Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00370357