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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000154202

Enrollment

Registered

2009-03-18

Start date

2009-02-16

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Yes

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

Outcome results