Efficacy, safety and acceptability of a seven-day, transdermal estradiol patch for estrogen replacement therapy.

ABSTRACT

OBJECTIVES: To evaluate the efficacy, safety and acceptability of a seven-day, transdermal estradiol patch, in the treatment of menopausal symptoms. DESIGN: Open-label trial. SETTING: Hat Yai Regional Hospital, Thailand. SUBJECTS: Hysterectomized women with surgical or natural menopause. METHOD: The clients received a 12.5 cm2 matrix patch, containing 3.9 mg of estradiol delivering 0.05 mg/day, once a week for six months. The efficacy, safety, and acceptability were evaluated at the end of 1-, 3- and 6-months. RESULTS: Six-month responses were analyzed among 50 enrolled patients. The mean estradiol level/Follicle Stimulating Hormone/Lutienizing Hormone were 27.88/70.03/31.19, 44.08/53.37/26.86, and 42.43/48.53/24.39 pg/ml, mIU/L, mIU/L at admission, 1- and 3-months, respectively. The average climacteric score was 27.18, 16.60, 12.78, and 12.18 at admission, 1-, 3- and 6-month, respectively. At least 94 per cent of patches were not dislodged more than one quarter. The most common skin irritation was itching, followed by erythema, vesicle, and burning sensation. The patches were generally well tolerated, and acceptability was satisfactory. CONCLUSION: Transdermal estradiol patch effectively reduced the severity of menopausal symptoms, measured by modified climacteric score. Adhesion was found to be excellent. In actual clinical practice, the transdermal patch should be appropriately introduced to tolerant users.