It can lead to scratching and rubbing which can break the skin and can lead to soreness, bleeding and skin infections. Vulval itching can affect any woman, at any age. About 1 woman in 10 sees a doctor about a persistently itchy vulva at some stage in her life. The itch may be particularly bad at night and may disturb your sleep. However, pruritus vulvae means the itch is persistent and causes distress. Most women experience a slight vulval itch now and again. The vulva consists of the external female sex organs, including the labia, clitoris, Bartholin's glands and the area of skin just outside the vagina.
Change in Vaginal Dryness Symptom Scores by Current Endocrine Therapy Characteristics Īssociation of response in symptoms with characteristics of the subject population (Dryness and current endocrine therapy)'Pruritus vulvae' simply means itching of the vulva.Change in Vaginal Itching Symptom Scores by Menopause Status Characteristics Īssociation of response in symptoms with characteristics of the subject population (Itching and Menopause status).Change in Dyspareunia Symptom Scores by Menopause Status Characteristics Īssociation of response in symptoms with characteristics of the subject population (Dyspareunia and Menopause status).Change in Vaginal Dryness Symptom Scores by Menopause Status Characteristics Īssociation of response in symptoms with characteristics of the subject population (Dryness and Menopause status).Change in Vaginal Itching Symptom Scores by Age Characteristics Īssociation of response in symptoms with characteristics of the subject population (Itching and Age).
Change in Dyspareunia Symptom Scores by Age Characteristics Īssociation of response in symptoms with characteristics of the subject population (Dyspareunia and Age).median difference) can range from -4 to +4 negative values indicate improved symptoms, zero no change, and positive values indicate worsened symptoms. Change in symptom scores of vaginal dryness, itching, and dyspareunia will be evaluated by the Mayo/North Central Cancer Treatment Group (NCCTG) patient questionnaire which has patients grade how much vaginal dryness, vaginal itching, and vaginal discomfort during intercourse they are currently experiencing on an ordinal scale of zero to four (none, mild, moderate, severe, and very severe, respectively).The median change (i.e. Response in symptoms is calculated as change in symptom score from baseline to week 4 (end of study). Patients apply topical fluocinonide cream twice daily (BID) in weeks 1-2 and once daily (QD) in weeks 3-4.Īssociation of response in symptoms with characteristics of the subject population (Dryness and Age)ĭetermine if there is an association between response in symptoms of vaginal dryness, itching, and/or dyspareunia with characteristics of the subject population. To explore the correlations between patient characteristics and response rates with the use of fluocinonide 0.05% cream. To explore correlation between subject reported compliance, as well as compliance via measurement of the amount of fluocinonide 0.05% cream used, and response rates with the use of fluocinonide 0.05% cream. To explore toxicities reported by subjects using fluocinonide 0.05% cream via vaginal application. Estimates of decrease will be obtained utilizing patient survey instruments.
To estimate the decrease in symptoms of vaginal itching and the total vaginal index score with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. To estimate the decrease in symptoms of vaginal dryness and dyspareunia with the use of fluocinonide 0.05% cream in breast cancer subjects and subjects at increased risk for breast cancer on endocrine therapy. Why Should I Register and Submit Results?.