1. Evaluation of irritation and sensitisation of two 50 μg/day oestrogen patches
- Author
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Anita Maric, Liane Laurin, Erhard Quebe-Fehling, John Toole, Patricia Ibarra de Palacios, Barb Fath, Monique Giguere, and Stewart S. Silagy
- Subjects
Adult ,medicine.medical_specialty ,Erythema ,medicine.drug_class ,medicine.medical_treatment ,Administration, Cutaneous ,medicine.disease_cause ,Severity of Illness Index ,General Biochemistry, Genetics and Molecular Biology ,law.invention ,Randomized controlled trial ,law ,Internal medicine ,Humans ,Medicine ,Aged ,Transdermal ,Chemotherapy ,Estradiol ,business.industry ,Estrogen Replacement Therapy ,Obstetrics and Gynecology ,Middle Aged ,medicine.disease ,Postmenopause ,Menopause ,Treatment Outcome ,Endocrinology ,Estrogen ,Anesthesia ,Toxicity ,Female ,Irritation ,medicine.symptom ,business - Abstract
Objectives: To comparatively assess the irritation and sensitisation of the Estradot® transdermal oestrogen patch, in healthy postmenopausal women, using the Menorest® transdermal oestrogen patch, as a comparator. Methods: In an open-label, single-centre, randomised, active-treatment, within-patient controlled study, 208 healthy postmenopausal women, age range 40–70 years, received and completed simultaneous treatment with a 5 cm2 (50 μg/day) oestradiol patch (Estradot) and a 14.5 cm2 (50 μg/day) oestradiol patch (Menorest). The treatment was given for 72 h, then 96 h, for eight successive applications during an induction phase, and for 72 h during a challenge phase. There was a 14-day resting period between phases. Skin irritation (measured by erythema on a scale of 0–4), topical sensitisation, patch adherence and local skin reaction, were assessed and recorded immediately before or after removal of each patch, as appropriate. Results: Most patients experienced a significant difference in irritation with Menorest than with Estradot (P
- Published
- 2002
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