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

NCT00821496 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-12-02

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

ethinyl estradiol, norethindrone, VI-0521

Oral contraceptive

Sponsors & Collaborators

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Shiyin Yee · VIVUS LLC

  • Scott Sharples, M.D. · MDS Pharma Services

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-03-31
Completion
2009-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00821496 on ClinicalTrials.gov