SPL7013 Gel - Male Tolerance Study

Starpharma

Status and phase

Completed

Phase 1

Conditions

Human Immunodeficiency Virus (HIV)

Treatments

Drug: 3% w/w SPL7013 Gel (VivaGel™)

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT00370357

SPL7013-002

Details and patient eligibility

About

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.

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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