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A Randomized, Double-Blind, Two-Part, Parallel-Group, Comparative Study to Evaluate Blood Folate Levels in Women Taking an Oral Contraceptive With and Without Folic Acid
The purpose of this study is to compare red blood cell folate levels in women who are taking oral contraceptives with or without folic acid
Details
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Phase | Phase 3 |
| Status | WITHDRAWN |
| Completion | 2004-12 |
Conditions
- Neural Tube Defects
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Nervous System Malformations
Interventions
- Norgestimate-ethinyl estradiol, with or without folic acid
Primary outcomes
- Part 1: Change in concentration of folate in red blood cells (RBC) from the start of the study to Cycle 4 (4 cycles of 28 days of treatment)