PMID- 22067790
OWN - NLM
STAT- MEDLINE
DCOM- 20120406
LR  - 20131121
IS  - 1879-0518 (Electronic)
IS  - 0010-7824 (Linking)
VI  - 85
IP  - 1
DP  - 2012 Jan
TI  - 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.
PG  - 42-50
LID - 10.1016/j.contraception.2011.05.013 [doi]
AB  - BACKGROUND: This study investigated the effects of adding levomefolate calcium 
      0.451 mg (the calcium salt of L-5-methyltetrahydrofolate; Metafolin(R)) 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<.0001 for between-treatment differences at week 24). 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.
CI  - Copyright (c) 2012 Elsevier Inc. All rights reserved.
FAU - Bart, Stephan Sr
AU  - Bart S Sr
AD  - SNBL Clinical Pharmacology Center, Baltimore, MD 21163, USA. 
      dokcyber@earthlink.net
FAU - Marr, Joachim
AU  - Marr J
FAU - Diefenbach, Konstanze
AU  - Diefenbach K
FAU - Trummer, Dietmar
AU  - Trummer D
FAU - Sampson-Landers, Carole
AU  - Sampson-Landers C
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110713
PL  - United States
TA  - Contraception
JT  - Contraception
JID - 0234361
RN  - 0 (Androstenes)
RN  - 0 (Contraceptives, Oral)
RN  - 0 (Estrogens)
RN  - 0 (Glutamates)
RN  - 0 (Mineralocorticoid Receptor Antagonists)
RN  - 0LVT1QZ0BA (Homocysteine)
RN  - 423D2T571U (Ethinyl Estradiol)
RN  - 935E97BOY8 (Folic Acid)
RN  - A9R10K3F2F (levomefolate calcium)
RN  - N295J34A25 (drospirenone)
RN  - SY7Q814VUP (Calcium)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Androstenes/administration & dosage/adverse effects
MH  - Calcium/*administration & dosage/adverse effects
MH  - *Contraceptives, Oral/adverse effects
MH  - Double-Blind Method
MH  - Estrogens/administration & dosage/adverse effects
MH  - Ethinyl Estradiol/administration & dosage/adverse effects
MH  - Female
MH  - Folic Acid/*blood
MH  - Glutamates/*administration & dosage/adverse effects
MH  - Homocysteine/*blood
MH  - Humans
MH  - Mineralocorticoid Receptor Antagonists/administration & dosage/adverse effects
MH  - Neural Tube Defects/*prevention & control
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2011/11/10 06:00
MHDA- 2012/04/07 06:00
CRDT- 2011/11/10 06:00
PHST- 2010/12/09 00:00 [received]
PHST- 2011/05/18 00:00 [revised]
PHST- 2011/05/20 00:00 [accepted]
PHST- 2011/11/10 06:00 [entrez]
PHST- 2011/11/10 06:00 [pubmed]
PHST- 2012/04/07 06:00 [medline]
AID - S0010-7824(11)00246-0 [pii]
AID - 10.1016/j.contraception.2011.05.013 [doi]
PST - ppublish
SO  - Contraception. 2012 Jan;85(1):42-50. doi: 10.1016/j.contraception.2011.05.013. 
      Epub 2011 Jul 13.