Clinical Trials


SPL7013 Gel - Male Tolerance Study

This study has been completed
Starpharma Pty Ltd

National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party)
Starpharma Pty Ltd Identifier

First received: August 30, 2006
Last updated: January 10, 2008
Last Verified: January 2008
History of Changes


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.

Condition Intervention Phase
Human Immunodeficiency Virus (HIV)

Drug : 3% w/w SPL7013 Gel (VivaGel™)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: 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

Further study details as provided by Starpharma Pty Ltd:

Primary Outcome Measures

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

Enrollment: 36
Study Start Date: August 2006
Study Completion Date: June 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)



Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  


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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00370357


Melbourne Sexual Health Centre
Carlton, Victoria, Australia, 3053

Sponsors and Collaborators

Starpharma Pty Ltd
National Institute of Allergy and Infectious Diseases (NIAID)


Principal Investigator: Marcus Chen, MD, PhD Melbourne Sexual Health Centre
More Information

More Information

Responsible Party: Marcus Chen MD, Melbourne Sexual Health Clinic Identifier: NCT00370357   History of Changes  
Other Study ID Numbers: SPL7013-002  
Study First Received: August 30, 2006  
Last Updated: January 10, 2008  

Keywords provided by Starpharma Pty Ltd:


Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections processed this data on July 20, 2018
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