title: 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.
  
  
  METHODS
  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<.0001 for between-treatment differences at week 24).
  
  
  CONCLUSIONS
  Clinically significant increases in folate status were observed with EE/drsp/levomefolate calcium compared with EE/drsp alone in US women of childbearing age.
authors: SNBL Clinical Pharmacology Center, Baltimore, MD 21163, USA. dokcyber@earthlink.net
authors: Stephan
authors: S
authors: Bart
authors: Joachim
authors: J
authors: Marr
authors: Konstanze
authors: K
authors: Diefenbach
authors: Dietmar
authors: D
authors: Trummer
authors: Carole
authors: C
authors: Sampson-Landers
mesh_terms: D000293:Adolescent; D000328:Adult; D000736:Androstenes / Q000008:administration & dosage / Q000009:adverse effects; D002118:Calcium / Q000008:administration & dosage* / Q000009:adverse effects; D003276:Contraceptives, Oral / Q000009:adverse effects; D004311:Double-Blind Method; D004967:Estrogens / Q000008:administration & dosage / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005492:Folic Acid / Q000097:blood*; D005971:Glutamates / Q000008:administration & dosage* / Q000009:adverse effects; D006710:Homocysteine / Q000097:blood*; D006801:Humans; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage / Q000009:adverse effects; D009436:Neural Tube Defects / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000736:Androstenes; D003276:Contraceptives, Oral; D004967:Estrogens; D005971:Glutamates; D000451:Mineralocorticoid Receptor Antagonists; D006710:Homocysteine; D004997:Ethinyl Estradiol; D005492:Folic Acid; C569381:levomefolate calcium; C035144:drospirenone; D002118:Calcium