Abstract
Purpose of investigation:
To compare the effects of desogestrel (DSG) 150 mcg/ethinyl estradiol (EE) 20 mcg for 21 days followed by either seven days of EE ten mcg (21/7-active) or no treatment (DSG/EE+no Tx) on hemostatic markers.
Materials and methods:
This was a randomized, multicenter, open-label study that enrolled healthy premenopausal women. Non-inferiority of 21/7-active to DSG/EE+no Tx was determined if the upper limit of the two-sided 95% CI of the mean treatment difference in prothrombin fragment 1+2 (F1+2) over 24 weeks between groups was < 130 pmol/L.
Results:
246 subjects (n = 125, 21/7-active; n = 121, DSG/EE+no Tx) comprised the primary analysis. Mean F1+2 levels increased in both 21/7-active and DSG/EE+no Tx regimens (least square [LS] mean changes +45 pmol/L and +56.8 pmol/L, respectively). LS mean treatment difference was -11.8 pmol/L (95% CI: -54.8, 31.2).
Conclusion:
The effect of adding EE ten mcg to the seven-day hormone-free interval of DSG/EE on F1+2 levels was non-inferior to traditional DSG/EE.
Trial registration:
ClinicalTrials.gov NCT01388491.
Publication types
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Antithrombins / blood
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Blood Coagulation / drug effects*
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Contraceptives, Oral, Combined / administration & dosage
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Contraceptives, Oral, Combined / pharmacology*
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Contraceptives, Oral, Sequential / administration & dosage
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Contraceptives, Oral, Sequential / pharmacology*
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Desogestrel / administration & dosage
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Desogestrel / pharmacology*
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Ethinyl Estradiol / administration & dosage
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Ethinyl Estradiol / pharmacology*
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Female
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Fibrin Fibrinogen Degradation Products / drug effects*
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Fibrin Fibrinogen Degradation Products / metabolism
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Humans
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Partial Thromboplastin Time
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Peptide Fragments / blood
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Peptide Fragments / drug effects*
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Protein C / drug effects*
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Protein C / metabolism
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Protein S / drug effects*
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Protein S / metabolism
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Prothrombin / drug effects*
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Young Adult
Substances
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Antithrombins
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Contraceptives, Oral, Combined
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Contraceptives, Oral, Sequential
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Fibrin Fibrinogen Degradation Products
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Peptide Fragments
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Protein C
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Protein S
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fibrin fragment D
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prothrombin fragment 1.2
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Ethinyl Estradiol
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Desogestrel
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Prothrombin
Associated data
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ClinicalTrials.gov/NCT01388491