Abstract
Background
This study investigated the effects of the low-dose combined oral contraceptive (COC)
2.0 mg chlormadinone acetate (CMA)/0.03 mg ethinylestradiol (EE) (Belara��, Balanca��)
on cycle-related physical and emotional disorders in women ���25 years of age.
Study Design
A prospective, non-interventional, observational study of 3772 women over six cycles
was conducted in 303 office-based gynecological centers throughout Germany.
Results
CMA/EE provided high contraceptive efficacy with a Pearl index of 0 (95% confidence
interval=0.00���0.22) and was generally well tolerated, with no statistically significant
weight changes during the observation period (p=.147). CMA/EE intake resulted in a
statistically significant improvement in cycle-related physical and emotional symptoms,
with a 67% overall reduction in sum score for number and intensity of cycle-related
symptoms per patient.
Conclusions
The results of this study in women ���25 years of age support previous findings that
2.0 mg CMA/0.03 mg EE is an effective low-dose COC, with an excellent tolerability
profile, with the additional benefits of significantly reducing both cycle-related
physical and emotional symptoms (p���.001); women with the respective preexisting
symptoms may, therefore, benefit from CMA/EE contraceptive treatment. Further research
is warranted.
Keywords
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Article info
Publication history
Published online: July 23, 2009
Accepted:
June 11,
2009
Received in revised form:
May 19,
2009
Received:
November 5,
2008
Identification
Copyright
© 2010 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
