Status:
COMPLETED
SPL7013 Gel - Male Tolerance Study
Lead Sponsor:
Starpharma Pty Ltd
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Human Immunodeficiency Virus (HIV)
Eligibility:
MALE
18+ years
Phase:
PHASE1
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00370357
Start Date
August 1 2006
End Date
June 1 2007
Last Update
January 16 2008
Active Locations (1)
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1
Melbourne Sexual Health Centre
Carlton, Victoria, Australia, 3053