Hemostatic effects of two desogestrel-containing combined oral contraceptive regimens: a multinational, multicenter, randomized, open-label study.
OBJECTIVE
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.


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).


CONCLUSIONS
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.
K
K
Peters
N
N
Gordon
N
N
Ricciotti
J
J
Hsieh
B
B
Howard
H
H
Weiss
D000328:Adult; D000991:Antithrombins / Q000097:blood; D001777:Blood Coagulation / Q000187:drug effects*; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000494:pharmacology*; D003279:Contraceptives, Oral, Sequential / Q000008:administration & dosage / Q000494:pharmacology*; D017135:Desogestrel / Q000008:administration & dosage / Q000494:pharmacology*; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000494:pharmacology*; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000187:drug effects* / Q000378:metabolism; D006801:Humans; D010314:Partial Thromboplastin Time; D010446:Peptide Fragments / Q000097:blood / Q000187:drug effects*; D011486:Protein C / Q000187:drug effects* / Q000378:metabolism; D017293:Protein S / Q000187:drug effects* / Q000378:metabolism; D011516:Prothrombin / Q000187:drug effects*; D055815:Young Adult
D000991:Antithrombins; D003277:Contraceptives, Oral, Combined; D003279:Contraceptives, Oral, Sequential; D005338:Fibrin Fibrinogen Degradation Products; D010446:Peptide Fragments; D011486:Protein C; D017293:Protein S; C036309:fibrin fragment D; C045879:prothrombin fragment 1.2; D004997:Ethinyl Estradiol; D017135:Desogestrel; D011516:Prothrombin