Phase 4
Completed N=59
Synthetic vs Natural Estrogen in Combined Oral Contraception
Source: ClinicalTrials.gov NCT02352090 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Matsuda Index- Whole Body Insulin Sensitivity Index — -1.02; -0.10; -1.45 units on a scale — p=0.27
◆ Published Evidence
Established
20citations · ~3 / year
Estradiol Valerate in COC Has More Favorable Inflammatory Profile Than Synthetic Ethinyl Estradiol: A Randomized Trial.
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.
Linked Publications (4)
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Estradiol Valerate in COC Has More Favorable Inflammatory Profile Than Synthetic Ethinyl Estradiol: A Randomized Trial.
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Combined oral contraceptives containing estradiol valerate vs ethinylestradiol on coagulation: A randomized clinical trial.
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Effects of estradiol- and ethinylestradiol-based contraceptives on adrenal steroids: A randomized trial.
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Ethinylestradiol in combined hormonal contraceptive has a broader effect on serum proteome compared with estradiol valerate: a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Matsuda Index- Whole Body Insulin Sensitivity Index |
-1.02; -0.10; -1.45 | 0.27 |
| SECONDARY Fasting Insulin |
1.4; 1.02; 1.99 | — |
| SECONDARY High-sensitivity C Reactive Protein |
1.10; -0.06; 0.13 | — |
| SECONDARY Total Cholesterol |
0.10; -0.16; 0.11 | — |
| SECONDARY Low-Density Lipoprotein (LDL) |
-0.16; -0.14; 0.01 | — |
| SECONDARY High-Density Lipoprotein (HDL) |
0.20; -0.02; -0.02 | — |
| SECONDARY Triglyceride |
0.45; 0.18; 0.06 | — |
| SECONDARY D-dimer |
12.6; 2.4; -1.6 | — |
| SECONDARY F1+2 |
24.1; -5.5; -8.5 | — |
| SECONDARY Thrombin Generation, ETP Endogenous Thrombin Potential |
63.9; 26.4; 7.1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02352090) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.