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

August 30, 2006
August 31, 2006
January 16, 2008
August 2006
February 2007   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT00370357 on Archive Site
  • All other adverse events
  • Laboratory abnormalities
  • Plasma concentrations of SPL7013
  • Expectations and experiences of the study products described by participant interviews
Same as current
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SPL7013 Gel - Male Tolerance Study
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
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.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Human Immunodeficiency Virus (HIV)
Drug: 3% w/w SPL7013 Gel (VivaGel™)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2007
February 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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Marcus Chen MD, Melbourne Sexual Health Clinic
Starpharma Pty Ltd
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Marcus Chen, MD, PhD Melbourne Sexual Health Centre
Starpharma Pty Ltd
January 2008

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