A MULTICENTER RANDOMIZED PARALLEL-GROUP STUDY COMPARING A NEW ESTRADIOL MATRIX PATCH AND A REGISTERED RESERVOIR PATCH

A new transdermal therapeutic system has been developed, in which estr adiol is dispersed in the adhesive matrix. Gynecologists from 10 Swedi sh cities recruited 265 healthy women >50 years of age with climacteri c complaints into a randomized trial. The objectives of the study were to compare the effects of treatment with the new matrix system and a registered reservoir system. Both patches administer 50 mu g/day of 17 -beta-estradiol transdermally. Significantly fewer women on the new pa tch noted erythema, itching, rubbing of the patch on clothes, rustling of the patch, and problems removing the protective lining. The matrix patch also adapted better to the skin and fell off in significantly f ewer cases than the reservoir patch. The physician was unaware of the treatment allocated to the patient. Clinic visits were scheduled durin g treatment-free periods. Patch sites were examined by a study nurse, independently of the clinician. Overall assessment of effectiveness by the investigators favored the new matrix patch, even though efficacy variables suggested equivalence.