This was an open-label multicenter study to compare the cycle control and effect on well-being of two
oral contraceptives containing
gestodene and one containing
desogestrel. A total of 2419 healthy women < or = 41 years of age were randomized to receive
oral contraceptives containing monophasic
gestodene (
Minulet; n = 806, mean age 24.5 years), triphasic
gestodene (Tri-
Minulet; n = 808, mean age 24.6 years) or monophasic
desogestrel (
Mercilon; n = 805, mean age 24.6 years). Subjects were to participate in the study for up to 13 treatment cycles. A modified Moos Menstrual Distress Questionnaire was used to evaluate menstrual symptoms and to assess overall well-being. A total of 698 women were withdrawn from the study, 154 due to adverse events. Cycle control with
gestodene was superior to that with
desogestrel at almost all time points, particularly for
breakthrough bleeding and/or
spotting, which occurred significantly less frequently with
gestodene than with
desogestrel at cycles 1-7 and 9-11 (p < 0.05). Generally, the proportion of subjects with
breakthrough bleeding and/or
spotting was almost twice as great with
desogestrel as with
gestodene. The duration of
bleeding was not consistently different between the
gestodene and
desogestrel groups; however, the intensity of
bleeding was greater with
gestodene at all time points (p < 0.05). The latent period before withdrawal
bleeding was significantly longer for monophasic
gestodene at cycles 1-5 and 8-10 (p < 0.05). Treatment significantly improved overall well-being at cycles 6 and 9 with triphasic
gestodene and at cycle 13 with
desogestrel; however, no statistically significant differences among treatment groups in overall well-being scores or individual factors of well-being could be identified. All three treatments were well tolerated. The most common
drug-related adverse events were
headache (14.2%),
breast pain (6.2%),
nausea (4.1%),
metrorrhagia (3.9%) and
abdominal pain (3.5%). The incidence of adverse events in all treatment groups was similar, with the exception of
metrorrhagia, which occurred in more patients in the
desogestrel group than in the
gestodene treatment groups (p < 0.05).