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.
A prospective, non-interventional, observational study of 3772 women over six cycles was conducted in 303 office-based gynecological centers throughout Germany.
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.
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.
To read this article in full you will need to make a payment
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:Subscribe to Contraception
Already a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
Society of Consumer Goods Research (Gesellschaft f��r Konsumg��terforschung). Survey on prevalence of depressive mood and other psychical disorders in German women. Dec 2005���Jan 2006. unpublished.
- A comparative study of monophasic oral contraceptives containing either drospirenone 3 mg or levonorgestrel 150 microg on premenstrual symptoms.Contraception. 2005; 71: 1-7
- Influence of chlormadinone acetate on dysmenorrhea and other cycle-related complaints (original in German language).Gyne. 2008; 8: 219-225
- Contraceptive efficacy and tolerability of chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg (Belara��).Clin Drug Invest. 2002; 22: 221-231
- A 12-month evaluation of the CMA-containing oral contraceptive Belara��: efficacy, tolerability and anti-androgenic properties.Contraception. 2003; 67: 305-312
- Switching hormonal contraceptives to a chlormadinone acetate-containing oral contraceptive. The Contraceptive Switch Study.Contraception. 2007; 76: 84-90
- Efficacy and safety of the new antiandrogenic oral contraceptive Belara��.Contraception. 1998; 57: 103-109
- Acne resolution rates: results of a single-blind, randomised, controlled, parallel phase III trial with EE/CMA (Belara��) and EE/LNG (Microgynon��).Dermatology. 2001; 203: 38-44
- Effect of an oral contraceptive with chlormadinone acetate on depressive mood. Analysis of data from four observational studies.Clin Drug Invest. 2008; 28: 783-791
- Premenstrual syndrome.American College of Obstetricians and Gynecologists (ACOG), Washington (DC)2000 ([Apr. 9 (ACOG practice bulletin; no. 15) (reaffirmed 2005)])
- Premenstrual syndrome: an update on definitions, diagnosis and management.Adv Psychiatr Treat. 2001; 7: 469-477
- Cardiovascular risks associated with low-dose combined oral contraceptives.Ther Umsch. 2001; 58: 564-569
- Treatment of premenstrual dysphoric disorder with a new drospirenone-containing oral contraceptive formulation.Contraception. 2005; 72: 414-421
- Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder.Obstet Gynecol. 2005; 106: 492-501
- An update on GABAA receptors.Brain Res Rev. 1999; 29: 196-217
- Neuroactive steroids: their mechanism of action and their function in the stress response.Acta Physiol Scand. 1999; 167: 181-188
- Gonadal steroids in the treatment of mood disorders.Psychosom Med. 1999; 61: 676-697
Published online: July 23, 2009
Accepted: June 11, 2009
Received in revised form: May 19, 2009
Received: November 5, 2008
© 2010 Elsevier Inc. Published by Elsevier Inc. All rights reserved.