Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)

Last updated: September 24, 2015
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

3

Condition

Cervical Intraepithelial Neoplasia

Warts

Sexually Transmitted Diseases (Stds)

Treatment

N/A

Clinical Study ID

NCT00092521
V501-013
2004_081
  • Ages 16-23
  • Female
  • Accepts Healthy Volunteers

Study Summary

The primary purpose of the study is to determine if GARDASIL (V501) with four components is able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion

Exclusion Criteria:

  • Prior Human Papillomavirus (HPV) vaccination

  • Prior abnormal paps

  • History of genital warts

Study Design

Total Participants: 5759
Study Start date:
December 01, 2001
Estimated Completion Date:
January 31, 2009