NCT00468481

Efficacy and Safety Study for an Oral Contraceptive Containing Folate

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 385 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Acronym is used in result section: suspected/diagnosed (susp/diag)

Conditions

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

Interventions

Type	Name	Description
DRUG	Drospirenone/Ethinylestradiol/Methyltetrahydrofolate	0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF)
DRUG	Drospirenone/Ethinylestradiol (Yaz)	0.020 mg ethinylestradiol with 3.0 mg drospirenone

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-08-01
• Completion: 2008-09-01
• First posted: 2007-05-02
• Last updated: 2014-04-23
• Results posted: 2011-01-25

Locations

9 sites across 1 country: United States