Clinical trial
Efficacy and Safety Study for an Oral Contraceptive Containing Folate
NCT00468481 · Bayer, Industry · Completed
Key facts
| NCT number | NCT00468481 |
|---|---|
| Title | Efficacy and Safety Study for an Oral Contraceptive Containing Folate |
| Official title | 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 |
| Lead sponsor | Bayer, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Neural Tube Defects, Contraception, Oral Contraceptives (OC) |
| Intervention type | Drug |
| Interventions | Drospirenone/Ethinylestradiol/Methyltetrahydrofolate, Drospirenone/Ethinylestradiol (Yaz) |
| Enrollment | 385 |
| Start date | Apr 1, 2007 |
| Primary completion | Aug 1, 2008 |
| Completion | Sep 1, 2008 |
| First posted | May 2, 2007 |
| Last update posted | Apr 23, 2014 |
| Countries | United States |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: