Transdermal Preference

The Form She Preferred Didn’t Come in a Pill Bottle1

Placebo patches or placebo pills

Methodology

A double-dummy study using a daily placebo pill and a semiweekly placebo patch assessed women’s preferences regarding continuous use of a transdermal DOT Matrix™ placebo patch or daily intake of an oral placebo tablet. After 4 weeks of administration, the 186 patients involved were asked to evaluate their preferences for patches or pills. This study did not evaluate efficacy or safety.
  • 98 patients (N=186) preferred the twice-weekly DOT Matrix™ placebo patch over 60 patients (N=186) who preferred daily placebo pills

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.

1Simon J, Rogers P, Ragavan V, Ibarra de Palacios P. Menopausal women prefer patches to pills for hormone replacement therapy. Data on file. Noven Pharmaceuticals 2003.

Dot Matrix™ is a trademark of Noven Pharmaceuticals, Inc.


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Available by prescription only.

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