ID

38316

Beskrivning

Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01422408

Länk

https://clinicaltrials.gov/show/NCT01422408

Nyckelord

Versioner (1)
  1. 2019-10-09 2019-10-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Carcinoma NCT01422408

Engelsk

Eligibility Breast Carcinoma NCT01422408

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Beskrivning

Adult | Gender | Premenopausal state | Postmenopausal state | Breast Carcinoma | Risk Increased Breast Carcinoma | Tamoxifen | Aromatase Inhibitors | Vaginal dryness | Treatment required for Dyspareunia Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0232969
UMLS CUI [4]
C0232970
UMLS CUI [5]
C0678222
UMLS CUI [6,1]
C0035647
UMLS CUI [6,2]
C0205217
UMLS CUI [6,3]
C0678222
UMLS CUI [7]
C0039286
UMLS CUI [8]
C0593802
UMLS CUI [9]
C0241633
UMLS CUI [10,1]
C0332121
UMLS CUI [10,2]
C0013394
UMLS CUI [10,3]
C0205082
vaginal dryness or dyspareunia must be present for at least two months prior to study entry
Beskrivning

Vaginal dryness Disease length | Dyspareunia Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0241633
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0013394
UMLS CUI [2,2]
C0872146
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
Beskrivning

Tamoxifen | Aromatase Inhibitors | Treatment Unchanged | Hormone Therapy Dose Unchanged

Datatyp

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2]
C0593802
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0442739
UMLS CUI [4,1]
C0279025
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0442739
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
Beskrivning

Vaginal preparations Absent | Vaginal lubricants Absent | Vaginal Cream Absent | Vaginal Gel Absent | Vaginal Ointment Absent | Vaginal solution Absent | Fluocinonide Topical Cream

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2064912
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0356770
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0042238
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0042257
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0991586
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C1273007
UMLS CUI [6,2]
C0332197
UMLS CUI [7]
C1252953
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
Beskrivning

Absence Pharmaceutical Preparations Containing Estrogens | Fluocinonide Topical Cream

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0014939
UMLS CUI [2]
C1252953
eastern cooperative oncology group (ecog) performance status =< 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
subjects must have ability to read, comprehend, and complete patient questionnaires independently or with assistance
Beskrivning

Able to read Questionnaires | Comprehension Questionnaires | Questionnaires Completion | Able to read Questionnaires Assisted | Comprehension Questionnaires Assisted | Questionnaires Completion Assisted

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0034394
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0034394
UMLS CUI [3,1]
C0034394
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C0586740
UMLS CUI [4,2]
C0034394
UMLS CUI [4,3]
C1269765
UMLS CUI [5,1]
C0162340
UMLS CUI [5,2]
C0034394
UMLS CUI [5,3]
C1269765
UMLS CUI [6,1]
C0034394
UMLS CUI [6,2]
C0205197
UMLS CUI [6,3]
C1269765
subjects must sign informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
subjects must agree to read patient instructions regarding use of barrier contraceptive devices while on treatment with fluocinonide cream in the informed consent
Beskrivning

Patient instructions Barrier Contraception

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2051542
UMLS CUI [1,2]
C0004764
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
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)
Beskrivning

Vaginal preparations | Exception Vaginal preparations Discontinued

Datatyp

boolean

Alias
UMLS CUI [1]
C2064912
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2064912
UMLS CUI [2,3]
C1444662
use of any estrogen containing medications, products, or preparations
Beskrivning

Pharmaceutical Preparations Containing Estrogens

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0014939
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
Beskrivning

Systemic steroids Oral | Systemic steroids Parenteral | inhaled steroids High dose Daily | Corticosteroid use Intranasal High dose Daily

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C2825233
UMLS CUI [2,2]
C1518896
UMLS CUI [3,1]
C2065041
UMLS CUI [3,2]
C0444956
UMLS CUI [3,3]
C0332173
UMLS CUI [4,1]
C0239126
UMLS CUI [4,2]
C0001560
UMLS CUI [4,3]
C0444956
UMLS CUI [4,4]
C0332173
current or past treatment with fluocinonide cream for vaginal dryness, itching, or dyspareunia
Beskrivning

Fluocinonide Cream Vaginal dryness | Fluocinonide Cream Pruritus of vagina | Fluocinonide Cream Dyspareunia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1252953
UMLS CUI [1,2]
C0241633
UMLS CUI [2,1]
C1252953
UMLS CUI [2,2]
C0042256
UMLS CUI [3,1]
C1252953
UMLS CUI [3,2]
C0013394
subject reported symptoms of vaginal infection with significant vaginal discharge or odor
Beskrivning

Symptoms Vaginal infection | Vaginal Discharge | Vaginal odor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0404521
UMLS CUI [2]
C0227791
UMLS CUI [3]
C0235678
known current vaginal infection
Beskrivning

Vaginal infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0404521
known vaginal pathology other than vaginal atrophy that could explain vaginal symptoms
Beskrivning

Vaginal Disease | Exception Atrophy of vagina | Explanation Symptoms Vaginal

Datatyp

boolean

Alias
UMLS CUI [1]
C0042251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0241616
UMLS CUI [3,1]
C0681841
UMLS CUI [3,2]
C1457887
UMLS CUI [3,3]
C4317111
known intolerance of topical steroid preparations
Beskrivning

Intolerance to Topical steroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C2064827
pregnant or lactating women (to be obtained via subject report only)
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known diagnoses of diabetes mellitus, adrenal insufficiency (addison's disease), or cushing's syndrome
Beskrivning

Diabetes Mellitus | Adrenal gland hypofunction | Addison Disease | Cushing Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0001623
UMLS CUI [3]
C0001403
UMLS CUI [4]
C0010481
no prior chemotherapeutic treatment for any malignancy other than breast cancer
Beskrivning

Prior Chemotherapy Malignant Neoplasms | Exception Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
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Similar models

Eligibility Breast Carcinoma NCT01422408

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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