NCT00821496

Evaluate the Effect of VI-0521 on the Pharmacokinetics of Oral Contraceptive in Healthy Female Subjects

A Phase I, Open Label, Fixed Sequence, Single-Center Study to Evaluate the Effect of Multiple Dose Administration of VI-0521 on the Pharmacokinetics of a Single Dose of Oral Contraceptive in Healthy Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: Female
• Age: 19 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study is desgigned to look at the effect of multiple dosing administration of VI-0521 on Oral Contraceptive medication.

Detailed description

This study is designed to determine if multiple oral doses of VI-0521 would alter the pharmacokinetics of an oral contraceptive in healthy female subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ethinyl estradiol, norethindrone, VI-0521	Oral contraceptive

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2009-01-13
• Last updated: 2009-12-02

Locations

1 site across 1 country: United States