The main objective of the study is to compare the metabolic effects of natural estradiol and synthetic ethinylestradiol used in combined oral contraception in healthy women. A progestin-only preparation will be used in comparison. The main goal is to study the effects on glucose metabolism, coagulation and a markers of chronic inflammation (such as hs-CRP). Our hypothesis is that the natural estradiol preparation will influence blood glucose levels, markers of coagulation and chronic inflammation less than the ethinylestradiol preparation. The progestin-only preparation will not effect these parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
59
One tablet orally for 9 weeks, continuous use
One tablet orally for 9 weeks, continuous use
One tablet orally for 9 weeks, continuous use
Helsinki University Central Hospital, Kätilöopisto Maternity Hospital
Helsinki, Finland
Oulu University Hospital, Department of Gynecology and Obstetrics
Oulu, Finland
Matsuda Index- Whole Body Insulin Sensitivity Index
Matsuda index is calculated from the standard 2h Oral Glucose Tolerance Test and corresponding insulin values. Matsuda index = 10,000/square root of \[fasting glucose x fasting insulin\] x \[mean glucose x mean insulin during OGTT\]) The Matsuda index is correlated (r = 0.73) with the rate of whole-body glucose disposal during the euglycemic insulin clamp. Matsuda index \<2.5 is considered insulin resistant, higher values indicate less insulin resistance. A decrease in matsuda index over the study period would indicate decreased insulin sensitivity.
Time frame: We calculated the change in Matsuda index from baseline to 9 weeks.
Fasting Insulin
Mean change in fasting serum insulin from baseline to nine weeks
Time frame: baseline and 9 weeks
High-sensitivity C Reactive Protein
Change in plasma concentrations of acute phase protein 'C reactive protein' (CRP), a marker of chronic inflammation.
Time frame: baseline and 9 weeks
Total Cholesterol
Change in concentrations of total cholesterol from baseline to nine weeks
Time frame: baseline and 9 weeks
Low-Density Lipoprotein (LDL)
Change in concentration of Low-Density Lipoprotein LDL from baseline to nine weeks
Time frame: baseline and 9 weeks
High-Density Lipoprotein (HDL)
Change in concentration of High-Density Lipoprotein HDL from baseline to nine weeks
Time frame: baseline and 9 weeks
Triglyceride
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Change in triglyceride concentrations from baseline to nine weeks
Time frame: baseline and 9 weeks
D-dimer
Markers of coagulation activation
Time frame: baseline and 9 weeks
F1+2
Change in plasma concentrations of F1+2 a marker of coagulation activation
Time frame: baseline and 9 weeks
Thrombin Generation, ETP Endogenous Thrombin Potential
Change from baseline in thrombin generation, measured by thrombin generation assay-Calibrated automated thrombogram
Time frame: baseline and 9 weeks