Efficacy of the low-dose combined oral contraceptive chlormadinone acetate/ethinylestradiol: physical and emotional benefits.
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 >or=25 years of age.


METHODS
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 >or=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<or=.001); women with the respective preexisting symptoms may, therefore, benefit from CMA/EE contraceptive treatment. Further research is warranted.
Heskamp
Marie-Luise S
ML
Medical Department, Grünenthal GmbH, 52099 Aachen, Germany. marie-luise.heskamp@grunenthal.com
Schramm
Georg A K
GA
D002715:Chlormadinone Acetate / Q000627:therapeutic use*; D003268:Contraception Behavior; D003277:Contraceptives, Oral, Combined / Q000627:therapeutic use*; D004997:Ethinyl Estradiol / Q000627:therapeutic use*; D005260:Female; D005858:Germany; D006801:Humans; D010349:Patient Compliance; D017060:Patient Satisfaction; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies
D003277:Contraceptives, Oral, Combined; D002715:Chlormadinone Acetate; D004997:Ethinyl Estradiol