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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02352090
Other study ID # SYLVI030785
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 1, 2015
Est. completion date December 30, 2018

Study information

Verified date May 2023
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - BMI 19-24.9, regular menstrual cycles (21-35 days), a minimum of 2 months without any hormonal contraceptives, no contraindications for use of hormonal contraception Exclusion Criteria: - Polycystic ovaries, hypertension, smoking, alcohol abuse, pregnancy, lactation, abnormal result in pre-screening 2h oral glucose tolerance test, regular medications

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ethinyl estradiol / dienogest
One tablet orally for 9 weeks, continuous use
Estradiol valerate / dienogest
One tablet orally for 9 weeks, continuous use
Dienogest
One tablet orally for 9 weeks, continuous use

Locations

Country Name City State
Finland Helsinki University Central Hospital, Kätilöopisto Maternity Hospital Helsinki
Finland Oulu University Hospital, Department of Gynecology and Obstetrics Oulu

Sponsors (2)

Lead Sponsor Collaborator
Helsinki University Central Hospital Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Other Anti Mullerian Hormone (AMH) Change in Serum concentrations of anti-mullerian hormone reflecting ovarian reserve from baseline to nine weeks baseline and 9 weeks
Primary 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.
We calculated the change in Matsuda index from baseline to 9 weeks.
Secondary Fasting Insulin Mean change in fasting serum insulin from baseline to nine weeks baseline and 9 weeks
Secondary High-sensitivity C Reactive Protein Change in plasma concentrations of acute phase protein 'C reactive protein' (CRP), a marker of chronic inflammation. baseline and 9 weeks
Secondary Total Cholesterol Change in concentrations of total cholesterol from baseline to nine weeks baseline and 9 weeks
Secondary Low-Density Lipoprotein (LDL) Change in concentration of Low-Density Lipoprotein LDL from baseline to nine weeks baseline and 9 weeks
Secondary High-Density Lipoprotein (HDL) Change in concentration of High-Density Lipoprotein HDL from baseline to nine weeks baseline and 9 weeks
Secondary Triglyceride Change in triglyceride concentrations from baseline to nine weeks baseline and 9 weeks
Secondary D-dimer Markers of coagulation activation baseline and 9 weeks
Secondary F1+2 Change in plasma concentrations of F1+2 a marker of coagulation activation baseline and 9 weeks
Secondary Thrombin Generation, ETP Endogenous Thrombin Potential Change from baseline in thrombin generation, measured by thrombin generation assay-Calibrated automated thrombogram baseline and 9 weeks
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