生物活性

• 描述Levomefolate calcium is an artificial form of folate. It is a coenzymated form of folic acid and a more bioavailable alternative in dietary supplements. A fixed-dose combination of an oral contraceptive and levomefolate calcium leads to sustainable improvements in folate status compared with an oral contraceptive + folic acid^[3]. Clinically significant increases in folate status were observed with EE/drsp/levomefolate calcium compared with EE(ethinylestradiol)/drsp alone in US women of childbearing age^[4]. The rate and extent of absorption of ethinylestradiol and drospirenone were not affected by the concomitant administration of levomefolate calcium and vice versa^[5].
• 临床研究

• NCT号	适应症或疾病	临床期	招募状态	预计完成时间	地点
  NCT00468481	Neural Tube Defects ... more >> Contraception Oral Contraceptives (OC) Collapse <<	Phase 3	Completed	-	United States, California ... more >> Orange County Clinical Trials Anaheim, California, United States, 92801 Medical Center for Clinical Research San Diego, California, United States, 92108 United States, Maryland SNBL Clinical Pharmacology Center, Inc. Baltimore, Maryland, United States, 21201 United States, New York Columbia University Medical Center New York, New York, United States, 10032 United States, North Carolina AAIPharma, Inc. Morrisville, North Carolina, United States, 27560 Lyndhurst Gynecologic Associates Winston-Salem, North Carolina, United States, 27103 United States, South Carolina Coastal Carolina Research Center Mt. Pleasant, South Carolina, United States, 29464 United States, Tennessee New Orleans Center for Clinical Research Knoxville, Tennessee, United States, 37920 United States, Washington NorthWest Kinetics Tacoma, Washington, United States, 98418 Collapse <<
  NCT00468481	-	-	Completed	-	-
  NCT01584050	Vitamin B12 Deficiency	Not Applicable	Completed	-	Canada, British Columbia ... more >> University of British Columbia Vancouver, British Columbia, Canada Malaysia Universiti Putra Malaysia Serdang, Selangor, Malaysia Collapse <<

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• 参考文献

• [1] Wiesinger H, Eydeler U, et al. Bioequivalence evaluation of a folate-supplemented oral contraceptive containing ethinylestradiol/drospirenone/levomefolate calcium versus ethinylestradiol/drospirenone and levomefolate calcium alone. Clin Drug Investig. 2012 Oct 1;32(10):673-84.

  [2] Blode H, Klipping C, et al. Bioequivalence study of an oral contraceptive containing ethinylestradiol/drospirenone/levomefolate calcium relative to ethinylestradiol/drospirenone and to levomefolate calcium alone. Contraception. 2012 Feb;85(2):177-84.

  [3] Diefenbach K, Trummer D, Ebert F, Lissy M, Koch M, Rohde B, Blode H. EE-drospirenone-levomefolate calcium versus EE-drospirenone + folic acid: folate status during 24 weeks of treatment and over 20 weeks following treatment cessation. Int J Womens Health. 2013 Apr 11;5:149-63

  [4] Bart S Sr, Marr J, Diefenbach K, Trummer D, Sampson-Landers C. 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. Contraception. 2012 Jan;85(1):42-50

  [5] Blode H, Klipping C, Richard F, Trummer D, Rohde B, Diefenbach K. Bioequivalence study of an oral contraceptive containing ethinylestradiol/drospirenone/levomefolate calcium relative to ethinylestradiol/drospirenone and to levomefolate calcium alone. Contraception. 2012 Feb;85(2):177-84

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