Syntethic vs. natural estrogen in combined oral contraception- effect on insulinsensitivity, inflammation, coagulation and endometrium. A comparison with a progestin-only preparation

Syntethic vs. natural estrogen in combined oral contraception- effect on insulinsensitivity, inflammation, coagulation and endometrium. A comparison with a progestin-only preparation. - SYLVI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001243-20-FI

Enrollment

Registered

2014-05-20

Start date

2014-06-11

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy women, contraception MedDRA version: 17.0 Level: LLT Classification code 10073728 Term: Hormonal contraception System Organ Class: 100000004865

Interventions

Trade Name: Qlaira Pharmaceutical Form: Tablet Trade Name: Valette Pharmaceutical Form: Tablet Trade Name: Visanne Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: woman aged 18-35, normal weight BMI 19-24.9 kg/m2, good general health: no diagnosed disease or regular medications, regular mentrual cycle (21-35 days), prior to entering the study min. 2 months wihout hormonal contraception, no contraindications for the use of hormonal oral combined contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: abnormal results in 2h oral glucose tolerance test, abnormal findings in gyneacological exam (inc. sonography), blood pressure >140/90 mmHg, regular (daily) smoking, alcohol or drug abuse

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 and a markers of chronic inflammation (such as hs-CRP). Our hypothesis is that the natural estradiol preparation will influence blood glucose levels and markers of chronic inflammation less than the ethinylestradiol preparation. The progestin-only preparation will not effect these parameters. ;Secondary Objective: We will study the effects of these preparations on blood pressure, hemostatic markers ja endometrium. We will also conduct a survey prior to entering the study and after 6 weeks of study which evaluates perceived well-being, sexuality and mental health. ;Primary end point(s): Insulin sensitivity as measured by Matsuda index be significantly less affected by estradiol in comparison to ethinylestradiol. The same is true of markers of chronic inflammation. The progestin-only will not effect these parameters.;Timepoint(s) of evaluation of this end point: Evaluation of hs-crp will be done at baseline (0), 4 and 9 weeks. Oral glucose tolerance test will be conducted at baseline and after 9 weeks of continous use of these preparations.	—

Measure

Time frame

Main Objective: 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 and a markers of chronic inflammation (such as hs-CRP). Our hypothesis is that the natural estradiol preparation will influence blood glucose levels and markers of chronic inflammation less than the ethinylestradiol preparation. The progestin-only preparation will not effect these parameters. ;Secondary Objective: We will study the effects of these preparations on blood pressure, hemostatic markers ja endometrium. We will also conduct a survey prior to entering the study and after 6 weeks of study which evaluates perceived well-being, sexuality and mental health. ;Primary end point(s): Insulin sensitivity as measured by Matsuda index be significantly less affected by estradiol in comparison to ethinylestradiol. The same is true of markers of chronic inflammation. The progestin-only will not effect these parameters.;Timepoint(s) of evaluation of this end point: Evaluation of hs-crp will be done at baseline (0), 4 and 9 weeks. Oral glucose tolerance test will be conducted at baseline and after 9 weeks of continous use of these preparations.

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Secondary

Measure	Time frame
Secondary end point(s): Blood-pressure and hemostatic markers will be significiantyl less affected by affected by estradiol in comparison to ethinylestradiol. ;Timepoint(s) of evaluation of this end point: Blood-pressure will be registered at baseline, 4 -weeks and 9 weeks of continuous use of the preparations. Hemostatic markers will be evaluated at baseline and at 9 weeks. Endometrial histology will be obtained after 9 weeks of continuous use of the preparations.	—

Measure

Time frame

Secondary end point(s): Blood-pressure and hemostatic markers will be significiantyl less affected by affected by estradiol in comparison to ethinylestradiol. ;Timepoint(s) of evaluation of this end point: Blood-pressure will be registered at baseline, 4 -weeks and 9 weeks of continuous use of the preparations. Hemostatic markers will be evaluated at baseline and at 9 weeks. Endometrial histology will be obtained after 9 weeks of continuous use of the preparations.

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Countries

Finland

Contacts

Public ContactKätilöopisto Hospital

Helsinki University Central Hospital

oskari.heikinheimo@helsinki.fi+358404271533

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026