None listed
Conditions
Brief summary
This study will determine the effectiveness of intravaginal testosterone cream therapy for the treatment of sexual dysfunction due to Genitourinary Syndrome of Menopause (GSM) in women with breast cancer being treated with an aromatase inhibitor (AI). Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with invasive breast cancer, currently being treated with an AI and experiencing at least one symptom of vaginal dryness, itch, or pain with sexual activity for which you are seeking treatment Study details -participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will apply the intravaginal testosterone cream, whilst participants in the other group will apply the intravaginal placebo cream. Both groups will apply the creams nightly for the first two weeks and then nightly 3 times a week for the remaining 24 weeks. Circulating levels of hormones will be checked before, during and at the end of the treatment period and participants will be asked to answer questionnaires related to sexual function.
Interventions
300mcg intravaginal testosterone cream will be compounded in the Professional Compounding Centers of America brand Versabase Cream as the base. Application dosing is nightly for 2 weeks then nightly three times a week for 24 weeks. Compliance to treatment will be the use of at least 75% of the medication in each 13 week period ( assessed by weight)
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Women: 1. Who are aged over 18 years with invasive breast cancer treated with an AI 2. Who are experiencing at least one symptom of vaginal dryness, itch causing pain with sexual activity for which they seek treatment. 3. Have less than 5% superficial cells on vaginal smear 4. Have a vaginal pH above 5 5. Have a clinically acceptable Papanicolaou smear (no evidence of malignancy or squamous intraepithelial lesions) within the past 2 years if the cervix is present 6. Have a clinically acceptable mammogram if 50 years or older as per the management of their breast specialist (oncologist or surgeon). 7. who are able and willing to participate in the study as evidenced by providing written consent
Exclusion criteria
Women who have: a) undiagnosed genital bleeding b) used vaginal hormonal products (rings, creams, or gels) in the past month c) sexual dysfunction caused by another medical condition d) used systemic sex steroid therapy (estrogen, testosterone, tibolone or dehydroepiandrosterone) in the preceding 6 months. e) renal disease, history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina at any time before study entry or thrombo-phlebitis within the last 5 years, or any other major illness that has occurred within the last 6 months. f) hypertension equal to or above 160/95 mm Hg g) Significant gastrointestinal, liver or gall bladder disease h) a condition known to affect steroid metabolism or taken therapy known to affect steroid metabolism other than the AI therapy for breast cancer (eg, clomiphene, testolactone, ketoconazole, spironolactone, histamine 2 [Histamine 2 receptor blockers, etc.]) i) a previous diagnosis of cancer, except non melanotic skin cancer j) moderate to severe acne or hirsutism, have used anti-androgen therapy for acne or hirsutism in the preceding 5 years, or who have androgenic alopecia (we will exclude women with clinically meaningful androgen excess) k) have a history of, or current evidence of, abuse of alcohol or any drug substance or be a regular drinker of more than 3 standard drinks per day
Outcome results
None listed