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Trial registered on ANZCTR


Registration number
ACTRN12606000020583
Ethics application status
Approved
Date submitted
11/01/2006
Date registered
13/01/2006
Date last updated
13/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phyto-Soya Vaginal Gel Study
Scientific title
A randomized controll trial of Phyto-Soya Vaginal Gel for the relief of memopausal Vaginal Atrophy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopausal Vaginal Atrophy 981 0
Condition category
Condition code
Reproductive Health and Childbirth 1056 1056 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group would be women randomised into a group that will receive the Phy-Soya Vaginal Gel and
Intervention code [1] 834 0
None
Comparator / control treatment
the control group would be include women randomised into a group that will receive the placebo.
Control group
Placebo

Outcomes
Primary outcome [1] 1411 0
To evaluate the efficacy of Phyto-Soya vaginal gel in decreasing the severity of vaginal dryness of postmenopausal women by measuring symptoms questionnaires
Timepoint [1] 1411 0
At weeks 4 and week 8 of the treatment.
Primary outcome [2] 1412 0
To evaluate the efficacy of Phyto-Soya vaginal gel in decreasing the severity of vaginal/vulval itching of postmenopausal women by measuring symptoms questionnaires
Timepoint [2] 1412 0
At weeks 4 and week 8 of the treatment.
Primary outcome [3] 1413 0
To evaluate the efficacy of Phyto-Soya vaginal gel in decreasing the severity of dyspareunia of postmenopausal women by measuring symptoms questionnaires
Timepoint [3] 1413 0
At weeks 4 and week 8 of the treatment.
Secondary outcome [1] 2499 0
Measuring vaginal pH and vaginal Maturation Index
Timepoint [1] 2499 0
At 4 weeks and 8 weeks of the treatment.

Eligibility
Key inclusion criteria
Postmenopausal woman and one of the following:Vaginal dryness, vaginal itching, Painful sexual intercourse, Vaginal pH >5 at screening.
Minimum age
40 Years
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Systemic or topical oestrogens within 8 weeks. effective menopausal herbals within 4 weeks, Vulval dystrophy, Current vaginal or urinary tract infection, Any vaginal surgery within 12 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Coded medication container
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised by computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1156 0
Self funded/Unfunded
Name [1] 1156 0
Address [1] 1156 0
Country [1] 1156 0
Primary sponsor type
Commercial sector/Industry
Name
Arkopharma Australia
Address
Country
Australia
Secondary sponsor category [1] 1015 0
None
Name [1] 1015 0
no
Address [1] 1015 0
Country [1] 1015 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35716 0
Address 35716 0
Country 35716 0
Phone 35716 0
Fax 35716 0
Email 35716 0
Contact person for public queries
Name 10023 0
Associate Professor John Eden
Address 10023 0
Sydney Menopause Centre
Royal Hospital for Women
Level 0
Barker Street
Randwick NSW 2031
Country 10023 0
Australia
Phone 10023 0
+61 2 93826777
Fax 10023 0
Email 10023 0
j.eden@unsw.edu.au
Contact person for scientific queries
Name 951 0
Ms Jinzhu Liu
Address 951 0
Sydney Menopause Centre
Royal Hospital for Women
Level 0
Barker Street
Randwick NSW 2031
Country 951 0
Australia
Phone 951 0
+61 2 93826702
Fax 951 0
Email 951 0
jz.liu@unsw.edu.au

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