A comparison of cycle control and effect on well-being of monophasic gestodene-, triphasic gestodene- and monophasic desogestrel-containing oral contraceptives. Gestodene Study Group.
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 A total of 698 women were withdrawn from the study, 154 due to adverse events.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).
Bruni
V
V
Dipartimento di Ginecologia, Perinatologia e Reproduzione Umana, Università degli Studi di Firenze, Italy.
Croxatto
H
H
De La Cruz
J
J
Dhont
M
M
Durlot
F
F
Fernandes
M T
MT
Andrade
R P
RP
Weisberg
E
E
Rhoa
M
M
D000293:Adolescent; D000328:Adult; D000339:Affect / Q000187:drug effects*; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects; D017135:Desogestrel / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects*; D009652:Norpregnenes / Q000008:administration & dosage* / Q000009:adverse effects; D017060:Patient Satisfaction; D045167:Progesterone Congeners / Q000008:administration & dosage* / Q000009:adverse effects; D014592:Uterine Hemorrhage / Q000139:chemically induced
D003280:Contraceptives, Oral, Synthetic; D009652:Norpregnenes; D045167:Progesterone Congeners; C033273:Gestodene; D017135:Desogestrel