Multi-Center, Randomized, Double-Blind Active-Controlled, Parallel Group Study to Investigate Plasma Folate, Red Blood Cell Folate and Homocysteine Levels During a 24 Week Oral Administration of an OC Containing Folate Compared to OC Alone

NCT00468481 Phase 3 COMPLETED Results posted

The purpose of this study is to determine whether the study drug is safe and effective

Details

Lead sponsor	Bayer
Phase	Phase 3
Status	COMPLETED
Enrolment	385
Start date	2007-04
Completion	2008-09

Conditions

• Neural Tube Defects
• Contraception
• Oral Contraceptives (OC)

Interventions

• Drospirenone/Ethinylestradiol/Methyltetrahydrofolate
• Drospirenone/Ethinylestradiol (Yaz)

Primary outcomes

• Red Blood Cell (RBC) Folate Level at 24 Weeks — Week 24
  RBC folate=(\[whole blood folate\*100\]-\[plasma folate\*(100-hematocrit)\])/hematocrit
• Plasma Folate Level at 24 Weeks — Week 24
  Folate concentrations in plasma were determined by an appropriately validated microbiological assay.

Countries

United States