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NCT00092534CompletedPhase 3

Cervical Intraepithelial Neoplasm (CIN) in Women (Gardasil) (V501-015)

A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Immunogenicity, and Efficacy on the Incidence of HPV 16/18-Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year Old Women - The FUTURE II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)

Source: ClinicalTrials.gov · Last updated 1 Aug 2025

Brief summary (registry, in English)

The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent cervical cancer.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
12167 (actual)
First submitted
23 Sept 2004
Start date
14 Jun 2002
Primary completion date
31 Jul 2007
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT00092534

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 12167
  • From 14 Jun 2002 to the primary completion date, 31 Jul 2007
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior Human Papilloma Virus (HPV) vaccination
  • Prior abnormal Paps
  • Prior history of genital warts
    • --For Extension Phase:
  • Prior complete HPV vaccination series

Age

  • Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil
    • --For LTFU Study:

Other

  • There were no exclusion criteria that did not overlap the inclusion criteria for this study.

Who the study is looking for

  • Healthy women with an intact uterus with lifetime history of 0-4 sexual partners
    • --For Extension Phase:
  • Participant received placebo or an incomplete vaccination series in the original study
    • --For LTFU:
  • Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden.
  • Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection

Age in the registry: 16 years to 23 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.