Comparison of the local tolerability and adhesion of a new matrix system (Menorest) for estradiol delivery with an established transdermal membrane system (Estraderm TTS).
OBJECTIVE
To compare the local tolerability and adhesion of two transdermal systems for estradiol delivery, an established membrane system (Estraderm TTS 50) and a new matrix system (Menorest).


METHODS
275 healthy female subjects participated in this two-centre, open-label, within subject comparative study. Subjects received twice-weekly application of one placebo reservoir to the right abdomen and buttock and one matrix to the left abdomen and buttock for 21 days (wearing 4 patches simultaneously). Skin irritation, pruritus (by direct questioning) and adhesion were assessed at each patch change using rating scales.


RESULTS
Overall the two systems showed comparable local tolerability and adhesion assessed by 1590 readings for each system type on buttocks and abdomen. Skin irritation occurred less frequently with Estraderm TTS than Menorest on both buttocks (11.9% vs. 15.9%) and abdomen (13.7% vs. 15.9%). The incidence of pruritus was low for both systems with over 90% of applications on buttocks and 88% on abdomen being associated with no pruritus at all. Mild pruritus was seen slightly more frequently with Estraderm TTS than Menorest on both buttock (4.8% vs. 3.3%) and abdomen (7.8% vs. 2.8%). Similar adhesion was seen for both systems on the buttocks although the incidence of patches falling off was slightly lower with Estraderm TTS compared to Menorest (8.9% vs. 13.1%). On the abdomen the pattern was reversed with slightly better adhesion for Menorest.


CONCLUSIONS
The results suggest that there are no significant clinically relevant differences between the local tolerability and adhesion of an established membrane system for estradiol delivery (Estraderm TTS) and a newly introduced matrix system (Menorest).
Erianne
J A
JA
Leo Winter Associates, Inc., Manalapan, FL 33462-4752, USA.
Winter
L
L
D000005:Abdomen; D000268:Adhesiveness; D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D002081:Buttocks; D003875:Drug Eruptions / Q000209:etiology; D004958:Estradiol / Q000008:administration & dosage* / Q000009:adverse effects; D015914:Estrogen Replacement Therapy / Q000295:instrumentation*; D005260:Female; D006801:Humans; D015994:Incidence; D008567:Membranes, Artificial; D008875:Middle Aged; D010919:Placebos; D011537:Pruritus / Q000209:etiology
D008567:Membranes, Artificial; D010919:Placebos; D004958:Estradiol