Adult | Gender | Premenopausal state | Postmenopausal state | Breast Carcinoma | Risk Increased Breast Carcinoma | Tamoxifen | Aromatase Inhibitors | Vaginal dryness | Treatment required for Dyspareunia Severe
Item
adult women (both pre-menopausal and post-menopausal women are eligible) and with a history of breast cancer or with an increased risk for breast cancer on current treatment with tamoxifen or an aromatase inhibitor with the presence of vaginal dryness or dyspareunia of sufficient severity to make the subject patient desire therapeutic intervention
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0232969 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
C0678222 (UMLS CUI [5])
C0035647 (UMLS CUI [6,1])
C0205217 (UMLS CUI [6,2])
C0678222 (UMLS CUI [6,3])
C0039286 (UMLS CUI [7])
C0593802 (UMLS CUI [8])
C0241633 (UMLS CUI [9])
C0332121 (UMLS CUI [10,1])
C0013394 (UMLS CUI [10,2])
C0205082 (UMLS CUI [10,3])
Vaginal dryness Disease length | Dyspareunia Disease length
Item
vaginal dryness or dyspareunia must be present for at least two months prior to study entry
boolean
C0241633 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0013394 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Tamoxifen | Aromatase Inhibitors | Treatment Unchanged | Hormone Therapy Dose Unchanged
Item
subjects must be on current treatment with tamoxifen or an aromatase inhibitor for at least two months prior to study enrollment (defined as the date of consent) and should not be planning to discontinue treatment or to change dose or type of endocrine treatment during the duration of the study
boolean
C0039286 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0442739 (UMLS CUI [3,2])
C0279025 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0442739 (UMLS CUI [4,3])
Vaginal preparations Absent | Vaginal lubricants Absent | Vaginal Cream Absent | Vaginal Gel Absent | Vaginal Ointment Absent | Vaginal solution Absent | Fluocinonide Topical Cream
Item
subjects must agree to not use any over-the-counter or prescription vaginal preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of treatment with topical fluocinonide cream
boolean
C2064912 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0356770 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0042238 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0042257 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0991586 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C1273007 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C1252953 (UMLS CUI [7])
Absence Pharmaceutical Preparations Containing Estrogens | Fluocinonide Topical Cream
Item
subjects must agree to not use any medications, products, or preparations known to contain estrogen during the four weeks of treatment with topical fluocinonide cream
boolean
C0332197 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0014939 (UMLS CUI [1,4])
C1252953 (UMLS CUI [2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status =< 2
boolean
C1520224 (UMLS CUI [1])
Able to read Questionnaires | Comprehension Questionnaires | Questionnaires Completion | Able to read Questionnaires Assisted | Comprehension Questionnaires Assisted | Questionnaires Completion Assisted
Item
subjects must have ability to read, comprehend, and complete patient questionnaires independently or with assistance
boolean
C0586740 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0162340 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0034394 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0586740 (UMLS CUI [4,1])
C0034394 (UMLS CUI [4,2])
C1269765 (UMLS CUI [4,3])
C0162340 (UMLS CUI [5,1])
C0034394 (UMLS CUI [5,2])
C1269765 (UMLS CUI [5,3])
C0034394 (UMLS CUI [6,1])
C0205197 (UMLS CUI [6,2])
C1269765 (UMLS CUI [6,3])
Informed Consent
Item
subjects must sign informed consent
boolean
C0021430 (UMLS CUI [1])
Patient instructions Barrier Contraception
Item
subjects must agree to read patient instructions regarding use of barrier contraceptive devices while on treatment with fluocinonide cream in the informed consent
boolean
C2051542 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
Vaginal preparations | Exception Vaginal preparations Discontinued
Item
use of any vaginal preparations within one week prior to study enrollment (exception: subjects currently using a vaginal preparation can enroll after discontinuing treatment for 7 days)
boolean
C2064912 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2064912 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
Pharmaceutical Preparations Containing Estrogens
Item
use of any estrogen containing medications, products, or preparations
boolean
C0013227 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0014939 (UMLS CUI [1,3])
Systemic steroids Oral | Systemic steroids Parenteral | inhaled steroids High dose Daily | Corticosteroid use Intranasal High dose Daily
Item
use of any systemic oral or parenteral steroid containing medications is not permitted; use of "high daily dose" inhaled/intranasal corticosteroids is not permitted; use inhaled/intranasal corticosteroid preparations at dosing levels less than "high daily dose" is permitted
boolean
C2825233 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2,1])
C1518896 (UMLS CUI [2,2])
C2065041 (UMLS CUI [3,1])
C0444956 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
C0239126 (UMLS CUI [4,1])
C0001560 (UMLS CUI [4,2])
C0444956 (UMLS CUI [4,3])
C0332173 (UMLS CUI [4,4])
Fluocinonide Cream Vaginal dryness | Fluocinonide Cream Pruritus of vagina | Fluocinonide Cream Dyspareunia
Item
current or past treatment with fluocinonide cream for vaginal dryness, itching, or dyspareunia
boolean
C1252953 (UMLS CUI [1,1])
C0241633 (UMLS CUI [1,2])
C1252953 (UMLS CUI [2,1])
C0042256 (UMLS CUI [2,2])
C1252953 (UMLS CUI [3,1])
C0013394 (UMLS CUI [3,2])
Symptoms Vaginal infection | Vaginal Discharge | Vaginal odor
Item
subject reported symptoms of vaginal infection with significant vaginal discharge or odor
boolean
C1457887 (UMLS CUI [1,1])
C0404521 (UMLS CUI [1,2])
C0227791 (UMLS CUI [2])
C0235678 (UMLS CUI [3])
Vaginal infection
Item
known current vaginal infection
boolean
C0404521 (UMLS CUI [1])
Vaginal Disease | Exception Atrophy of vagina | Explanation Symptoms Vaginal
Item
known vaginal pathology other than vaginal atrophy that could explain vaginal symptoms
boolean
C0042251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0241616 (UMLS CUI [2,2])
C0681841 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C4317111 (UMLS CUI [3,3])
Intolerance to Topical steroids
Item
known intolerance of topical steroid preparations
boolean
C1744706 (UMLS CUI [1,1])
C2064827 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women (to be obtained via subject report only)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Diabetes Mellitus | Adrenal gland hypofunction | Addison Disease | Cushing Syndrome
Item
known diagnoses of diabetes mellitus, adrenal insufficiency (addison's disease), or cushing's syndrome
boolean
C0011849 (UMLS CUI [1])
C0001623 (UMLS CUI [2])
C0001403 (UMLS CUI [3])
C0010481 (UMLS CUI [4])
Prior Chemotherapy Malignant Neoplasms | Exception Breast Carcinoma
Item
no prior chemotherapeutic treatment for any malignancy other than breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])