title: Comparison of two contraceptive pills containing drospirenone and 20 μg or 30 μg ethinyl estradiol for polycystic ovary syndrome.
abstract: OBJECTIVE
  To compare the effects of 30 μg and 20 μg ethinyl estradiol (EE) among women with polycystic ovary syndrome (PCOS).
  
  
  METHODS
  In a randomized study, patients with PCOS, a history of six or fewer menstrual cycles in the previous 12 months, and abnormal body hair growth were enrolled at a center in Kolkata, India, between May 1, 2012, and January 31, 2014. Participants were randomly assigned (1:1) using a computer-generated randomization table to receive an oral contraceptive pill containing 3mg drospirenone and either 30 μg EE or 20 μg EE. Patients were followed up after 6 and 12 months. The primary outcome was the absolute change in the free androgen index. Participants were masked to group assignment but investigators were not. Analyses were by intention to treat.
  
  
  RESULTS
  Overall, 112 patients were enrolled. At 6 months, the free androgen index had decreased by 4.96±6.01 among patients receiving 30 μg (n=55) and by 4.81±6.03 among those receiving 20 μg (n=57; P=0.89). At 12 months, the decrease from baseline was 5.23±5.79 with 30 μg and 4.99±5.86 with 20 μg (P=0.82).
  
  
  CONCLUSIONS
  Among patients with PCOS, an oral contraceptive pill containing 20 μg EE has similar effects on androgen levels to those of a pill containing 30 μg.
  
  
  BACKGROUND
  CTRI/2012/04/002571.
authors.affiliation: Department of Obstetrics and Gynecology, S. C. Das Memorial Medical and Research Center, Jodhpur Park, Kolkata, India; Department of Obstetrics and Gynecology, KPC Medical College and Hospital, Jadavpur, Kolkata, India. Electronic address: drsudhindra54@gmail.com.
authors.forename: Sudhindra M
authors.initials: SM
authors.lastname: Bhattacharya
authors.affiliation: Charleston Area Medical Center Health Education and Research Institute, Charleston Area Medical Center, Charleston, WV, USA.
authors.forename: Ayan
authors.initials: A
authors.lastname: Jha
authors.affiliation: Department of Obstetrics and Gynecology, KPC Medical College and Hospital, Jadavpur, Kolkata, India.
authors.forename: Lipika
authors.initials: L
authors.lastname: DasMukhopadhyay
mesh_terms: D000328:Adult; D000726:Androgen Antagonists; D000728:Androgens / Q000097:blood; D000736:Androstenes / Q000008:administration & dosage*; D003277:Contraceptives, Oral, Combined; D004967:Estrogens / Q000008:administration & dosage*; D004997:Ethinyl Estradiol / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007194:India; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage*; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000726:Androgen Antagonists; D000728:Androgens; D000736:Androstenes; D003277:Contraceptives, Oral, Combined; D004967:Estrogens; D000451:Mineralocorticoid Receptor Antagonists; D004997:Ethinyl Estradiol; C035144:drospirenone
keywords: Combined oral contraceptive pill; Drospirenone; Ethinyl estradiol dose; Hyperandrogenism; Insulin resistance; Polycystic ovary syndrome