Mulders
JA.Freidrich-Ebert-Krankenhaus, Neumunster, Germany.
Objectives:
Poor cycle control and tolerability can be reasons for
irregular pill intake. This study compared the tolerability
of two low-dose oral contraceptives and their effect on
cycle control.
Methods:
In this open, group-comparative, randomized multicenter
trial in Germany and the Netherlands, women received either
20 microg ethinylestradiol plus 150 microg desogestrel
(20EE/DSG; n = 500) or 20 microg ethinylestradiol plus 100
microg levonorgestrel (20EE/LNG; n = 498) for six treatment
cycles. Cycle control, dysmenorrhea and premenstrual
syndrome (PMS) were assessed using diary cards. Tolerability
was assessed using the self-administered questionnaires
Psychological General Well-Being Index (PGWBI) and the
Profile of Mood States (POMS). Acne was assessed by
objective (acne counts) and subjective (no, moderate, mild,
severe) acne scoring of the facial area at baseline and
treatment cycles 1, 3 and 6.
Results:
A total of 404 (78.1%) and 384 (75.3%) women in the 20EE/DSG
and 20EE/LNG groups, respectively, completed the trial. The
occurrence rate of irregular bleeding and spotting was
statistically significantly higher with 20EE/LNG than with
20EE/DSG (0.18 vs. 0.13; p< 0.05). The mean number of
bleeding-spotting days per cycle was statistically
significantly higher with 20EE/LNG than with 20EE/DSG (0.63
vs. 0.48; p< 0.05). Early withdrawal bleeding was more
frequent with 20EE/LNG (0.15 vs. 0.08; p< 0.005), whereas
continued withdrawal bleeding was more frequent with 20EE/DSG
(0.32 vs. 0.45; p< 0.001); absence of withdrawal bleeding
was comparable (0.06 vs. 0.04, respectively). Thirteen
subjects in the 20EE/LNG group and three in the 20EE/DSG
group discontinued due to unacceptable bleeding (p< 0.05).
Dysmenorrhea and PMS decreased comparably in both groups.
There were no differences between groups for the mean total
scores of PGWBI or POMS at all time-points. Fewer acne
lesions were counted with 20EE/DSG vs. 20EE/LNG after six
cycles (p< 0.05). The subjective acne scores supported this
finding.
Conclusions:
20EE/DSG provided better cycle control than 20EE/LNG with
less treatment discontinuation due to unacceptable bleeding.
There were no apparent differences between the two groups
regarding tolerability and quality of life. There was less
acne with 20EE/DSG.
