Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000154202
Ethics application status
Approved
Date submitted
24/02/2009
Date registered
18/03/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Oestrogen cream or a simple lubricant to treat vaginal dryness in women on Arimidex treatment for breast cancer
Scientific title
A randomised, open-label, comparative, mult-centre trial to test the efficacy and systemic absorption of vaginal estradiol or estriol compared with a non-hormonal preparation in postmenopausal breast cancer patients with symptomatic atrophic vaginitis using the aromatase inhibitor, anastrozole
Secondary ID [1] 273200 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 4377 0
Atrophic vaginitis 4378 0
Condition category
Condition code
Cancer 4622 4622 0 0
Breast
Renal and Urogenital 4623 4623 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ovestin 0.5mg vaginally, daily for 2 weeks then twice weekly for 10 weeks. Vagifem 25mcg vaginally, daily for 2 weeks then twice daily for 10 weeks
Intervention code [1] 4109 0
Treatment: Drugs
Comparator / control treatment
Non hormonal lubricant "Replens". vaginally 3 times per week for 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 5494 0
To compare the changes in serum oestradiol levels over 12 weeks between patients randomised to 17-beta oestradiol (vagifem), vaginal estriol (ovestin) and non-hormonal lubricant (replens)
This outcome will be assessed by repeated highly sensitive serum estradiol levels taken prior to treatment then whilst on treatment.
Timepoint [1] 5494 0
A measurement will be taken prior to commencement of treatment and following commencement of treatment at 2 weeks, 6 weeks and 12 weeks.
Secondary outcome [1] 9256 0
To measure changes in vaginal pH.
This outcome will be assessed clinically with a measurement of vaginal pH.
Timepoint [1] 9256 0
A measurement will be taken prior to commencement of treatment and following commencement of treatment at 2 weeks, 6 weeks and 12 weeks
Secondary outcome [2] 241513 0
Measure changes in vaginal maturation index. The vaginal maturation index will be analysed at a local laboratory.
Timepoint [2] 241513 0
A measurement will be taken prior to commencement of treatment and following commencement of treatment at 2 weeks, 6 weeks and 12 weeks.
Secondary outcome [3] 241514 0
To assess symptoms of atrophic vaginitis. This assessement of symptoms will be performed by health care professionals.
Timepoint [3] 241514 0
An assessment will be performed prior to commencement of treatment and following commencement of treatment at 2 weeks, 6 weeks and 12 weeks.
Secondary outcome [4] 241515 0
Evaluate quality of life using the Functional Assessment of Cancer Therapy for Breast Cancer Patients Questionnaire (FACT-B).
Timepoint [4] 241515 0
The questionnaire will be completed prior to commencement of treatment and following commencement of treatment at 2 weeks, 6 weeks and 12 weeks.
Secondary outcome [5] 241516 0
Evaluate sexual function using the Sexual Activity Questionnaire. (Thirlaway 1996)
Timepoint [5] 241516 0
The questionnaire will be completed prior to commencement of treatment and following commencement of treatment at 2 weeks, 6 weeks and 12 weeks.
Secondary outcome [6] 241517 0
Evaluate endocrine symptoms in breast cancer patients using the Functional Assessment of Cancer Therapy - Endocrine Symptoms Questionnaire (FACT-ES).
Timepoint [6] 241517 0
The questionnaire will be completed prior to commencement of treatment and following commencement of treatment at 2 weeks, 6 weeks and 12 weeks.
Secondary outcome [7] 241518 0
Evaluate menopause symptoms using the Menopause Quality of Life Questionnaire.
Timepoint [7] 241518 0
The questionnaire will be completed prior to commencement of treatment and following commencement of treatment at 2 weeks, 6 weeks and 12 weeks.

Eligibility
Key inclusion criteria
History of oestrogen receptor positive breast cancer.
Post menopausal.
Taking anastrozole 1 mg orally once a day for at least 6 weeks.
Symptoms of atrophic vaginitis (vaginal dryness, discomfort, pruritis, dyspareunia, urinary tract infections and urinary urgency) and requesting treatment for these.
Willing to be randomised.
Scoring at least 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of advanced breast cancer
Taking systemic oestrogens, tamoxifin or tibolone in previous 6 weeks
Current vaginal infection
Postmenopausal bleeding
History of endometrial hyperplasia or endometrial cancer
Using other vulval or vaginal preparations
Abnormal cervical smear, carcinoma in situ, invasive carcinoma at screening

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)
Allocation concealment. Sealed numbered opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
16/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 1522 0
6000

Funding & Sponsors
Funding source category [1] 4552 0
Commercial sector/Industry
Name [1] 4552 0
Astra Zeneca PTY LTD
Country [1] 4552 0
Australia
Primary sponsor type
University
Name
School of Women's and Infants' Health
Address
374 Bagot Road
Subiaco 6008
Western Australia
Country
Australia
Secondary sponsor category [1] 4108 0
None
Name [1] 4108 0
Address [1] 4108 0
Country [1] 4108 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6602 0
King Edward Hospital Ethics Committee
Ethics committee address [1] 6602 0
Roberts Road
Subiaco 6008
Western Australia
Ethics committee country [1] 6602 0
Australia
Date submitted for ethics approval [1] 6602 0
Approval date [1] 6602 0
01/07/2008
Ethics approval number [1] 6602 0
1546/EW

Summary
Brief summary
This study looks at the use of oestrogen cream or a simple lubricant to treat vaginal dryness in women on Arimidex for breast cancer.
The aim of the study is to objectively measure vaginal atrophy in symptomatic breast cancer patients taking Arimidex and to compare the effectiveness, local vaginal effects and systemic absorption of 17-beta oestradiol (vagifem) with vaginal estriol (ovestin) and a non-hormonal lubricant, Replens. In addition we will evaluate quality of life and sexual function before and after use of topical oestrogen or replens. Eighty four postmenopausal women will be recruited from menopause, breast and oncology clinics in New South Wales and Western Australia. To participate women must have a history of estrogen-receptor positive breast cancer, postmenopausal, taking Arimidex for at least 6 weeks and complaining of symptoms of atrophic vaginitis. Patients will be asked to attend 4 clinic visits over a total of 4 months. All particiapnts will be monitored at 2, 6 and 12 weeks following the start of treatment and the changes in their serum oestradiol levels will be recorded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29319 0
Address 29319 0
Country 29319 0
Phone 29319 0
Fax 29319 0
Email 29319 0
Contact person for public queries
Name 12566 0
Lee Ann Mahoney
Address 12566 0
School of Women's and Infants' Health
1st Floor Carson House
374 Bagot Road
Subiaco 6008
Western Australia
Country 12566 0
Australia
Phone 12566 0
+61 8 93402717
Fax 12566 0
+61 8 93401319
Email 12566 0
[email protected]
Contact person for scientific queries
Name 3494 0
Professor Martha Hickey
Address 3494 0
School of Women's and Infants' Health
374 Bagot Road
Subiaco 6008
Western Australia
Country 3494 0
Australia
Phone 3494 0
+61 8 93401331
Fax 3494 0
Email 3494 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

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