SPL7013 Gel - Male Tolerance Study

This study has been completed.

Sponsor:

Collaborator:

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by:

Starpharma Pty Ltd

ClinicalTrials.gov Identifier:

NCT00370357

First received: August 30, 2006

Last updated: January 10, 2008

Last verified: January 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

August 30, 2006

Last Updated Date

January 10, 2008

Start Date ^ICMJE

August 2006

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Participant reports of genital pain, genital burning, penile itching, penile rash, penile ulceration or other genital symptoms
Erythema, vesiculation, bullous reaction, ulceration or other genital findings of the penile shaft, foreskin, glans or meatus as observed by visual examination

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00370357 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

All other adverse events
Laboratory abnormalities
Plasma concentrations of SPL7013
Expectations and experiences of the study products described by participant interviews

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

SPL7013 Gel - Male Tolerance Study

Official Title ^ICMJE

A Phase 1, Placebo Controlled Study of the Safety of 3% w/w SPL7013 Gel, Administered to the Penis of Healthy Male Volunteers Once Daily for Seven Days

Brief Summary

The purpose of this study is to determine if SPL7013 Gel (VivaGel™) is safe when applied topically once a day for seven consecutive days to the shaft and glans of the penis in healthy male volunteers. The study will compare the safety of SPL7013 Gel on the penile epithelium and urethral mucosa to the safety of a placebo gel. The study will also assess the systemic safety of SPL7013 Gel, systemic absorption of the active ingredient of SPL7013 Gel, and the acceptability of the study products to the male volunteers.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Condition ^ICMJE

Human Immunodeficiency Virus (HIV)

Intervention ^ICMJE

Drug: 3% w/w SPL7013 Gel (VivaGel™)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

February 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Provision of written informed consent
Healthy males aged 18 years or older
HIV negative
Reports vaginal intercourse in the past 12 months
Agrees to abstain from vaginal, anal (receptive and insertive) and oral sexual intercourse, and agrees to refrain from masturbation during the 7 days of product use until after the End-of-Treatment (Day 7) study visit

Exclusion Criteria:

Known or suspected allergy to any component of the study products or similar ingredients in other products
History of significant drug reaction or allergy
Recent history (within 12 months) or presence at screening of contact dermatitis or other dermatological condition
Recent history (within three months of Screening) of a sexually transmitted infection (STI)
Current signs or symptoms of UTI and/or STI at Screening or Baseline
Positive urine leukocyte esterase test (≥ trace)
Biochemical and/or haematological parameters outside the laboratory's normal reference ranges at Screening
Evidence of genital piercing, ulceration, genital dermatoses, tinea cruris or other dermatological condition of the genitalia or upper thighs
Genital pain or discomfort at Screening or Baseline
Any other abnormal finding on physical examination or other medical condition

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00370357

Other Study ID Numbers ^ICMJE

SPL7013-002

Has Data Monitoring Committee

Not Provided

Responsible Party

Marcus Chen MD, Melbourne Sexual Health Clinic

Study Sponsor ^ICMJE

Starpharma Pty Ltd

Collaborators ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators ^ICMJE

Principal Investigator:

Marcus Chen, MD, PhD

Melbourne Sexual Health Centre

Information Provided By

Starpharma Pty Ltd

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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