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An Open-label Pharmacokinetic Drug Interaction Study of Folic Acid and 250 Mcg NGM/35 Mcg E E (ORTHO-CYCLEN) in Healthy Women.
The purpose of the study is to assess the effect of folic acid administration on the blood level and the breakdown products of oral contraceptive (OC) \[250 mcg NGM/35 mcg EE\] tablets.
Details
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 47 |
| Start date | 2005-01 |
| Completion | 2005-02 |
Conditions
- Drug Interactions
- Contraception
- Pharmacokinetics
Interventions
- Norgestimate; Ethinyl Estradiol; Folic acid
Primary outcomes
- Evaluate the pharmacokinetic drug interaction between folic acid and OC (250 mcg NGM and 35 mcg EE) as measured by the pharmacokinetics of the active breakdown products of NGM, (norelgestromin [NGMN], and norgestrel [NG]) and EE.