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NCT Number: NCT02352090

Synthetic vs Natural Estrogen in Combined Oral Contraception

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.

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Key information

Conditions

Contraception Cardiovascular Diseases Embolism and Thrombosis Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Thrombosis Vascular Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki University Central Hospital, Kätilöopisto Maternity Hospital, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ethinyl estradiol / dienogest

Drug

One tablet orally for 9 weeks, continuous use

Other names: Valette, ATC code G03AA

Estradiol valerate / dienogest

Drug

One tablet orally for 9 weeks, continuous use

Other names: Qlaira, ATC code G03AB08

Dienogest

Drug

One tablet orally for 9 weeks, continuous use

Other names: Visanne, ATC code G03D

Primary outcomes

  1. Matsuda Index- Whole Body Insulin Sensitivity Index

    Time frame: We calculated the change in Matsuda index from baseline to 9 weeks.

    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.

Secondary outcomes

  1. Fasting Insulin

    Time frame: baseline and 9 weeks

    Mean change in fasting serum insulin from baseline to nine weeks

  2. High-sensitivity C Reactive Protein

    Time frame: baseline and 9 weeks

    Change in plasma concentrations of acute phase protein 'C reactive protein' (CRP), a marker of chronic inflammation.

  3. Total Cholesterol

    Time frame: baseline and 9 weeks

    Change in concentrations of total cholesterol from baseline to nine weeks

  4. Low-Density Lipoprotein (LDL)

    Time frame: baseline and 9 weeks

    Change in concentration of Low-Density Lipoprotein LDL from baseline to nine weeks

  5. High-Density Lipoprotein (HDL)

    Time frame: baseline and 9 weeks

    Change in concentration of High-Density Lipoprotein HDL from baseline to nine weeks

  6. Triglyceride

    Time frame: baseline and 9 weeks

    Change in triglyceride concentrations from baseline to nine weeks

  7. D-dimer

    Time frame: baseline and 9 weeks

    Markers of coagulation activation

  8. F1+2

    Time frame: baseline and 9 weeks

    Change in plasma concentrations of F1+2 a marker of coagulation activation

  9. Thrombin Generation, ETP Endogenous Thrombin Potential

    Time frame: baseline and 9 weeks

    Change from baseline in thrombin generation, measured by thrombin generation assay-Calibrated automated thrombogram

Other outcomes

  1. Anti Mullerian Hormone (AMH)

    Time frame: baseline and 9 weeks

    Change in Serum concentrations of anti-mullerian hormone reflecting ovarian reserve from baseline to nine weeks

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Oulu University Hospital

Registry information

Official study title

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

Acronym: SYLVI

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 2, 2015
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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