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Synthetic vs Natural Estrogen in Combined Oral Contraception (SYLVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352090
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
Oulu University Hospital
Information provided by (Responsible Party):
Annina Haverinen, Helsinki University Central Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Contraception Drug: Ethinyl estradiol / dienogest Drug: Estradiol valerate / dienogest Drug: Dienogest Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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.
Study Start Date : February 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Synthetic estrogen + progestin
Ethinyl estradiol / dienogest
Drug: Ethinyl estradiol / dienogest
One tablet orally for 9 weeks, continuous use
Other Name: Valette, ATC code G03AA

Experimental: Natural estrogen + progestin
Estradiol valerate / dienogest
Drug: Estradiol valerate / dienogest
One tablet orally for 9 weeks, continuous use
Other Name: Qlaira, ATC code G03AB08

Active Comparator: Progestin-Only
Dienogest
Drug: Dienogest
One tablet orally for 9 weeks, continuous use
Other Name: Visanne, ATC code G03D




Primary Outcome Measures :
  1. Change from baseline in plasma glucose concentrations during 'Two hour Oral glucose tolerance test' at 9 weeks [ Time Frame: baseline and 9 weeks ]
    Plasma glucose concentrations during 'two hour oral glucose tolerance test' (2hOGGT) conducted at baseline and at 9 weeks

  2. Change from baseline in Glycosylated Hemoglobin [ Time Frame: baseline and 9 weeks ]
    Glycosylated hemoglobin (HbA1c%)

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


Secondary Outcome Measures :
  1. Change from baseline in marker of chronic inflammation at 5 weeks [ Time Frame: baseline and 5 weeks ]
    Plasma concentrations of acute phase protein 'C reactive protein' (CRP)

  2. Change from baseline in marker of chronic inflammation at 9 weeks [ Time Frame: baseline and 9 weeks ]
    Plasma concentrations of acute phase protein 'C reactive protein' (CRP)

  3. Change from baseline in mononuclear cell inflammatory response at 9 weeks [ Time Frame: baseline and 9 weeks ]
    Mononuclear cell Interleukin 6 secretion

  4. Change from baseline in mononuclear cell inflammatory response at 9 weeks [ Time Frame: baseline and 9 weeks ]
    Mononuclear cell Nuclear factor kappa-light-chain-enhancer of activated B cells -activation (NFkB-activation)

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

  6. Change from baseline in total plasma cholesterol at 9 weeks [ Time Frame: baseline and 9 weeks ]
    Plasma concentrations of total cholesterol

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

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

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

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

  11. Change from baseline in plasma triglyceride concentrations at 5 weeks [ Time Frame: baseline and 5 weeks ]
    Plasma concentration triglycerides

  12. Change from baseline in plasma triglyceride concentrations at 9 weeks [ Time Frame: baseline and 9 weeks ]
    Plasma concentration triglycerides

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

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

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


Other Outcome Measures:
  1. Endometrial proliferation at 9 weeks [ Time Frame: 9 weeks ]
    Endometrial biopsy with immunohistological evaluation of markers of proliferation

  2. Change from baseline in Anti Mullerian Hormone concentrations at 9 weeks [ Time Frame: baseline and 9 weeks ]
    Change in Serum concentrations of anti-mullerian hormone reflecting ovarian reserve

  3. Number of days with vaginal bleeding [ Time Frame: 9 weeks ]
    Self-reported days of bleeding in bleeding diary.

  4. Patterns of vaginal bleeding [ Time Frame: 9 weeks ]
    Self- reported clusters of bleeding days in bleeding diary.

  5. Change from baseline in Quality of Life scores at 9 weeks [ Time Frame: baseline and 9 weeks ]
    Quality of life questionnaire (EQ-5D questionnaire)

  6. Change from baseline in Anxiety scores at 9 weeks [ Time Frame: baseline and 9 weeks ]
    State-Trait Anxiety Inventory (STAI) questionnaire

  7. Change from baseline in sexuality scores at 9 weeks [ Time Frame: baseline and 9 weeks ]
    Mccoy female sexuality questionnaire (MFSQ) questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352090


Locations
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Finland
Helsinki University Central Hospital, Kätilöopisto Maternity Hospital
Helsinki, Finland
Oulu University Hospital, Department of Gynecology and Obstetrics
Oulu, Finland
Sponsors and Collaborators
Helsinki University Central Hospital
Oulu University Hospital
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Annina Haverinen, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02352090    
Other Study ID Numbers: SYLVI030785
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Keywords provided by Annina Haverinen, Helsinki University Central Hospital:
Contraception, oral
Ethinyl Estradiol
Estradiol Valerate
Dienogest
Insulin resistance
Chronic inflammation
Coagulation
Additional relevant MeSH terms:
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Dienogest
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Nandrolone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgens
Anabolic Agents