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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000385549

Acronym

Starpharma Protocol Number SPL7013-002

Enrollment

Registered

2006-09-01

Start date

2006-08-24

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

2 grams of 3% SPL7013 Gel (VivaGel™) administered topically to the penis, once daily for seven days.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1.Provision of written informed consent. 2.HIV negative as documented by licensed ELISA at Screening. 3.Agree to abstain from vaginal, anal (receptive and insertive) and oral sexual intercourse until after the End-of-Treatment (Day 7) study visit. 4.Has reported vaginal intercourse occurring in the past 12 months.

Exclusion criteria

1.Known or suspected allergy to any component of the study products or similar ingredients in other products. 2.History of significant drug reaction or allergy. 3.Recent history (within 12 months) or presence at screening of contact dermatitis or other dermatological condition. 4.Recent history (within three months of Screening) of a sexually transmitted infection (STI). 5.Current signs or symptoms of urinary tract infection (UTI) and/or STI at Screening or Baseline. 6.Positive urine leukocyte esterase test (= trace). 7.Biochemical and/or haematological parameters outside the laboratory's normal reference ranges at Screening. 8.Evidence of genital piercing, ulceration, genital dermatoses, tinea cruris or other dermatological condition of the genitalia or upper thighs. 9.Genital pain or discomfort at Screening or Baseline. 10.Any other abnormal finding on physical examination or other medical condition.

Outcome results