title: Effect of a new oral contraceptive with estradiol valerate/dienogest on carbohydrate metabolism.
abstract: BACKGROUND
  Insulin resistance may be induced by both the estrogen and progestin component in hormonal contraception. When estrogen dose is reduced from 50 to 20 mcg, the extent of hyperinsulinemia decreases. Recently, the oral combination contraceptive (COC) containing estradiol valerate (E2V) in combination with dienogest (DNG) was developed in a new estrogen step-down, progesterone step-up dosing strategy (Qlaira, Bayer Healthcare Pharmaceuticals). This study was conducted to evaluate of the effect of a 3-month treatment with E2V/DNG on carbohydrate metabolism in women with polycystic ovarian syndrome (PCOS) and insulin resistance.
  
  
  METHODS
  Study consisted of subjects attending the gynecological clinic of Siena or Pisa, with PCOS and insulin resistance, and without contraindications for the use of COCs. PCOS females (n=20) aged 18 to 33 years were treated with a contraceptive formulation containing E2V/DNG for 3 months. Before treatment and during the third month of therapy, body mass index (BMI) measurement and an oral glucose tolerance test (OGTT) were performed.
  
  
  RESULTS
  Median values of insulin after treatment were lower than median values before treatment. In particular, the median value of insulin at T0 was reduced by 54.6% (p<.001), and the mean difference between time 0 and 30 min was significantly reduced [42.96 (9.99) mU/mL vs 38.00 (15.10) mU/mL; p<.05]. Homeostasis model assessment of insulin resistance levels were significantly decreased following treatment. OGTT after treatment revealed median fasting glucose levels to be stable (p=.895) at T0. At T30, T60, T120 and T180 min, glucose median values were moderately reduced in comparison to median values before treatment. No significant difference was observed between median BMI values before [26 (4.8) kg/m(2)] and after treatment [26 (3.7) kg/m(2)].
  
  
  CONCLUSIONS
  Median insulin levels at T0 and the mean difference between time 0 and 30 of insulin following OGTT were significantly reduced than values before treatment with E2V/DNG for 3 months. Median BMI and glucose levels were not significantly modified. Natural estradiol and nonandrogenic progestogen in the Qlaira formulation could be recommended as an oral contraceptive in women with PCOS who are insulin resistant or who are overweight.
authors.affiliation: Department of Molecular and Development Medicine, University of Siena, Italy. vincenzo.deleo@unisi.it
authors.forename: Vincenzo
authors.initials: V
authors.lastname: De Leo
authors.forename: Franca
authors.initials: F
authors.lastname: Fruzzetti
authors.forename: Maria Concetta
authors.initials: MC
authors.lastname: Musacchio
authors.forename: Valeria
authors.initials: V
authors.lastname: Scolaro
authors.forename: Alessandra
authors.initials: A
authors.lastname: Di Sabatino
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Morgante
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D015992:Body Mass Index; D050260:Carbohydrate Metabolism / Q000187:drug effects*; D003277:Contraceptives, Oral, Combined / Q000009:adverse effects*; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005215:Fasting; D005260:Female; D005951:Glucose Tolerance Test; D006801:Humans; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D007558:Italy; D009277:Nandrolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D050177:Overweight / Q000150:complications; D011085:Polycystic Ovary Syndrome / Q000150:complications*; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D003277:Contraceptives, Oral, Combined; D004338:Drug Combinations; D007328:Insulin; C454300:estradiol valerate-dienogest; C023635:dienogest; D004958:Estradiol; D009277:Nandrolone
keywords: Carbohydrate metabolism; Contraception; Dienogest; Estradiol valerate; Insulin sensitivity