The European Journal of Contraception and Reproductive Health Care 2002;7:238–243

Improvement of quality of life in

women using a low-dose
desogestrel-containing contraceptive:
results of an observational clinical
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evaluation
U. Ernst, L. Baumgartner*, U. Bauer† and G. Janssen‡
Organon Germany, Munich; *Private Clinic, Mühldorf; †Private Clinic, Nurenberg; ‡Private Clinic, Munich, Germany

ABSTRACT Objective To assess the influence of an oral contraceptive (OC) containing 20 mg

ethinylestradiol and 150 mg desogestrel on quality of life and subjective symptoms.
Methods In this multicenter observational evaluation performed in Germany, 3679
first-time OC users were included. They were treated by 623 physicians. The women
For personal use only.

completed quality of life questionnaires (Q-LES-Q) at baseline and after three treatment
cycles.
Results The mean age of users (± SD) was 22.5 ± 7.1 years, with 47% of the women
aged between 15 and 20 years. Half of the women reported skin problems at inclusion and, of
these, 36% reported disappearance of the problems after three treatment cycles. Most women
suffering from subjective symptoms (headache, nausea, nervousness, breast tenderness and
depressive moods) at baseline reported improvements (57–71%) in their symptoms after
using the OC for three cycles. Adverse events were reported by 4% of users; the most
frequently reported were bleeding irregularities (1.7%). The total quality-of-life score and all
its 13 individual items improved significantly (p < 0.0001), with the largest improvements
in sex life and mood. Almost all (94%) women were either very satisfied or satisfied with
the medication.
Conclusion The OC containing ethinylestradiol and desogestrel significantly improved the
quality of life and subjective symptoms. The OC was well tolerated by first-time users.

K E Y W O R D S Quality of life, Oral contraception, Desogestrel

INTRODUCTION

Quality of life and general well-being are themselves about the extent to which the overall quality of life
important, but they can also considerably affect user and well-being of OC users are affected by the
compliance and consequently the effectiveness of an balance between the potential benefits (such as reduced
oral contraceptive (OC). Little is known, however, menstrual bleeding irregularities and iron deficiency,

Correspondence: Dr U. Ernst, Organon Germany, Mittenheimer Straße 62, Oberschleissheim 85764, Germany

MS 2245
Received 15–10–02
ORIGINAL AR TICLE 238 Accepted 20–11–02
 Quality of life with a low-dose desogestrel-containing oral contraceptive
control over the menstrual cycle, reduction of
dysmenorrhea and premenstrual syndrome, and
reduced fear of pregnancy) and the potential adverse
effects (such as vulnerability to irritability, headache,
nausea and breast tenderness).
There is general agreement about the need to mini-
mize the estrogen dose in OCs in order to minimize
the risks of thrombotic complications and changes in
the hemostatic system 1–4. In addition, the subjective
side-effects of OCs such as headache, nausea, mood
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changes and breast tenderness are thought to be caused
mainly by the estrogen component5.
The development of the highly selective pro-
gestogen desogestrel, indicating a high affinity for
the progestogen receptor and a low affinity for the
androgen receptor, facilitated the reduction of
the estrogen component in OCs to 20 mg ethinyl-
estradiol per tablet6. The monophasic combination
preparation containing 20 mg ethinylestradiol and
150 mg desogestrel has a high contraceptive reliability
with a Pearl Index of 0.186. The preparation produces
good cycle control with shorter and lighter withdrawal
For personal use only.
bleeding7–9, is well tolerated, having no significant
effect on body weight and a low incidence of
subjective side-effects such as nausea, headache and
breast tenderness7,9. The low androgenic activity of
desogestrel may result in beneficial effects on problems
such as hirsutism and skin disorders when adminis-
tered in combination with ethinylestradiol6,10. The
results of a previous study in first-time users indicated
that the preparation significantly improved most
parameters of quality of life11.
The objectives of the current observational
evaluation were to assess the impact of 20 mg ethinyl-
estradiol plus 150 mg desogestrel on quality of life
and to collect information on the tolerability and
efficacy of the OC in a large number of patients
during normal daily use.
METHODS
Study population and medication
Young women requesting oral contraception (all
first-time users) were enrolled in this multicenter study
conducted in Germany, provided they did not have
any contraindications to the use of OCs and were
The European Journal of Contraception and Reproductive Health Care
Ernst et al.
not pregnant. Participants took MercilonÒ (N.V.
Organon, The Netherlands), a combination prepara-
tion containing 20 mg ethinylestradiol and 150 mg
desogestrel, for three or four cycles. Each cycle
consisted of 21 tablet-taking days followed by
7 pill-free days.
Assessments
At inclusion, each woman’s date of birth, weight,
medical history, blood pressure, known risk factors for
cardiovascular disease and concomitant medication
were recorded. To assess the incidence of facial skin
problems, the numbers of facial papules and pustules
were categorized as: 1–5, 6–10 and > 10. The inci-
dence and intensity of subjective symptoms were
recorded. Users were asked to complete a self-
administered questionnaire on 13 quality-of-life
items (Quality of Life Enjoyment and Satisfaction
Questionnaire, Q-LES-Q)12. The Q-LES-Q is
designed to enable investigators to easily obtain
sensitive measures of the enjoyment and satisfaction
experienced by subjects with a wide variety of mental
and medical disorders in various areas of daily
functioning. It has also previously been used to assess
satisfaction and quality of life in first-time OC users11.
All items were scored from 1 (very dissatisfied)
to 5 (very satisfied); hence, total scores could range
from 13 to 65.
At the end of the observation period, weight was
again recorded as well as the assessment of facial skin
problems and intensity of subjective symptoms. The
quality-of-life questionnaire was completed for the
second time. In addition, subjects were asked to give
an overall assessment of the OC. All adverse events
experienced during OC use and not present at base-
line as well as reasons for discontinuing the prescribed
OC, if applicable, were recorded.
Statistical analysis
Data validation and descriptive statistical analysis
were performed using the Statistic Analysis System
Software Package SAS, Version 6.12. Mean values
of quality of life scores were compared using the
Wilcoxon test.
239
 Quality of life with a low-dose desogestrel-containing oral contraceptive
RESULTS
A total of 3679 young women, with a mean age (± SD)
of 22.5 ± 7.1 years, were enrolled by 623 physicians.
Of these women, 47% were between 15 and 20 years
of age. The mean period of observation was 3.4 ± 0.7
cycles.
Two women discontinued the evaluation because
of pregnancy; one proved to be pregnant before
the start of treatment, while the other pregnancy was
due to user failure (irregular pill intake). No other
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pregnancies occurred throughout the study.
During the observation period, no clinically or
statistically significant weight increase was observed.
The mean weight (± SD) increased from 60.6 ± 9.4 kg
at inclusion to 61.0 ± 9.4 kg at the end of the evalua-
tion, a mean increase of 0.3 ± 1.6 kg.
Fifty-one per cent of the women reported skin
problems at inclusion and, of these, 36% reported dis-
appearance of the problems after three cycles of
OC use. The total number of users without skin
problems increased from 1809 (49%) at inclusion to
For personal use only.
2313 (63%) at the end of the evaluation, a relative
increase of 28%. A total of 722 users (39%) reported
an improvement in their skin condition, as indicated
by a decrease in the number of papules and/or
pustules (by category). Only 18 users (1%) reported
a worsening of their skin condition.
The majority of OC users who had subjective
symptoms at baseline reported improvements at cycle
3 (Table 1). Of the women who had complaints at
baseline (7.6% of the study population), 61% reported
improvement of nausea, 57% of headache, 62% of
nervousness, 71% of depressive moods and 59%
of breast tenderness.
During the observation period, 146 (4%) users
reported adverse events. The most frequent adverse
events experienced during OC use that were not
present at baseline were bleeding irregularities (in
1.7% of women), followed by headache (0.5%),
breast tenderness (0.5%), skin disorders (0.5%), weight
gain (0.4%), psychological problems (0.4%) and nausea
and vomiting (0.3%). Forty-five per cent of the
recorded adverse events were considered by the
investigators to be related to OC use. Five events
were considered serious, but none of these was
related to the use of the low-dose OC.
240
Ernst et al.
Table 1 Changes in subjective complaints during three
cycles of low-dose oral contraceptive use
Number and percentage of users
Improved No change Worse
Nausea (n = 551) 337 (61.2) 62 (11.3) 152 (27.6)
Headache (n = 1327) 759 (57.2) 377 (28.4) 191 (14.4)
Nervousness 696 (61.5) 360 (31.8) 76 (6.7)
(n = 1132)
Depressive moods 641 (70.6) 176 (19.4) 91 (10.0)
(n = 908)
Breast tenderness 856 (58.6) 234 (16.0) 371 (25.4)
(n = 1461)
n = total number of users with specified symptom at
inclusion
The Q-LES-Q was completed both at inclusion
and at the end of the observation period by 96.5%
of the women. Changes in the 13 different quality-of-
life items are shown in Figure 1. All post-evaluation
scores had improved statistically significantly from
baseline (p < 0.0001); the largest improvements were
seen in the satisfaction with sex life and the occurrence
of mood changes, followed by overall satisfaction,
general well-being, physical health and satisfaction
with daily life. The proportion of women with
total quality-of-life scores of £ 45 (indicative of
poor quality of life) dropped from 23.9% to 12.4%.
The proportion of women with total quality-of-
life scores of ³ 57 (indicative of good quality of life)
increased from 11.3% to 17.4% (Figure 2).
The overall assessment of the 20 mg ethinylestradiol
plus 150 mg desogestrel OC was that 94% of women
were either ‘very satisfied’ or ‘satisfied’ with using
the OC, whereas 4% of the women were ‘dissatisfied’
with its use.
After the observational period, 93% of the partici-
pants continued using the OC. The main reasons
for not continuing the method were ‘bleeding
irregularities’ (1.4%) and ‘no current need for contra-
ception’ (0.9%).
DISCUSSION
The women enrolled in the present observational
evaluation included a high proportion of adolescents
The European Journal of Contraception and Reproductive Health Care
 Quality of life with a low-dose desogestrel-containing oral contraceptive
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For personal use only.
Figure 1 Statistically significant changes in all quality-
of-life subscores during three cycles of low-dose oral
contraceptive use. A higher score indicates a better
quality of life (p < 0.0001 for all categories)
and young adults (approximately 50% of the study
population), which was not surprising since only
first-time users of OCs were included. The medical
history data show that the study population was other-
wise representative of normal OC users. The results
are consistent with those previously reported on the
high efficacy of this preparation6: one in-treatment
pregnancy was reported, which resulted from irregular
pill intake (user failure).
A large proportion (51%) of the women reported
skin problems at baseline. The low-dose OC facili-
tated a rapid onset of improvement of skin disorders
in a substantial number of these users (39%). Improve-
ment of facial skin problems with the use of a
preparation with a higher dose of ethinylestradiol
(30 mg) with desogestrel has been reported
previously13,14, but not with the 20-mg ethinylestradiol
The European Journal of Contraception and Reproductive Health Care
Ernst et al.
Figure 2 Changes in total quality-of-life score after
three cycles of low-dose oral contraceptive use. A
higher score indicates a better total quality of life
preparation. This positive effect may result from
an estrogen-induced reduction in androgen levels.
Ethinylestradiol induces a decrease in ovarian andro-
gen production, which is dose-dependent. Further-
more, it increases the level of sex hormone binding
globulin (SHBG), which in turn decreases the free
testosterone level. The very low androgenicity of
desogestrel may also contribute to the overall benefi-
cial effect on the skin15. Improvements in nausea,
headache, nervousness, depressive moods or breast
tenderness were also seen in more than half of women
reporting these symptoms at baseline. The improve-
ment in subjective symptoms with the 20 mg ethinyl-
estradiol plus 150 mg desogestrel combination
observed during normal daily usage is consistent with
those seen previously in clinical trials7,9,16–19.
The improvements in subjective symptoms are
reflected by the improvements in quality of life, as
assessed by the self-administered Q-LES-Q12. The
proportion of women with total quality-of-life scores
of £ 45, indicating a relatively poor quality of life,
decreased by almost 50%, and the proportion with
total scores of ³ 57, indicating a particularly good
quality of life, increased by more than 50%. In addi-
tion, statistically significant improvements were seen
in all 13 of the individual quality-of-life assessments.
The improvement in quality of life seen during
this evaluation is similar to that seen during an earlier
241
 Quality of life with a low-dose desogestrel-containing oral contraceptive
study with this OC11. In that smaller study, total
scores also improved and significant improvements
were seen for nine of the 13 individual items evaluated.
In the present evaluation, the largest improvements
were seen for sex life and mood changes, followed by
physical health, leisure time activities, general well-
being and overall satisfaction. In the earlier study11,
satisfaction with work/school activities, household
activities, leisure time activities and sex life improved
most, so the pattern of changes for the individual
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items used to assess quality of life was not entirely
consistent between the two studies. However, there
were some consistencies: sex life and satisfaction with
leisure time activities showed large increases in both
studies, and the four items showing the smallest
changes (social relationships, family relationships,
living situation and vision) were the same in both
studies. The improvement in mood seen in this
evaluation is consistent with the earlier study of
quality of life in users of this OC11, but is in contrast to
the results of earlier studies with other OCs, which
have generally shown a deterioration or no change
For personal use only.
in mood when first-time users began using a
contraceptive19–22.
The changes in individual aspects of sex life made a
major contribution to the improvement in quality of
life. It seems likely that other contributors were the
reduction in skin lesions and subjective complaints
such as breast tenderness, headache and nervousness, as
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