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Trial registered on ANZCTR


Registration number
ACTRN12617000778381
Ethics application status
Approved
Date submitted
25/05/2017
Date registered
29/05/2017
Date last updated
29/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and tolerability of a vaginal ointment without any active drugs in healthy women.
Scientific title
Study assessing the safety and tolerability of an intravaginal ointment containing oleic acid in healthy female volunteers.
Secondary ID [1] 292036 0
None
Universal Trial Number (UTN)
U1111-1195-9873
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical neoplasia and condyloma acuminatum 303428 0
Condition category
Condition code
Infection 302840 302840 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pilot study to investigate the safety and tolerability of a vaginal ointment that does not yet have any active ingredient. The study is being conducted to make sure it is a comfortable ointment to use in the vagina.

The ointment will be self-administered into the vagina, once daily for 21 days and a questionnaire will be used about its effects. Full instructions will be given as to its application. Participants will also be asked to provide a urine sample and vaginal swabs at various intervals throughout the study. The ointment will be given to participants to take home in pre-filled applicators along with the study questionnaires. A diary will be completed by each participant and each participant will sign upon each administration.

Pre and post study laboratory tests will be completed to assess the health of participants along with drugs of abuse testing. The intervention for this study is the ointment formulation of oleic acid.
Intervention code [1] 298163 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302233 0
The primary objective is to determine the safety and tolerability of the ointment. Assessed through a questionnaire and daily dairy. These forms have been specifically designed for this study.

Timepoint [1] 302233 0
Days 1-22, and average of the total scores from Day 2 to Day 8, Day 9 to Day 15, and Day 16 to Day 22 will be calculated.
Secondary outcome [1] 335247 0
None
Timepoint [1] 335247 0
None

Eligibility
Key inclusion criteria
Healthy non-pregnant females
Aged between 18 and 55
A normal atypical or low grade intraepithelial lesion on cervical smear in the preceding 12 months
BMI between 19 and 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
Able to provide written informed consent and willing to adhere to all study instructions and restrictions.
Minimum age
18 Years
Maximum age
55 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Concomitant drug therapy for any condition that is not well controlled or that might affect the vaginal mucosa.
Sensitivity to the study ointment
History of any clinically significant medical conditions
Clinically significant abnormality or abnormal laboratory test result found during medical screening
Females who are pregnant and/or are breastfeeding
History of alcohol or drug abuse or dependency
Participation in a drug study within 30 days of the start of the study
Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
This is an interventional study assessing the safety and tolerability involving 12 participants with the aim of having at least 10 participants complete. No statistical methods have been employed in the calculation of the sample size.

Demographic parameters will be summarised descriptively, as well as treatment-emergent AEs by treatment in the safety population. No inferential statistical analysis is planned for safety data. Summary statistics will also be presented from the tabulated answers in the questionnaires. The summary statistics will be interpreted. No inferential statistical analysis is planned for tolerability data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8917 0
New Zealand
State/province [1] 8917 0
Otago

Funding & Sponsors
Funding source category [1] 296568 0
Commercial sector/Industry
Name [1] 296568 0
Douglas Pharmaceuticals Limited
Address [1] 296568 0
Central Park Drive
Auckland 0651
Country [1] 296568 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
156 Frederick St
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 295518 0
None
Name [1] 295518 0
Address [1] 295518 0
Country [1] 295518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297784 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 297784 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 297784 0
New Zealand
Date submitted for ethics approval [1] 297784 0
27/04/2017
Approval date [1] 297784 0
19/05/2017
Ethics approval number [1] 297784 0
17/STH/74

Summary
Brief summary
The objective of this study is to evaluate the safety and tolerability of a 21 day treatment of self-administered vaginal ointment vehicle containing oleic acid.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75102 0
Dr Noelyn Hung
Address 75102 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 75102 0
New Zealand
Phone 75102 0
+6434779669
Fax 75102 0
+6434779605
Email 75102 0
noelyn.hung@otago.ac.nz
Contact person for public queries
Name 75103 0
Mrs Linda Folland
Address 75103 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 75103 0
New Zealand
Phone 75103 0
+6434779669
Fax 75103 0
+6434779605
Email 75103 0
linda.folland@zenithtechnology.co.nz
Contact person for scientific queries
Name 75104 0
Dr Cheung-Tak Hung
Address 75104 0
Zenith Technology Corporation Limited
156 Frederick Street (PO Box 1777)
Dunedin 9016
Country 75104 0
New Zealand
Phone 75104 0
+6434779669
Fax 75104 0
+6434779605
Email 75104 0
tak.hung@zenithtechnology.co.nz

No data has been provided for results reporting
Summary results
Not applicable