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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

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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) Drug: 3% w/w SPL7013 Gel (VivaGel™) Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
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
Study Start Date : August 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Participant reports of genital pain, genital burning, penile itching, penile rash, penile ulceration or other genital symptoms
  2. 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 :
  1. All other adverse events
  2. Laboratory abnormalities
  3. Plasma concentrations of SPL7013
  4. Expectations and experiences of the study products described by participant interviews

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00370357

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Australia, Victoria
Melbourne Sexual Health Centre
Carlton, Victoria, Australia, 3053
Sponsors and Collaborators
Starpharma Pty Ltd
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Marcus Chen, MD, PhD Melbourne Sexual Health Centre

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Responsible Party: Marcus Chen MD, Melbourne Sexual Health Clinic Identifier: NCT00370357    
Other Study ID Numbers: SPL7013-002
First Posted: August 31, 2006    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008
Keywords provided by Starpharma Pty Ltd:
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases