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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00370357




Registration number
NCT00370357
Ethics application status
Date submitted
30/08/2006
Date registered
31/08/2006
Date last updated
16/01/2008

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 Once Daily for Seven Days
Secondary ID [1] 0 0
SPL7013-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus (HIV) 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 3% w/w SPL7013 Gel (VivaGel™)

Treatment: Drugs: 3% w/w SPL7013 Gel (VivaGel™)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participant reports of genital pain, genital burning, penile itching, penile rash, penile ulceration or other genital symptoms
Timepoint [1] 0 0
Primary outcome [2] 0 0
Erythema, vesiculation, bullous reaction, ulceration or other genital findings of the penile shaft, foreskin, glans or meatus as observed by visual examination
Timepoint [2] 0 0
Secondary outcome [1] 0 0
All other adverse events
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Laboratory abnormalities
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Plasma concentrations of SPL7013
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Expectations and experiences of the study products described by participant interviews
Timepoint [4] 0 0

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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Sexual Health Centre - Carlton
Recruitment postcode(s) [1] 0 0
3053 - Carlton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Starpharma Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Allergy and Infectious Diseases (NIAID)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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
https://clinicaltrials.gov/ct2/show/NCT00370357
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marcus Chen, MD, PhD
Address 0 0
Melbourne Sexual Health Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00370357