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Trial registered on ANZCTR


Registration number
ACTRN12606000385549
Ethics application status
Approved
Date submitted
30/08/2006
Date registered
1/09/2006
Date last updated
14/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
SPL7013 Gel - Male Tolerance Study
Scientific title
A Phase 1, Placebo Controlled Study of the Safety of 3% w/w SPL7013 Gel Administered to the Penis of Healthy Male Volunteers
Universal Trial Number (UTN)
Trial acronym
Starpharma Protocol Number SPL7013-002
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Safety for HIV preventive product 1351 0
Condition category
Condition code
Other 1441 1441 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 grams of 3% SPL7013 Gel (VivaGel™) administered topically to the penis, once daily for seven days.
Intervention code [1] 1336 0
Prevention
Comparator / control treatment
2 grams of placebo gel administered topically to the penis, once daily for seven days.
Control group
Placebo

Outcomes
Primary outcome [1] 1980 0
Participant reports of genital pain
Timepoint [1] 1980 0
Measured at the baseline (Day 0) visit, then at mid-treatment (Day 3), end-of-treatment (Day 7) and 1 week post treatment (Day 14) visits.
Primary outcome [2] 1981 0
Participant reports of genital burning
Timepoint [2] 1981 0
Measured at the baseline (Day 0) visit, then at mid-treatment (Day 3), end-of-treatment (Day 7) and 1 week post treatment (Day 14) visits.
Primary outcome [3] 1982 0
Participant reports of penile itching
Timepoint [3] 1982 0
Measured at the baseline (Day 0) visit, then at mid-treatment (Day 3), end-of-treatment (Day 7) and 1 week post treatment (Day 14) visits.
Primary outcome [4] 1983 0
Participant reports of penile rash
Timepoint [4] 1983 0
Measured at the baseline (Day 0) visit, then at mid-treatment (Day 3), end-of-treatment (Day 7) and 1 week post treatment (Day 14) visits.
Primary outcome [5] 1984 0
Participant reports of penile ulceration
Timepoint [5] 1984 0
Measured at the baseline (Day 0) visit, then at mid-treatment (Day 3), end-of-treatment (Day 7) and 1 week post treatment (Day 14) visits.
Primary outcome [6] 1985 0
Participant reports of other genital symptoms
Timepoint [6] 1985 0
Measured at the baseline (Day 0) visit, then at mid-treatment (Day 3), end-of-treatment (Day 7) and 1 week post treatment (Day 14) visits.
Primary outcome [7] 1986 0
Participant reports of other genital symptoms including Erythema as observed by visual examination
Timepoint [7] 1986 0
Measured at the baseline (Day 0) visit, then at mid-treatment (Day 3), end-of-treatment (Day 7) and 1 week post treatment (Day 14) visits.
Primary outcome [8] 1987 0
Participant reports of other genital symptoms including vesiculation as observed by visual examination
Timepoint [8] 1987 0
Measured at the baseline (Day 0) visit, then at mid-treatment (Day 3), end-of-treatment (Day 7) and 1 week post treatment (Day 14) visits.
Primary outcome [9] 1988 0
Participant reports of other genital symptoms including bullous reaction as observed by visual examination
Timepoint [9] 1988 0
Measured at the baseline (Day 0) visit, then at mid-treatment (Day 3), end-of-treatment (Day 7) and 1 week post treatment (Day 14) visits.
Primary outcome [10] 1989 0
Participant reports of other genital symptoms including ulceration as observed by visual examination
Timepoint [10] 1989 0
Measured at the baseline (Day 0) visit, then at mid-treatment (Day 3), end-of-treatment (Day 7) and 1 week post treatment (Day 14) visits.
Primary outcome [11] 1990 0
Participant reports of other genital symptoms including ulceration or other genital findings of the penile shaft, foreskin, glans or meatus as observed by visual examination
Timepoint [11] 1990 0
Measured at the baseline (Day 0) visit, then at mid-treatment (Day 3), end-of-treatment (Day 7) and 1 week post treatment (Day 14) visits.
Secondary outcome [1] 3449 0
All other adverse events
Timepoint [1] 3449 0
Day 0, Day 3, Day 7 and Day 14 visits.
Secondary outcome [2] 3450 0
Laboratory abnormalities
Timepoint [2] 3450 0
Day 0, Day 3, Day 7 and Day 14 visits.
Secondary outcome [3] 3451 0
Plasma concentrations of 3% w/w SPL7013
Timepoint [3] 3451 0
Day 0, Day 7 and Day 14 visits.
Secondary outcome [4] 3452 0
Expectations and experiences of the study products described by participant interviews
Timepoint [4] 3452 0
Day 0 and Day 7 visits.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered boxes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified based on circumcision status, then random assignment according to a computer-generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects, study staff, investigators, sponsor staff, interviewers will be blinded
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1580 0
Government body
Name [1] 1580 0
National Institute of Allergy and Infectious Diseases
Country [1] 1580 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Starpharma Pty Ltd
Address
Baker Building, 75 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 1387 0
Government body
Name [1] 1387 0
National Institute of Allergy and Infectious Diseases
Address [1] 1387 0
Bethesda, MD USA
Country [1] 1387 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3005 0
The Alfred Hospital Ethics Committee-Melbourne Sexual Health Centre
Ethics committee address [1] 3005 0
Ethics committee country [1] 3005 0
Australia
Date submitted for ethics approval [1] 3005 0
Approval date [1] 3005 0
30/05/2006
Ethics approval number [1] 3005 0
79/06

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27943 0
Address 27943 0
Country 27943 0
Phone 27943 0
Fax 27943 0
Email 27943 0
Contact person for public queries
Name 10525 0
Julie Silvers
Address 10525 0
Melbourne Sexual Health Centre
580 Swanston St
Carlton VIC 3053
Country 10525 0
Australia
Phone 10525 0
+61 3 93416260
Fax 10525 0
Email 10525 0
[email protected]
Contact person for scientific queries
Name 1453 0
Marcus Chen PhD
Address 1453 0
Melbourne Sexual Health Centre
580 Swanston St
Carlton VIC 3053
Country 1453 0
Australia
Phone 1453 0
+61 3 93416260
Fax 1453 0
Email 1453 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.