Assessment of the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and Comparison of the Folate Metabolites During the 24 Weeks of Treatment (Yasmin + Metafolin Versus Yasmin + Folic Acid) Followed by a 20 Week Elimination Phase of Folate

Phase 1 Completed 172 enrolled Bayer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to examine and compare the uptake of levomefolate calcium (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of treatment with a following folate elimination phase of 20 weeks in healthy volunteers seeking contraception. Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) was co-administered over the entire period of 44 weeks.

Timeline

Start: 2006-12
Primary completion: 2008-01
Completion: 2008-01

Publications

Results 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. doi: 10.2147/IJWH.S37254. Print 2013.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	folic acid	Other / unclassified	0.4 mg	Oral
Subject	levomefolate calcium	Unknown	0.451 mg	Oral
Background	drospirenone	Unknown	3 mg	Oral
Background	ethinyl estradiol	Small molecule	0.03 mg	Oral

Indications

No indication recorded.