Efficacy, Safety and Acceptability of a Seven-Day, Trans dermal Estradiol Patch for Estrogen Replacement Therapy
TAPNARONG JARUPANICH, MD*, SURACHAI LAMLERTKITTIKUL, MD*, VERAPOL CHANDEYING, MD**
Affiliation : * Department of Obstetrics and Gynecology, Hat Yai Regional Hospital, Songkhla 90 l 00, ** Department of Obstetrics and Gynecology, Faculty of Medicine, Prince of Songkla University, Songkhla 90110, Thailand. ® Climara®, Schering
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 Ya i 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 deliver ing 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 irrita tion 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 clini cal practice, the transdermal patch should be appropriately introduced to tolerant users.
Keywords : Transdermal Estradiol, Estrogen Replacement Therapy, Efficacy, Safety, Acceptability
