A comparative assessment of ORTHO EVRA™/EVRA™ to placebo patch effects on body weight.

Abstract

Objective: To evaluate the effect on body weight of a transdermal contraceptive, which delivers norelgestromin 150 μg daily and ethinyl estradiol 20 μg daily to systemic circulation.Design: A transdermal contraceptive (n = 92) was directly compared to an identical placebo patch (n = 44) in a 9-cycle, randomized, double-blind, parallel-group trial of healthy women.Materials/Methods: Body weight was measured at baseline and at the final visit. The distribution of percentage body weight decreases/increases across 5 categories was determined (10% decrease, 5%–10% decrease, within 5%, 5%–10% increase, >10% increase). A Wilcoxon-Mann-Whitney test was used to determine if the distribution of body weight changes was comparable between the transdermal contraceptive and placebo.Results: The distribution of body weight changes was not significantly different between the transdermal contraceptive and placebo, with increases of >10% observed in a higher percentage of placebo subjects than transdermal contraceptive subjects.Mean increases from baseline were 0.8 kg (1.2% increase) for the transdermal contraceptive group and 0.6 kg (0.9% increase) for the placebo group. The distribution of percentage body weight decreases/increases for the transdermal contraceptive group was the same as that for the 3088 women who received the transdermal contraceptive for 6 to 13 cycles in the 3 contraception studies, with only 2.2% of subjects in the >10% increase category and a mean increase of 0.3 kg.Distribution of body weight changes over 9 cycles. Tabled 1Weight changeORTHO EVRA™, N (%) of subjectsPlacebo, N (%) of subjects>10% decrease01 (2.3)5%–10% decrease2 (2.2)2 (4.5)Within 5%80 (87.0)36 (81.8)5%–10% increase8 (8.7)3 (6.8)>10% increase2 (2.2)2 (4.5) Open table in a new tab Conclusions: ORTHO EVRA™ had no overall effect on body weight over 9 cycles when compared to placebo in a randomized, double-blind, parallel-group study.Supported by: The R.W. Johnson Pharmaceutical Research Institute. Objective: To evaluate the effect on body weight of a transdermal contraceptive, which delivers norelgestromin 150 μg daily and ethinyl estradiol 20 μg daily to systemic circulation. Design: A transdermal contraceptive (n = 92) was directly compared to an identical placebo patch (n = 44) in a 9-cycle, randomized, double-blind, parallel-group trial of healthy women. Materials/Methods: Body weight was measured at baseline and at the final visit. The distribution of percentage body weight decreases/increases across 5 categories was determined (10% decrease, 5%–10% decrease, within 5%, 5%–10% increase, >10% increase). A Wilcoxon-Mann-Whitney test was used to determine if the distribution of body weight changes was comparable between the transdermal contraceptive and placebo. Results: The distribution of body weight changes was not significantly different between the transdermal contraceptive and placebo, with increases of >10% observed in a higher percentage of placebo subjects than transdermal contraceptive subjects. Mean increases from baseline were 0.8 kg (1.2% increase) for the transdermal contraceptive group and 0.6 kg (0.9% increase) for the placebo group. The distribution of percentage body weight decreases/increases for the transdermal contraceptive group was the same as that for the 3088 women who received the transdermal contraceptive for 6 to 13 cycles in the 3 contraception studies, with only 2.2% of subjects in the >10% increase category and a mean increase of 0.3 kg. Distribution of body weight changes over 9 cycles. Tabled 1Weight changeORTHO EVRA™, N (%) of subjectsPlacebo, N (%) of subjects>10% decrease01 (2.3)5%–10% decrease2 (2.2)2 (4.5)Within 5%80 (87.0)36 (81.8)5%–10% increase8 (8.7)3 (6.8)>10% increase2 (2.2)2 (4.5) Open table in a new tab Conclusions: ORTHO EVRA™ had no overall effect on body weight over 9 cycles when compared to placebo in a randomized, double-blind, parallel-group study. Supported by: The R.W. Johnson Pharmaceutical Research Institute.