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SPL7013 Gel - Male Tolerance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00370357
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : January 16, 2008
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
Starpharma Pty Ltd

Tracking Information
First Submitted Date  ICMJE August 30, 2006
First Posted Date  ICMJE August 31, 2006
Last Update Posted Date January 16, 2008
Study Start Date  ICMJE August 2006
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2006)
  • 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 Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2006)
  • 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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Human Immunodeficiency Virus (HIV)
Intervention  ICMJE Drug: 3% w/w SPL7013 Gel (VivaGel™)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 30, 2006)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00370357
Other Study ID Numbers  ICMJE SPL7013-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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
PRS Account 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