Treatment of moderate acne vulgaris using a combined oral contraceptive containing ethinylestradiol 20 μg plus drospirenone 3mg administered in a 24/4 regimen: a pooled analysis

Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):171-5. doi: 10.1016/j.ejogrb.2010.12.027. Epub 2011 Feb 2.


Objective: To investigate the effects of an ethinylestradiol (EE) 20 μg/drospirenone (drsp) 3mg combined oral contraceptive (COC) administered in a 24/4 regimen (24 active tablets/4 inert tablets per cycle) for the treatment of moderate acne vulgaris, based on a pooled analysis of two identically designed US studies.

Study design: Healthy females (n=893) aged 14-45 years with moderate facial acne were randomised to EE 20 μg/drsp 3mg COC (n=451) or placebo (n=442) for six cycles. Primary outcome measures were mean percent change in acne lesion counts and the investigators' assessment of acne from baseline to endpoint.

Results: There were significantly greater reductions in the mean percent change from baseline to endpoint in inflammatory, non-inflammatory and total lesion counts in the EE 20 μg/drsp 3mg 24/4 COC group compared with the placebo group (P<0.0001). The odds of women in the EE 20 μg/drsp 3mg 24/4 COC group having 'clear' or 'almost clear' skin as rated by the investigators at endpoint were around three-fold greater than in the placebo group (odds ratio 3.41; 95% CI: 2.15-5.43; P<0.0001).

Conclusions: A low-dose COC containing EE 20 μg/drsp 3mg (24/4) more effectively reduced acne lesions than placebo and demonstrated greater improvement in the investigator global assessment of acne.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Adolescent
  • Adult
  • Androstenes / administration & dosage
  • Androstenes / therapeutic use*
  • Contraceptives, Oral, Combined / administration & dosage
  • Contraceptives, Oral, Combined / therapeutic use*
  • Double-Blind Method
  • Estrogens / administration & dosage
  • Estrogens / therapeutic use
  • Ethinyl Estradiol / administration & dosage
  • Ethinyl Estradiol / therapeutic use*
  • Female
  • Humans
  • Progestins / administration & dosage
  • Progestins / therapeutic use
  • Severity of Illness Index
  • Young Adult


  • Androstenes
  • Contraceptives, Oral, Combined
  • Estrogens
  • Progestins
  • Ethinyl Estradiol
  • drospirenone