None listed
Conditions
Brief summary
This study will investigate the feasibility of using oestradiol vaginal tablets (Vagifem Low) for women on adjuvant aromatase inhibitors for breast cancer Who is it for? You may be eligible to join this study if you are female, aged 18 and above, have early breast cancer (stage I-III), on an aromatase inhibitor for at least 3 months and are experiencing genitourinary symtoms Study details All participants in this study receive estradiol vaginal pessaries (Vagifem Low) for 12 weeks (daily application for the first 14 days, then twice a week application for the next ten weeks). Feasibility/adherence to treatment will be assessed using a participant diary. This study will also assess symptom response, quality of life and sexual function using questionnaires and the effect of this treatment on blood levels of oestrogen. We hope this study will further medical knowledge and may improve treatment of genitourinary symptoms for women in the future.
Interventions
Vagifem Low 10 mcg (estradiol vaginal inserts) are small, white, film-coated tablets containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. Each Vagifem Low tablet is 6 mm in diameter and is placed in a disposable applicator. Each tablet-filled applicator is packaged separately in a blister pack.
Oestradiol 10mcg vaginal pessaries (Vagifem Low) will be inserted by the participant, using an applicator, daily for the first 14 days, then twice weekly for 10 weeks (total tre
Vagifem Low 10 mcg (estradiol vaginal inserts) are small, white, film-coated tablets containing 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol. Each Vagifem Low tablet is 6 mm in diameter and is placed in a disposable applicator. Each tablet-filled applicator is packaged separately in a blister pack. Oestradiol 10mcg vaginal pessaries (Vagifem Low) will be inserted by the participant, using an applicator, daily for the first 14 days, then twice weekly for 10 weeks (total treatment duration 12 weeks).The Vagifem Low should be inserted at night (to allow at least 12 hours before serum testing). Adherence to the treatment will be reported by participants in a diary.
Sponsors
University of Sydney
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women with a history of early breast cancer (stage I-III) 2. Aged 18 years or older 3. On an aromatase inhibitor +/- GNRH agonist for at least 3 months 4. Genitourinary symptoms for at least 3 months (moderate or severe for at least one of vaginal dryness, itch, pain, irritation and pain with penetration) 5. Willing and able to comply with all study requirements, including treatment (e.g. able to insert pessaries), questionnaires, blood tests 6. Written informed consent
Exclusion criteria
1. Use of oestrogen, testosterone or progesterone therapies (systemic or vaginal) in the 4 weeks prior to study treatment 2. Active or recent genitourinary infections (<14 days)
Outcome results
None listed