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Combipatch (Estradiol / Norethindrone Acetate) - Summary

 
 



WARNING:
CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER, AND PROBABLE DEMENTIA

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 CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders and Probable Dementia)

The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (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 conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders)

The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported 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 CLINICAL STUDIES and WARNINGS, Probable Dementia and PRECAUTIONS, Geriatric Use)

Breast Cancer

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. (See CLINICAL STUDIES and WARNINGS, Malignant Neoplasms, Breast Cancer)

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.

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, Malignant Neoplasms, Endometrial Cancer)

Cardiovascular Disorders and Probable Dementia

Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders and Probable Dementia)

The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone, relative to placebo. (See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders)

The 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 CLINICAL STUDIES and WARNINGS, Probable Dementia and PRECAUTIONS, Geriatric Use)

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage 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.

 

COMBIPATCH SUMMARY

CombiPatch® (estradiol/norethindrone acetate transdermal system) is an adhesive-based matrix transdermal patch designed to release both estradiol, an estrogen, and norethindrone acetate (NETA), a progestational agent, continuously upon application to intact skin.

CombiPatch is indicated in a woman with a uterus for:

  • Treatment of moderate to severe vasomotor symptoms due to menopause.
  • Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
  • Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.

See all Combipatch indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Combipatch (Estradiol / Norethindrone)

Lipids and clotting factors during low dose transdermal estradiol/norethisterone use. [2005.04.11]
OBJECTIVE: To demonstrate the effects of 2-year transdermal continuous combined low-dose estradiol (0.025 mg/day) and norethisterone acetate (0.125 mg/day) on lipid/lipoprotein profile and coagulation/fibrinolysis... CONCLUSIONS: A continuous combined low-dose transdermal patch daily delivering 0.025 mg estradiol and 0.125 mg norethisterone acetate provided beneficial effects on lipid/lipoprotein profile and coagulation/fibrinolysis. The changes were similar to those previously described after higher dose oral and transdermal estrogen/progestogen regimens.

Effects of oral continuous and transdermal cyclic 17-beta estradiol and norethindrone acetate replacement therapy on platelet aggregation in postmenopausal women. [2002.08]
OBJECTIVE: To evaluate the effects of an oral continuous and transdermal cyclic 17-beta estradiol and norethindrone acetate combination on platelet aggregation in post-menopausal women... CONCLUSION: Hormone replacement treatment with a 17-beta estradiol and norethindrone acetate combination either orally continuously or transdermally cyclically and sequentially does not affect platelet aggregation in postmenopausal women.

Positive effects on cardiovascular and breast metabolic markers of oral estradiol and dydrogesterone in comparison with transdermal estradiol and norethisterone acetate. [2002.04.25]
OBJECTIVES: To assess differences in two sequential combined hormone replacement therapy (HRT) products on selected cardiovascular and breast metabolic markers. The products were different concerning the route of administration of estradiol and its combined progestin, either oral or transdermal, and the androgenic properties of progestogens, respectively, dydrogesterone and norethisterone acetate... CONCLUSION: Oral estradiol sequentially combined with dydrogesterone, a non-androgenic progestogen, induced positive changes of some cardiovascular (HDL-C) and breast (SHBG and IGF-I) metabolic markers. These effects were significantly different from those obtained with a transdermal estradiol associated to an androgenic progestogen.

Low dose transdermal estradiol/norethisterone acetate treatment over 2 years does not cause endometrial proliferation in postmenopausal women. [2002.03]
OBJECTIVE: We investigated the effects of 2-year transdermal continuous combined estradiol (0.025 mg/day) and norethisterone acetate (0.125 mg/day) (Estragest TTS) on bleeding and on the endometrium... CONCLUSIONS: A continuous combined transdermal patch delivering 0.025 mg estradiol/day and 0.125 mg norethisterone acetate/day provided good endometrial protection. The dose maintained a consistently high rate of amenorrhea in postmenopausal women.

Comparison between 1 year oral and transdermal oestradiol and sequential norethisterone acetate on circulating concentrations of leptin in postmenopausal women. [2001.08]
BACKGROUND: Oral and transdermal postmenopausal hormone replacement therapy (HRT) affects lipid and glucose metabolism differently, which is of significance in the release of leptin by adipocytes. Moreover, oestrogen and progesterone can stimulate leptin secretion in women of reproductive age. Therefore, we compared the effects of oral and transdermal oestrogen plus progestin regimen on plasma leptin in 38 healthy postmenopausal women with normal body mass index (BMI), who wished to use HRT to control incapacitating climacteric symptoms... CONCLUSION: Leptin is an unsuitable factor to detect oestradiol + NETA-induced metabolic changes in postmenopausal women.

more studies >>

Clinical Trials Related to Combipatch (Estradiol / Norethindrone)

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions [Completed]
The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0. 5 mg versus the reference Activella® (1 mg estradiol/0. 5 mg norethindrone acetate) Tablets under fasting conditions.

Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fed Conditions [Completed]
The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0. 5 mg versus the reference Activella® (1 mg estradiol/0. 5 mg norethindrone acetate) Tablets under fed conditions.

Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen [Not yet recruiting]

Endometrial Safety Study [Completed]

Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089) [Completed]
Tibolone has been registered for treatment of menopausal symptoms. It is, however, not known what the effects are of tibolone in postmenopausal women diagnosed with sexual dysfunction. This is important because there is currently no approved treatment of libido problems in postmenopausal women. Therefore, the primary aim of this study was to compare the effects of tibolone with an estrogen/progestogen skin patch in postmenopausal women diagnosed sexual dysfunction.

more trials >>

Reports of Suspected Combipatch (Estradiol / Norethindrone) Side Effects

Product Adhesion Issue (5)Hot Flush (4)Breast Mass (4)Breast Tenderness (4)Breast Cyst (3)Malaise (3)Breast Cancer (3)Incorrect Dose Administered (3)Pain (2)Headache (2)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Combipatch has an overall score of 5.50. The effectiveness score is 8 and the side effect score is 7. The scores are on ten point scale: 10 - best, 1 - worst.
 

Combipatch review by 51 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Menopause
Dosage & duration:   50/250 (dosage frequency: perscribed 2x per week) for the period of 6 months and still taking
Other conditions:   Reynauds Syndrome
Other drugs taken:   Multi-vitamin, calcium
  
Reported Results
Benefits:   Patient complaints prior to drug were menopause related. Inability to sleep, hot flashes, night sweats, lack of concentration (which may have been intensified by lack of sleep), loss of elasticity in the skin. Although the use of the patch has not helped improve my skin (I didn't expect it to) almost immediately sleep was restored, night sweats stopped, and concentration ability returned, although not as completely as pre-menopause.
Side effects:   The package insert warns of serious side effects such as breast cancer, cancer of the uterus, stroke, heart attack, blood clots and dementia. I had been one determined to go through menopause without the use of any hormones. However, after trying every over the counter, holistic, and wives tale cure for 5 years with no success, I wanted RELIEF. After consulting every possible option, weighing the side effects of each one carefully, the CombiPatch was the one settled upon. I am pleased to say I haven't had one side effect of the drug beyond a sticky spot left by the patch's adhesive. Granted, it has only been 6 months since beginning treatment but the benefits and quality of daily life restored have far outweighed the risks.
Comments:   It is, to my understanding, the smallest dosage available at 50/250 and my doctor suggested I even try applying once, rather than twice per week to see if that was enough to handle my symptoms. It was. The patch is so easy. I only have to remember once per week to change it. And on the rare occasion I forget, the patch loses some of its stickiness and reminds me! Honestly, for any woman truly suffering from constant problems like mine and don't fall into a high risk category, I would wholeheartedly recommend the patch.

 

Combipatch review by 54 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   menopause symptoms
Dosage & duration:   N/A (dosage frequency: monthly) for the period of 11 months
Other conditions:   None
Other drugs taken:   None
  
Reported Results
Benefits:   The benefits were to alleviate menopausal symptoms. It did a very good job at that.
Side effects:   Severe bleeding to the point that I was four days away from a hysterectomy. I stopped the HRT to prepare for the surgery and the bleeding subsided and eventually stopped. The hysterectomy was cancelled.
Comments:   The patch was worn on the arm.

See all Combipatch reviews / ratings >>

Page last updated: 2006-01-31

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