
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 CE 0.625 mg combined with MPA 2.5 mg and during 5.2 years of treatment with CE 0.625 mg alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES, 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 PRO SUMMARY
Climara Pro® (Estradiol/Levonorgestrel Transdermal System) is an adhesive-based matrix transdermal patch designed to release both estradiol and levonorgestrel, a progestational agent, continuously upon application to intact skin.
The 22 cm2 Climara Pro system contains 4.4 mg estradiol and 1.39 mg levonorgestrel and provides a nominal delivery rate (mg per day) of 0.045 estradiol and 0.015 levonorgestrel.
In women with an intact uterus, Climara Pro is indicated in the:
- Treatment of moderate to severe vasomotor symptoms associated with menopause.
- 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.
Risk factors for osteoporosis include low bone mineral density, low estrogen levels, family history of osteoporosis, previous fracture, small frame (low BMI), light skin color, smoking, and alcohol intake. Response to therapy can be predicted by pre-treatment serum estradiol, and can be assessed during treatment by measuring biochemical markers of bone formation/resorption, and/or bone mineral density.
Published Studies Related to Climara PRO (Estradiol / Levonorgestrel)
Simultaneous estradiol and levonorgestrel transdermal delivery from a 7-day patch: in vitro and in vivo drug deliveries of three formulations. [2007.04]
A new drug-in-adhesive transdermal patch was developed to deliver both estradiol and levonorgestrel through the skin over a 7-day period, but at different rates. This report elucidates the in vitro and in vivo biopharmaceutical studies that were necessary during the development of this product... One of the test products is now marketed as Climara Pro.
Levonorgestrel and 17beta-estradiol given transdermally for the prevention of postmenopausal osteoporosis. [2005.02.14]
AIM: To evaluate the efficacy and safety of a new transdermal continuous combined hormone replacement therapy (HRT) for the prevention of postmenopausal osteoporosis... CONCLUSION: The transdermal combination of 17beta-estradiol and levonorgestrel has a positive effect on BMD in an osteopenic postmenopausal population. Furthermore, a high safety profile was observed.
A 1-year randomized study to evaluate the effects of a dose reduction in oral contraceptives on lipids and carbohydrate metabolism: 20 microg ethinyl estradiol combined with 100 microg levonorgestrel. [2005.02]
OBJECTIVES: To evaluate the impact on lipid and carbohydrate variables of a combined one-third ethinyl estradiol (EE)/levonorgestrel (LNG) dose reduction in oral contraceptives... CONCLUSION: Similar effects on the lipid and carbohydrate profiles were found for both preparations. The balanced one-third EE dose reduction in this new oral contraceptive caused slightly lower, but insignificant, changes in the lipid and carbohydrate variables compared with the reference treatment.
Superior cycle control with a contraceptive vaginal ring compared with an oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel: a randomized trial. [2005.02]
BACKGROUND: This trial was conducted to compare cycle control with vaginal ring a combined contraceptive vaginal ring, and a combined oral contraceptive (COC) delivering 30 mug ethinylestradiol (EE) and 150 mug levonorgestrel... CONCLUSIONS: Cycle control with vaginal ring was excellent and superior to that of a COC containing 30 mug EE.
Cycle control, quality of life and acne with two low-dose oral contraceptives containing 20 microg ethinylestradiol. [2004.06]
OBJECTIVES: Poor cycle control and tolerability can be reasons for irregular pill intake. This study compared the tolerability of two low-dose oral contraceptives and their effect on cycle control... CONCLUSIONS: 20EE/DSG provided better cycle control than 20EE/LNG with less treatment discontinuation due to unacceptable bleeding. There were no apparent differences between the two groups regarding tolerability and quality of life. There was less acne with 20EE/DSG. Copyright 2004 Elsevier Inc.
Clinical Trials Related to Climara PRO (Estradiol / Levonorgestrel)
Changes in Oral Contraceptive Hormones After Gastric Bypass Surgery [Recruiting]
This study will attempt to determine whether having gastric bypass surgery changes the way
that the gut absorbs hormones from birth control pills. It is believed that, because gastric
bypass surgery causes malabsorption of nutrients and some medications, the levels of birth
control hormones after the surgery will be lower than in women before they have the surgery.
The investigators will ask several women to take a pack of birth control pills before having
bypass surgery, and then another pack several months after surgery. The investigators will
measure hormone levels in the blood. The investigators will also measure outcomes that may
tell us how well the birth control pills are working, such as ultrasounds of the uterus and
ovaries, and examination of the cervix.
Relationship Between the Menstrual Cycle and Heart Disease in Women [Completed]
Women who have regular menstrual cycles have a lower risk of heart disease than men of the
same age or women who no longer have menstrual cycles. The purpose of this study is to help
determine why the menstrual cycle causes a lower risk of heart disease. The investigators
believe that the hormones (estradiol and progesterone) produced during the menstrual cycle,
as well as the normal processes occurring in the follicle and corpus luteum (transformed
follicle), change levels of "good" and "bad" cholesterol in the blood-stream. These levels
of good and bad cholesterol are an important risk factor for heart disease. Therefore, our
goal is to determine what effects each of these factors (estradiol, progesterone, follicle,
corpus luteum) have on the levels of good and bad cholesterol in the woman's bloodstream. As
many women take birth control pills, which contain synthetic forms of estradiol and
progesterone that block ovulation and development of a corpus luteum, the investigators also
want to determine what effect one common type of birth control pill has on levels of good
and bad cholesterol.
Efficacy and Safety Study in Postmenopausal Women to Determine the Lowest Effective Dose for Relief of Moderate to Severe Hot-Flushes [Completed]
To determine the lowest effective dose of estradiol by comparing E2/LNG (2. 2mg/0. 69mg) and
E2 (1. 0mg) dose with placebo in decreasing the frequency and severity of moderate to severe
hot flushes in postmenopausal women
Transdermal Estrogen in Older Premenopausal Women With Anorexia Nervosa [Recruiting]
Decreased bone strength is a common and serious medical problem present in many women with
anorexia nervosa. Women with decreased bone strength are more likely to suffer broken bones
than women with normal bone strength.
This study will investigate whether the use of transdermal estrogen can improve bone mineral
density (BMD) and bone microarchitecture in women with anorexia nervosa anorexia nervosa
when used for 6 months.
Reports of Suspected Climara PRO (Estradiol / Levonorgestrel) Side Effects
Hot Flush (29),
Product Adhesion Issue (22),
Application Site Rash (14),
NO Adverse Event (12),
Vaginal Haemorrhage (11),
Night Sweats (7),
Application Site Erythema (6),
Application Site Irritation (6), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 2 ratings/reviews, Climara PRO has an overall score of 6.50. The effectiveness score is 7 and the side effect score is 7. The scores are on ten point scale: 10 - best, 1 - worst.
Climara PRO review by 53 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || insomnia, night sweats, hot flashes|
|Dosage & duration:|| || 0.045/0.015M (dosage frequency: 1 patch/weekly) for the period of 3 months|
|Other conditions:|| || mood swings, depressed mood|
|Other drugs taken:|| || otc, herbals (soy, melatonin, exercise)|
|Benefits:|| || Insomnia, night sweats and hot flashes stopped with in 72 hours.
Mood has stabilized, memory has improved and I am feeling more focused. libido has returned and Skin feels better. |
|Side effects:|| || break through bleeding every other week to every two weeks in 3 month of use.|
|Comments:|| || Apply patch 1/week, follow up with MD in 5 weeks.|
Climara PRO review by 53 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Marginally Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || hot flashes|
|Dosage & duration:|| || .045/.015 mg/day taken weekly for the period of 1 week|
|Other conditions:|| || fibromyalgia, sjogrens|
|Other drugs taken:|| || none|
|Benefits:|| || There was a small reduction in my hot flashes but the side effect was bothering me too much to stay on the patch longer to see if it would have totally eliminated them over time.|
|Side effects:|| || I developed gas pains in my abdomen where the patch was. I was very bloated and uncomfortable. I think I gained a couple of pounds too and I had only been using it for a week.|
|Comments:|| || The doctor thought I should try the patch because it would bypass my liver. I have been taking pills for eight years and didn't really have any side effects - so I returned to my original treatment of estradiol and provera.|
Page last updated: 2007-08-04