Hemostatic effects of two desogestrel-containing combined oral contraceptive regimens: a multinational, multicenter, randomized, open-label study.
Clin Exp Obstet Gynecol
; 43(3): 334-40, 2016.
Article
en En
| MEDLINE
| ID: mdl-27328486
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.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Fragmentos de Péptidos
/
Coagulación Sanguínea
/
Productos de Degradación de Fibrina-Fibrinógeno
/
Protrombina
/
Proteína C
/
Proteína S
/
Desogestrel
/
Anticonceptivos Orales Combinados
/
Anticonceptivos Secuenciales Orales
/
Etinilestradiol
Tipo de estudio:
Clinical_trials
Límite:
Adult
/
Female
/
Humans
Idioma:
En
Revista:
Clin Exp Obstet Gynecol
Año:
2016
Tipo del documento:
Article