Sexual Well Being After Breast cancer study - SWAB study
- Conditions
- Vulvovaginal AtrophyBreast cancerRenal and Urogenital - Other renal and urogenital disordersCancer - BreastReproductive Health and Childbirth - Menstruation and menopause
- Registration Number
- ACTRN12615000083594
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 44
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of the efficacy of intravaginal testosterone therapy, for the treatment of sexual dysfunction due to vulvo vaginal atrophy in women who have symptoms estrogen insufficiency having treatment of breast cancer with an aromatase inhibitor (AI) as assessed by the satisfaction domain of the Female Sexual Function Index[26 weeks]
- Secondary Outcome Measures
Name Time Method Assessment of sexual wellbeing as assessed by<br>a)the total score of the Female Sexual Function Index ( FSFI)<br>b)the subdomains of desire, arousal, orgasm, satisfaction and sexual pain <br>c)distress associated with female sexual dysfunction measured by the Female Sexual Distress Scale- revised ( FSDS-R) <br>[26 weeks];Indices of vaginal health as assessed by: a)Atrophic vaginitis assessed by clinical examination b) Change in vaginal pH c)Change in the proportion of vaginal parabasal and superficial cells d)the Profile of Female Sexual Function (PFSP) questionnaire[26 weeks];The presence of urinary incontinence as assessed by the Questionnaire for Urinary Incontinence Diagnosis (QUID)[26 weeks];The circulating levels of Estradiol, Estrone, Testosterone, Dihydrotestosterone and their metabolites by liquid chromatography mass spectrometry (LCMS).[26 weeks]