A comparison of cycle control and effect on well-being of monophasic gestodene-, triphasic gestodene- and monophasic desogestrel-containing oral contraceptives

This was an open-label multicenter study to compare the cycle control and e ffect on well-being of two oral contraceptives containing gestodene and one containing desogestrel. A total of 2419 healthy women less than or equal t o 41 years of age were randomized to receive oral contraceptives containing monophasic gestodene (Minulet(R); n = 806, mean age 24.5 years), triphasic gestodene (Tri-Minulet(R); n = 808, mean age 24.6 years) or monophasic des ogestrel (Mercilon(R); n = 805, mean age 24.6 years). Subjects were to part icipate in the study for up to 13 treatment cycles. A modified Moos Menstru al Distress Questionnaire was used to evaluate menstrual symptoms and to as sess overall well-being. A total of 698 women were withdrawn from the study, 154 due to adverse even ts. Cycle control with gestodene was superior to that with desogestrel at a lmost all time points, particularly for breakthrough bleeding and/or spotti ng, which occurred significantly less frequently with gestodene than with d esogestrel 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 gre at with desogestrel as with gestodene. The duration of bleeding was not con sistently 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 lon ger for monophasic gestodene at cycles 1-5 and 8-10 (p < 0.05). Treatment s ignificantly improved overall well-being at cycles 6 and 9 with triphasic g estodene and at cycle 13 with desogestrel; however, no statistically signif icant differences among treatment groups in overall well-being scares or in dividual factors of well-being could be identified. All three treatments we re well tolerated. The most common drug-related adverse events were headach e (14.2%), breast pain (6.2%), nausea (4.1%), metrorrhagia (3.9%) and abdom inal pain (3.5%). The incidence of adverse events in all treatment groups w as similar, with the exception of metrorrhagia, which occurred in move pati ents in the desogestrel group than in the gestodene treatment groups (p < 0 .05).