Folate status and homocysteine levels during a 24-week oral administration of a folate-containing oral contraceptive: a randomized, double-blind, active-controlled, parallel-group, US-based multicenter study

Abstract Background This study investigated the effects of adding levomefolate calcium 0.451 mg (the calcium salt of L-5-methyltetrahydrofolate; Metafolin��) to an oral contraceptive containing ethinylestradiol (EE) 20 mcg/drospirenone (drsp) 3 mg on folate levels in healthy women seeking contraception. Study Design In this randomized, double-blind, multicenter US-based study, women (18���40 years) received 24 weeks (six cycles) of EE/drsp/levomefolate calcium or EE/drsp for 24 days followed by 4 days of levomefolate calcium alone or placebo, respectively. The primary efficacy variables were red blood cell (RBC) and plasma folate levels at 24 weeks. Results At week 24, increases from baseline in mean RBC (990 �� 390 nmol/L to 1406 �� 440 nmol/L) and plasma folate (45.0 �� 17.6 nmol/L to 60.8 �� 19.9 nmol/L) levels were observed in women who received EE/drsp/levomefolate calcium [per protocol set ( n =262); all values are displayed as mean �� standard deviation]. In contrast, marginal fluctuations were observed with EE/drsp (p Conclusion Clinically significant increases in folate status were observed with EE/drsp/levomefolate calcium compared with EE/drsp alone in US women of childbearing age.