- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02352090
Synthetic vs Natural Estrogen in Combined Oral Contraception (SYLVI)
Synthetic vs Natural Estrogen in Combined Oral Contraception- Effect on Insulin Sensitivity, Coagulation, Inflammation and Endometrium - a Comparison With a Progestin-only Preparation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland
- Helsinki University Central Hospital, Kätilöopisto Maternity Hospital
-
Oulu, Finland
- Oulu University Hospital, Department of Gynecology and Obstetrics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Synthetic estrogen + progestin
Ethinyl estradiol / dienogest
|
One tablet orally for 9 weeks, continuous use
Other Names:
|
Experimental: Natural estrogen + progestin
Estradiol valerate / dienogest
|
One tablet orally for 9 weeks, continuous use
Other Names:
|
Active Comparator: Progestin-Only
Dienogest
|
One tablet orally for 9 weeks, continuous use
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
We calculated the change in Matsuda index from baseline to 9 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting Insulin
Time Frame: baseline and 9 weeks
|
Mean change in fasting serum insulin from baseline to nine weeks
|
baseline and 9 weeks
|
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.
|
baseline and 9 weeks
|
Total Cholesterol
Time Frame: baseline and 9 weeks
|
Change in concentrations of total cholesterol from baseline to nine weeks
|
baseline and 9 weeks
|
Low-Density Lipoprotein (LDL)
Time Frame: baseline and 9 weeks
|
Change in concentration of Low-Density Lipoprotein LDL from baseline to nine weeks
|
baseline and 9 weeks
|
High-Density Lipoprotein (HDL)
Time Frame: baseline and 9 weeks
|
Change in concentration of High-Density Lipoprotein HDL from baseline to nine weeks
|
baseline and 9 weeks
|
Triglyceride
Time Frame: baseline and 9 weeks
|
Change in triglyceride concentrations from baseline to nine weeks
|
baseline and 9 weeks
|
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
|
baseline and 9 weeks
|
D-dimer
Time Frame: baseline and 9 weeks
|
Markers of coagulation activation
|
baseline and 9 weeks
|
F1+2
Time Frame: baseline and 9 weeks
|
Change in plasma concentrations of F1+2 a marker of coagulation activation
|
baseline and 9 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline and 9 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Oskari Heikinheimo, Prof., PhD., MD., Helsinki University Central Hospital, Department of Gynecology and Obstetrics. Helsinki Univeristy, Medical Faculty
- Study Chair: Juha Tapanainen, Prof., PhD, MD., Helsinki University Central Hospital, Department of Gynecology and Obstetrics. Helsinki Univeristy, Medical Faculty
- Principal Investigator: Terhi Piltonen, PhD, MD, Oulu University Hospital, Department of Gynecology and Obstetrics
- Principal Investigator: Annina Haverinen, MD, PhD student, Helsinki University Central Hospital, Department of Gynecology and Obstetrics. Helsinki University, Faculty of Medicine
Publications and helpful links
General Publications
- Kangasniemi MH, Arffman RK, Haverinen A, Luiro K, Hustad S, Heikinheimo O, Tapanainen JS, Piltonen TT. Effects of estradiol- and ethinylestradiol-based contraceptives on adrenal steroids: A randomized trial. Contraception. 2022 Dec;116:59-65. doi: 10.1016/j.contraception.2022.08.009. Epub 2022 Sep 7.
- Haverinen AH, Luiro KM, Szanto T, Kangasniemi MH, Hiltunen L, Sainio S, Piltonen TT, Lassila R, Tapanainen JS, Heikinheimo O. Combined oral contraceptives containing estradiol valerate vs ethinylestradiol on coagulation: A randomized clinical trial. Acta Obstet Gynecol Scand. 2022 Oct;101(10):1102-1111. doi: 10.1111/aogs.14428. Epub 2022 Jul 31.
- Kangasniemi MH, Haverinen A, Luiro K, Hiltunen JK, Komsi EK, Arffman RK, Heikinheimo O, Tapanainen JS, Piltonen TT. Estradiol Valerate in COC Has More Favorable Inflammatory Profile Than Synthetic Ethinyl Estradiol: A Randomized Trial. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa186. doi: 10.1210/clinem/dgaa186.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Estrogens
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Hormonal
- Androgens
- Contraceptive Agents, Male
- Anabolic Agents
- Estradiol
- Ethinyl Estradiol
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
- Dienogest
- Nandrolone
Other Study ID Numbers
- SYLVI030785
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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