Estrogens with or without progestins should not be used for the prevention of cardiovascular disease.
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 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). Other doses of conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI 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.
In women with an intact uterus, Climara Pro is indicated for the following:
- Treatment of moderate to severe vasomotor symptoms associated with menopause
H. PEDIATRIC USE
Climara Pro is not indicated in children.
I. GERIATRIC USE
There have not been sufficient numbers of geriatric patients involved in studies utilizing Climara Pro to determine whether those over 65 years of age differ from younger subjects in their response to Climara Pro.
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)
Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and ClimaraŽ 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 ClimaraŽ 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
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 VagifemŽ 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.
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