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.
Study Design
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/m2] and after treatment [26 (3.7) kg/m2].
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.
Keywords
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References
- Contraceptive hormone use and cardiovascular disease.J Am Coll Cardiol. 2009; 53: 221-231
- Cardiovascular disease and combined oral contraceptives: reviewing the evidence and balancing the risks.Hum Reprod Update. 1999; 5: 721-735
- The influence of female sex steroids on glucose metabolism and insulin action.J Intern Med Suppl. 1996; 738: 1-60
- Safety evaluation of modern oral contraceptives. Effects on lipoprotein and carbohydrate metabolism.Contraception. 1998; 57: 189-201
- Insulin sensitivity and lipid metabolism with oral contraceptives containing chlormadinone acetate or desogestrel: a randomized trial.Contraception. 2009; 79: 111-116
- Effect of an oral contraceptive containing 30 microg ethinylestradiol plus 3 mg drospirenone on body composition of young women affected by premenstrual syndrome with symptoms of water retention.Contraception. 2007; 76: 190-194
- Effects of two different oral contraceptives on total body water: a randomized study.Contraception. 2006; 73: 344-347
- Steroidal contraceptives: effect on carbohydrate metabolism in women without diabetes mellitus.Cochrane Database Syst Rev. 2009; 4: CD006133
Sitruk-Ware R, Nath A. Metabolic effects of contraceptive steroids. Rev Endocr Metab Disord; Published, online 03–05–2011.
- Hormonal contraception: present and future.Drugs Today. 2008; 44: 905-923
- Evaluation of a new estradiol oral contraceptive: estradiol valerate and dienogest.Expert Opin Pharmacother. 2010; 11: 1147-1157
- The effects of oral and transdermal hormone replacement therapy on C-reactive protein levels and other inflammatory markers in women with high risk of thrombosis.Maturitas. 2005; 52: 111-118
Hoy SM, Scott LJ, Estradiol valerate/dienogest in oral contraception. Drugs 2009; 20;69:1635–46. Review.
Parke S, Nahum G, Mellinger U, Junge W. Metabolic effects of a new four-phasic oral contraceptive containing estradiol valerate and dienogest. Obstet Gynecol 2008;111 (4 Suppl)12:3.
- A 19-norprogestin without a 17a-ethinyl group I: dienogest from a pharmacokinetic point of view.Drugs Today. 1995; 31: 499-516
- Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome.Fertil Steril. 2004; 81: 19-25
- Insulin-lowering agents in the management of polycystic ovary syndrome.Endocr Rev. 2003; 24: 633-667
- A modern medical quandary: polycystic ovary syndrome, insulin resistance and oral contraceptive pills.J Clin Endocrinol Metab. 2003; 88: 1927-1932
- Polycystic ovary syndrome, oral contraceptives and metabolic issues: new perspectives and a unifying hypothesis.Hum Reprod. 2007; 22: 317-322
- Use and abuse of HOMA modeling.Diabetes Care. 2004; 27: 1487-1495
- Effect of estrogen treatment for one year on carbohydrate and lipid metabolism in women with normal and abnormal glucose tolerance test results. Glucose, insulin, growth hormone, triglycerides, and Premarin.Am J Obstet Gynecol. 1978; 131: 87-90
- The effects of two years of mestranol treatment on carbohydrate metabolism.Metabolism. 1982; 31: 1006-1008
- Insulin resistance, secretion, and metabolism in users of oral contraceptives.J Clin Endocrinol Metab. 1992; 74: 64-70
- Insulin sensitivity is decreased in normal women by doses of ethinyl estradiol used in oral contraceptives.Am J Obstet Gynecol. 1993; 169: 1540-1544
- The pharmacological profile of dienogest.Eur J Contracept Reprod Health Care. 1999; 4: 2-13
Article info
Publication history
Published online: June 17, 2013
Accepted:
September 6,
2012
Received in revised form:
August 28,
2012
Received:
February 7,
2012
Identification
Copyright
© 2013 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
