Oestrogen cream or a simple lubricant to treat vaginal dryness in women on Arimidex treatment for breast cancer

Phase 4

• Conditions: Breast cancer; Atrophic vaginitis; Cancer - Breast; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12609000154202
• Lead Sponsor: School of Women's and Infants' Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 84

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>This outcome will be assessed by repeated highly sensitive serum estradiol levels taken prior to treatment then whilst on treatment.[A measurement will be taken prior to commencement of treatment and following commencement of treatment at 2 weeks, 6 weeks and 12 weeks.]