Synthetic vs Natural Estrogen in Combined Oral Contraception

Contraception Clinical Trial

— SYLVI  

Official title:

Synthetic vs Natural Estrogen in Combined Oral Contraception- Effect on Insulin Sensitivity, Coagulation, Inflammation and Endometrium - a Comparison With a Progestin-only Preparation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02352090
• Other study ID #: SYLVI030785
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Contraception

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