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Register:	ClinicalTrials.gov
Last refreshed on:	1 March 2021
Main ID:	NCT02352090
Date of registration:	20/01/2015
Prospective Registration:	Yes
Primary sponsor:	Helsinki University Central Hospital
Public title:	Synthetic vs Natural Estrogen in Combined Oral Contraception SYLVI
Scientific title:	Synthetic vs Natural Estrogen in Combined Oral Contraception- Effect on Insulin Sensitivity, Coagulation, Inflammation and Endometrium - a Comparison With a Progestin-only Preparation.
Date of first enrolment:	April 1, 2015
Target sample size:	59
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02352090
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
Finland

Contacts

Name:	Terhi Piltonen, PhD, MD
Address:
Telephone:
Email:
Affiliation:	Oulu University Hospital, Department of Gynecology and Obstetrics

Name:	Juha Tapanainen, Prof., PhD, MD.
Address:
Telephone:
Email:
Affiliation:	Helsinki University Central Hospital, Department of Gynecology and Obstetrics. Helsinki Univeristy, Medical Faculty

Name:	Annina Haverinen, MD, PhD student
Address:
Telephone:
Email:
Affiliation:	Helsinki University Central Hospital, Department of Gynecology and Obstetrics. Helsinki University, Faculty of Medicine

Name:	Oskari Heikinheimo, Prof., PhD., MD.
Address:
Telephone:
Email:
Affiliation:	Helsinki University Central Hospital, Department of Gynecology and Obstetrics. Helsinki Univeristy, Medical Faculty

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 35 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Contraception

Intervention(s)

Drug: Ethinyl estradiol / dienogest

Drug: Dienogest

Drug: Estradiol valerate / dienogest

Primary Outcome(s)

Change from baseline in Glycosylated Hemoglobin [Time Frame: baseline and 9 weeks]

Change from baseline in serum insulin at 9 weeks [Time Frame: baseline and 9 weeks]

Change from baseline in plasma glucose concentrations during 'Two hour Oral glucose tolerance test' at 9 weeks [Time Frame: baseline and 9 weeks]

Secondary Outcome(s)

Change from baseline in Activated Protein C resistance at 9 weeks [Time Frame: baseline and 9 weeks]

Change from baseline in plasma Low-Density Lipoprotein (LDL) at 9 weeks [Time Frame: baseline and 9 weeks]

Change from baseline in plasma triglyceride concentrations at 9 weeks [Time Frame: baseline and 9 weeks]

Change from baseline Prothrombin fragment I and II at 9 weeks [Time Frame: baseline and 9 weeks]

Change from baseline in marker of chronic inflammation at 9 weeks [Time Frame: baseline and 9 weeks]

Change from baseline in mononuclear cell inflammatory response at 9 weeks [Time Frame: baseline and 9 weeks]

Change from baseline in plasma Low-Density Lipoprotein (LDL) at 5 weeks [Time Frame: baseline and 5 weeks]

Change from baseline in serum D-dimer concentrations at 9 weeks [Time Frame: baseline and 9 weeks]

Change from baseline in total plasma cholesterol at 9 weeks [Time Frame: baseline and 9 weeks]

Change from baseline in plasma High-Density Lipoprotein (HDL) at 5 weeks [Time Frame: baseline and 5 weeks]

Change from baseline in total plasma cholesterol at 5 weeks [Time Frame: baseline and 5 weeks]

Change from baseline in plasma triglyceride concentrations at 5 weeks [Time Frame: baseline and 5 weeks]

Change from baseline in marker of chronic inflammation at 5 weeks [Time Frame: baseline and 5 weeks]

Change from baseline in plasma High-Density Lipoprotein (HDL) at 9 weeks [Time Frame: baseline and 9 weeks]

Secondary ID(s)

SYLVI030785

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oulu University Hospital

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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