Clinical Trial Information

Despite Being so Small, CombiPatch Provides Controlled, Sustained Release of Estradiol over 3 ½ days

Hormone Delivery Chart
  • Average steady-state estradiol serum concentrations of 45 pg/mL to 50 pg/mL

  • Estradiol levels have minimal peak-to-trough fluctuations1,2
Offers Individualized HT

Two Dosing Options:
  • 0.05/0.14 mg/day

  • 0.05/0.25 mg/day appropriate for patients who require more progestin
Two Approved Regimens:
  • Continuous combined regimen to achieve amenorrhea

  • Continuous cyclic regimen for predictable monthly bleed
CombiPatch Prescribing Information PDF

Estrogens and progestins should not be used for the prevention of cardiovascular disease or 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.

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 MPA relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Other doses of oral conjugated estrogens with MPA, 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 progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Estrogens and estrogens/progestins combined should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism, or history of these conditions; active or recent arterial thromboembolic disease; liver dysfunction or disease; or known or suspected pregnancy.

In clinical trials with CombiPatch, the most common side effects were breast pain, dysmenorrhea, and headache.

CombiPatch is indicated for women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause, and moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

1Adapted from Pentikis HS, Mullin ME, Howard M, et al. Evaluation of the bioavailability and dose proportionality of three formulations of a combination estrogen and progestin adhesive-based matrix transdermal delivery system. Curr Ther Res Clin Exp 1998;59:681-691.

2CombiPatch Prescribing Information. Novartis Pharmaceuticals Corporation. 2005.



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Available by prescription only.

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