An Investigational Study of Gardasil (V501) in Reducing the Incidence of Anogenital Warts in Young Men - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00090285

Purpose

This study is to evaluate an investigational vaccine with the following objectives: To demonstrate that the vaccine is well-tolerated in young men; To demonstrate that the vaccine reduces incidence of Condylomata Acuminata (anogenital warts) in young men; and To demonstrate that the vaccine reduces incidence of human papillomavirus (HPV) infection in young men.

Condition	Intervention	Phase
Condylomata Acuminata	Biological: (Gardasil) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine Biological: Comparator: placebo (unspecified)	Phase III

MedlinePlus related topics: Genital Warts Warts

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men

Further study details as provided by Merck:

Primary Outcome Measures:

Incidence of HPV related external genital warts, PIN, penile, perianal or perineal cancer. [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Persistent HPV 6, 11, 16, and 18 infection.; HPV 6, 11, 16, and 18 detection. [ Time Frame: Duration of Treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	2700
Study Start Date:	September 2004
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: (Gardasil) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine Duration of Treatment: 6 months
2: Placebo Comparator	Biological: Comparator: placebo (unspecified) Duration of Treatment: 6 months

Eligibility

Ages Eligible for Study:	16 Years to 26 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy males between the ages of 16 and 26
No known history of genital warts
Additional criteria will be discussed with you by the physician

Exclusion Criteria:

Female
Cannot have a history of known prior vaccination with an HPV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090285

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_103, Formerly-0904HPVHMES, V501-020
Study First Received:	August 25, 2004
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00090285
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

anogenital warts

Study placed in the following topic categories:

Virus Diseases
Skin Diseases, Infectious
Sexually Transmitted Diseases, Viral
Warts
Skin Diseases
Condyloma acuminatum

Condylomata Acuminata
Sexually Transmitted Diseases
Condyloma
DNA Virus Infections
Papillomavirus Infections

Additional relevant MeSH terms:

Skin Diseases, Viral
Tumor Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009