ID

20759

Descripción

Influence on the Effect of an Oral Contraceptive Drug After Administration of Liraglutide in Postmenopausal Women; ODM derived from: https://clinicaltrials.gov/show/NCT01508858

Link

https://clinicaltrials.gov/show/NCT01508858

Palabras clave

Versiones (1)
  1. 15/3/17 15/3/17 -
Subido en

15 de marzo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes NCT01508858

Inglés

Eligibility Diabetes NCT01508858

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01508858
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal woman
Descripción

Postmenopausal state

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
body mass index (bmi) between 18.0-30.0 kg/m^2 (both inclusive)
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
good general health as judged by the investigator, based on medical history, physical examination including 12-lead ecg (electrocardiogram), vital signs, blood and urinary laboratory assessments
Descripción

General health good | Medical History | Physical Examination | 12 lead ECG | Electrocardiography | Vital signs | Blood specimen for laboratory procedure | Urinalysis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1277245
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0430456
UMLS CUI [5]
C1623258
UMLS CUI [6]
C0518766
UMLS CUI [7]
C0005834
UMLS CUI [8]
C0042014
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator
Descripción

Kidney Disease | Liver disease | Cardiovascular Disease | Lung disease | Gastrointestinal Disease | Metabolic Disease | Endocrine System Disease | Hematological Disease | nervous system disorder | Mental disorder | Disease Major Interferes with Study Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0024115
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0025517
UMLS CUI [7]
C0014130
UMLS CUI [8]
C0018939
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0004936
UMLS CUI [11,1]
C0012634
UMLS CUI [11,2]
C0205164
UMLS CUI [11,3]
C0521102
UMLS CUI [11,4]
C2348563
impaired renal function
Descripción

Renal Insufficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1565489
active hepatitis b and/or active hepatitis c
Descripción

Hepatitis B | Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
positive hiv (human immunodeficiency virus) antibodies
Descripción

HIV antibody positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0920548
known or suspected allergy to trial products or related products
Descripción

Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Suspected Pharmaceutical Preparations Related

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0750491
UMLS CUI [3,3]
C0013230
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0750491
UMLS CUI [4,3]
C0013227
UMLS CUI [4,4]
C0439849
pregnant or positive pregnancy test at screening or nursing mother
Descripción

Pregnancy | Pregnancy test positive | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0240802
UMLS CUI [3]
C0006147
use of prescription or non-prescription medication within 2 weeks prior to first dosing with trial products which in the investigators opinion will interfere with the pharmacokinetics of the compounds in neovletta®
Descripción

Pharmaceutical Preparation Interferes with Ovranette Drug Kinetics | Non-Prescription Drug Interferes with Ovranette Drug Kinetics

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0591930
UMLS CUI [1,4]
C0031327
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0591930
UMLS CUI [2,4]
C0031327
use of hormone replacement therapy within 4 weeks prior to starting dosing with trial product
Descripción

Hormone replacement therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0282402
history of alcoholism or drug abuse
Descripción

Alcoholic Intoxication, Chronic | Drug abuse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0013146
smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
Descripción

Tobacco use Number of cigarettes per day | Tobacco Equivalent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
UMLS CUI [2,1]
C0040329
UMLS CUI [2,2]
C0205163
habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
Descripción

Consumption Excessive Beverages methylxanthine | Consumption Excessive Food methylxanthine | Consumption Excessive Coffee | Consumption Excessive Tea | Consumption Excessive Soft Drinks | Consumption Excessive Cola drink | Consumption Excessive Hot chocolate drink

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C0442802
UMLS CUI [1,3]
C0005329
UMLS CUI [1,4]
C0066447
UMLS CUI [2,1]
C0009830
UMLS CUI [2,2]
C0442802
UMLS CUI [2,3]
C0016452
UMLS CUI [2,4]
C0066447
UMLS CUI [3,1]
C0009830
UMLS CUI [3,2]
C0442802
UMLS CUI [3,3]
C0009237
UMLS CUI [4,1]
C0009830
UMLS CUI [4,2]
C0442802
UMLS CUI [4,3]
C0039400
UMLS CUI [5,1]
C0009830
UMLS CUI [5,2]
C0442802
UMLS CUI [5,3]
C3489624
UMLS CUI [6,1]
C0009830
UMLS CUI [6,2]
C0442802
UMLS CUI [6,3]
C0452444
UMLS CUI [7,1]
C0009830
UMLS CUI [7,2]
C0442802
UMLS CUI [7,3]
C0452243
excessive consumption of a diet deviating from a normal diet as judged by the investigator
Descripción

Consumption Excessive Diet | Normal diet Different

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C0442802
UMLS CUI [1,3]
C0012155
UMLS CUI [2,1]
C0184625
UMLS CUI [2,2]
C1705242
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Similar models

Eligibility Diabetes NCT01508858

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01508858
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Postmenopausal state
Item
postmenopausal woman
boolean
C0232970 (UMLS CUI [1])
Body mass index
Item
body mass index (bmi) between 18.0-30.0 kg/m^2 (both inclusive)
boolean
C1305855 (UMLS CUI [1])
General health good | Medical History | Physical Examination | 12 lead ECG | Electrocardiography | Vital signs | Blood specimen for laboratory procedure | Urinalysis
Item
good general health as judged by the investigator, based on medical history, physical examination including 12-lead ecg (electrocardiogram), vital signs, blood and urinary laboratory assessments
boolean
C1277245 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0430456 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
C0518766 (UMLS CUI [6])
C0005834 (UMLS CUI [7])
C0042014 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Kidney Disease | Liver disease | Cardiovascular Disease | Lung disease | Gastrointestinal Disease | Metabolic Disease | Endocrine System Disease | Hematological Disease | nervous system disorder | Mental disorder | Disease Major Interferes with Study Protocol
Item
history of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the investigator
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0024115 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0025517 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0018939 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0004936 (UMLS CUI [10])
C0012634 (UMLS CUI [11,1])
C0205164 (UMLS CUI [11,2])
C0521102 (UMLS CUI [11,3])
C2348563 (UMLS CUI [11,4])
Renal Insufficiency
Item
impaired renal function
boolean
C1565489 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
active hepatitis b and/or active hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV antibody positive
Item
positive hiv (human immunodeficiency virus) antibodies
boolean
C0920548 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Related | Hypersensitivity Suspected Investigational New Drugs | Hypersensitivity Suspected Pharmaceutical Preparations Related
Item
known or suspected allergy to trial products or related products
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
Pregnancy | Pregnancy test positive | Breast Feeding
Item
pregnant or positive pregnancy test at screening or nursing mother
boolean
C0032961 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Pharmaceutical Preparation Interferes with Ovranette Drug Kinetics | Non-Prescription Drug Interferes with Ovranette Drug Kinetics
Item
use of prescription or non-prescription medication within 2 weeks prior to first dosing with trial products which in the investigators opinion will interfere with the pharmacokinetics of the compounds in neovletta®
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0591930 (UMLS CUI [1,3])
C0031327 (UMLS CUI [1,4])
C0013231 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0591930 (UMLS CUI [2,3])
C0031327 (UMLS CUI [2,4])
Hormone replacement therapy
Item
use of hormone replacement therapy within 4 weeks prior to starting dosing with trial product
boolean
C0282402 (UMLS CUI [1])
Alcoholic Intoxication, Chronic | Drug abuse
Item
history of alcoholism or drug abuse
boolean
C0001973 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Tobacco use Number of cigarettes per day | Tobacco Equivalent
Item
smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
C0040329 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
Consumption Excessive Beverages methylxanthine | Consumption Excessive Food methylxanthine | Consumption Excessive Coffee | Consumption Excessive Tea | Consumption Excessive Soft Drinks | Consumption Excessive Cola drink | Consumption Excessive Hot chocolate drink
Item
habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
boolean
C0009830 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0005329 (UMLS CUI [1,3])
C0066447 (UMLS CUI [1,4])
C0009830 (UMLS CUI [2,1])
C0442802 (UMLS CUI [2,2])
C0016452 (UMLS CUI [2,3])
C0066447 (UMLS CUI [2,4])
C0009830 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
C0009237 (UMLS CUI [3,3])
C0009830 (UMLS CUI [4,1])
C0442802 (UMLS CUI [4,2])
C0039400 (UMLS CUI [4,3])
C0009830 (UMLS CUI [5,1])
C0442802 (UMLS CUI [5,2])
C3489624 (UMLS CUI [5,3])
C0009830 (UMLS CUI [6,1])
C0442802 (UMLS CUI [6,2])
C0452444 (UMLS CUI [6,3])
C0009830 (UMLS CUI [7,1])
C0442802 (UMLS CUI [7,2])
C0452243 (UMLS CUI [7,3])
Consumption Excessive Diet | Normal diet Different
Item
excessive consumption of a diet deviating from a normal diet as judged by the investigator
boolean
C0009830 (UMLS CUI [1,1])
C0442802 (UMLS CUI [1,2])
C0012155 (UMLS CUI [1,3])
C0184625 (UMLS CUI [2,1])
C1705242 (UMLS CUI [2,2])
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