ID
35436
Beschrijving
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male
Trefwoorden
Versies (2)
- 30-01-19 30-01-19 -
- 04-03-19 04-03-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
4 maart 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218
Screening Visit - Eligibility Criteria
- StudyEvent: ODM
Beschrijving
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Gender, Health Status
Datatype
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0018759
Beschrijving
Age
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Body weight, Body mass index
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005910
- UMLS CUI [2]
- C1305855
Beschrijving
English Language
Datatype
boolean
Alias
- UMLS CUI [1]
- C0376245
Beschrijving
Informed Consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Comprehension, Protocol Compliance
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0162340
- UMLS CUI [1,2]
- C0525058
Beschrijving
Duasteride, Finasteride
Datatype
boolean
Alias
- UMLS CUI [1]
- C0754659
- UMLS CUI [2]
- C0060389
Beschrijving
Prostate Specific Antigen measurement
Datatype
boolean
Alias
- UMLS CUI [1]
- C0201544
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Medically unfit, Clinical Research
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3841806
- UMLS CUI [1,2]
- C0008972
Beschrijving
Sleep Apnea Syndromes
Datatype
boolean
Alias
- UMLS CUI [1]
- C0037315
Beschrijving
Psychiatric problem
Datatype
boolean
Alias
- UMLS CUI [1]
- C1306597
Beschrijving
Breast Carcinoma, Prostate Carcinoma
Datatype
boolean
Alias
- UMLS CUI [1]
- C0678222
- UMLS CUI [2]
- C0600139
Beschrijving
Hepatitis B surface antigen positive; Hepatitis C antibody positive; HIV antibody positive
Datatype
boolean
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
- UMLS CUI [3]
- C0920548
Beschrijving
Systolic Pressure, Diastolic blood pressure, Heart rate
Datatype
boolean
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C0428883
- UMLS CUI [3]
- C0018810
Beschrijving
12-lead ECG, PR interval; 12-lead ECG, QRS Complex Duration; 12-lead ECG, QTcB
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
- UMLS CUI [2,1]
- C0430456
- UMLS CUI [2,2]
- C0429025
- UMLS CUI [3,1]
- C0430456
- UMLS CUI [3,2]
- C1882512
Beschrijving
Triglyceride level
Datatype
boolean
Alias
- UMLS CUI [1]
- C0202236
Beschrijving
Thyroid function tests abnormal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0476414
Beschrijving
Aspartate aminotransferase measurement, Alanine aminotransferase measurement, Serum conjugated bilirubin measurement, Alkaline phosphatase measurement
Datatype
boolean
Alias
- UMLS CUI [1]
- C0201899
- UMLS CUI [2]
- C0201836
- UMLS CUI [3]
- C1278038
- UMLS CUI [4]
- C0201850
Beschrijving
Hemoglobin measurement
Datatype
boolean
Alias
- UMLS CUI [1]
- C0518015
Beschrijving
Alcohol Abuse
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085762
Beschrijving
Alcohol Abstinence, Unwilling
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0678274
- UMLS CUI [1,2]
- C0558080
Beschrijving
Smoking History, Tobacco use, Nicotine
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1519384
- UMLS CUI [1,2]
- C0543414
- UMLS CUI [2]
- C0028040
Beschrijving
Study Subject Participation Status, Investigational New Drugs
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
Beschrijving
Drug Abstinence, Unwilling, Compliance Behaviour
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0237443
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [2]
- C1321605
Beschrijving
Pharmaceutical Preparations, Dietary Supplements, Herbal Supplements
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013227
- UMLS CUI [2]
- C0242295
- UMLS CUI [3]
- C1504473
Beschrijving
Grapefruit, Grapefruit juice
Datatype
boolean
Alias
- UMLS CUI [1]
- C0995150
- UMLS CUI [2]
- C0452456
Beschrijving
Caffeine, Abstinence, Unwilling; Xanthine, Abstinence, Unwilling
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0006644
- UMLS CUI [1,2]
- C3843422
- UMLS CUI [1,3]
- C0558080
- UMLS CUI [2,1]
- C0043314
- UMLS CUI [2,2]
- C3843422
- UMLS CUI [2,3]
- C0558080
Beschrijving
Urine drug screening, Urine cotinine test, Ethanol measurement
Datatype
boolean
Alias
- UMLS CUI [1]
- C0202274
- UMLS CUI [2]
- C1697737
- UMLS CUI [3]
- C0202304
Beschrijving
Blood Donation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005794
Beschrijving
Experimental drug, Hypersensitivity
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0020517
Beschrijving
Reproductive Hormone, Abnormal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0597376
- UMLS CUI [1,2]
- C0205161
Similar models
Screening Visit - Eligibility Criteria
- StudyEvent: ODM
C0018759 (UMLS CUI [2])
C1305855 (UMLS CUI [2])
C0525058 (UMLS CUI [1,2])
C0060389 (UMLS CUI [2])
C0008972 (UMLS CUI [1,2])
C0600139 (UMLS CUI [2])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3])
C0428883 (UMLS CUI [2])
C0018810 (UMLS CUI [3])
C0429087 (UMLS CUI [1,2])
C0430456 (UMLS CUI [2,1])
C0429025 (UMLS CUI [2,2])
C0430456 (UMLS CUI [3,1])
C1882512 (UMLS CUI [3,2])
C0201836 (UMLS CUI [2])
C1278038 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0558080 (UMLS CUI [1,2])
C0543414 (UMLS CUI [1,2])
C0028040 (UMLS CUI [2])
C0013230 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,2])
C1321605 (UMLS CUI [2])
C0242295 (UMLS CUI [2])
C1504473 (UMLS CUI [3])
C0452456 (UMLS CUI [2])
C3843422 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0043314 (UMLS CUI [2,1])
C3843422 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C1697737 (UMLS CUI [2])
C0202304 (UMLS CUI [3])
C0020517 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])