Cycle control in women using an oral contraceptive containing gestodene
60mcg/ethinylestradiol 15mcg
I.C. Barbosa (1), D. Faggion Jr (2), C. Isaia Filho (3), E.C. Baracat
(4), R. Acquaroli (5)
Department of Obstetrics, Gynecology and Human Reproduction, Federal
University of Bahia, Salvador, Bahia, Brazil (1); DFJ Clinica Médica, São
Paulo, Brazil (2); Centro de Medicina Reprodutiva Dr. Carlos Isaia Filho, Porto
Alegre, Brazil (3); São Paulo Hospital, Federal University of São Paulo,
Brazil (4); Wyeth Pharmaceutical, São Paulo, Brazil (5)
Objective: To evaluate cycle control in a group of healthy women under
40 years of age in use of a ultra-low dose oral contraceptive containing
gestodene 60mcg/ethinylestradiol 15mcg (Minesse).
Design and Methods: This was an open, non-comparative, multicenter
study carried out in four sites in Brazil, involving 163 women aged 18–39
years (mean 25+5 years). Patients were treated for six months with an
oral regimen of gestodene 60mcg/ ethinylestradiol 15mcg daily from day 1–24 of
the menstrual cycle, followed by a 4-day pill-free interval from day 25–28 of
the cycle. All patients kept a menstrual diary throughout the study and were
evaluated at baseline and after 3 and 6 months of contraceptive pill use.
Student’s t test for paired values was used to analyze the length of the
menstrual cycle and the duration of menstrual bleeding. The Chi-square test was
used to analyze the intensity of menstrual bleeding.
Results: A total of 146 women completed the study. The length of the
menstrual cycle and duration of menstrual bleeding was significantly shorter in
the 3rd and 6th month of pill use when compared to baseline. Mean cycle length
decreased from 29.4+1.1 days at baseline to 27.9+1.8 days at month
3 (p<0.01) and to 27.9+1.6 at month 6 (p<0.01). Mean duration of bleeding decreased from 4.4+2.3 days at baseline to 3.8+1.5 days
both at month 3 (p<0.01) and month 6 of treatment (p<0.05). Although not significant, the intensity of menstrual flow decreased by the sixth month of study in 49.24% of users. The incidence of breakthrough bleeding in this study population was 32.7%. However, approximately 40% of all episodes of breakthrough bleeding occurred during the first treatment cycle, decreasing consistently throughout the subsequent cycles. By the sixth treatment cycle the occurrence of breakthrough bleeding was 8.6%. The incidence of amenorrhea and delayed menstruation was 7.4 and 4.3% respectively.
Conclusions: The findings of the present study are in agreement with
other reports showing that this ultra-low dose oral contraceptive, in a 24-day
regimen, has the beneficial effect of reducing both the intensity and duration
of menstrual bleeding, offering good cycle control with a consistent decrease in
the occurrence of breakthrough bleeding with duration of use.
