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])
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])