Trial Review

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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
Sex
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
1/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
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
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
[email protected]
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
[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.