ID
42154
Description
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
Mots-clés
Versions (5)
- 22/10/2018 22/10/2018 -
- 14/01/2019 14/01/2019 -
- 04/03/2019 04/03/2019 -
- 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
- 17/11/2021 17/11/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
13 avril 2021
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218
Part 2 - Screening Visit - Eligibility Criteria
- StudyEvent: ODM
Description
Eligibility Question
Alias
- UMLS CUI-1
- C0013893
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
Gender, Health Status
Type de données
boolean
Alias
- UMLS CUI [1]
- C0079399
- UMLS CUI [2]
- C0018759
Description
Age
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
Body weight, Body mass index
Type de données
boolean
Alias
- UMLS CUI [1]
- C0005910
- UMLS CUI [2]
- C1305855
Description
English Language
Type de données
boolean
Alias
- UMLS CUI [1]
- C0376245
Description
Informed Consent
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Comprehension, Protocol Compliance
Type de données
boolean
Alias
- UMLS CUI [1]
- C0162340
- UMLS CUI [2]
- C0525058
Description
Duasteride, Finasteride
Type de données
boolean
Alias
- UMLS CUI [1]
- C0754659
- UMLS CUI [2]
- C0060389
Description
Prostate Specific Antigen measurement
Type de données
boolean
Alias
- UMLS CUI [1]
- C0201544
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Medically unfit, Clinical Research
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C3841806
- UMLS CUI [1,2]
- C0008972
Description
Sleep Apnea Syndromes
Type de données
boolean
Alias
- UMLS CUI [1]
- C0037315
Description
Psychiatric problem
Type de données
boolean
Alias
- UMLS CUI [1]
- C1306597
Description
Breast Carcinoma, Prostate Carcinoma
Type de données
boolean
Alias
- UMLS CUI [1]
- C0678222
- UMLS CUI [2]
- C0600139
Description
Hepatitis B surface antigen positive; Hepatitis C antibody positive; HIV antibody positive
Type de données
boolean
Alias
- UMLS CUI [1]
- C0149709
- UMLS CUI [2]
- C0281863
- UMLS CUI [3]
- C0920548
Description
Systolic Pressure, Diastolic blood pressure, Heart rate
Type de données
boolean
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C0428883
- UMLS CUI [3]
- C0018810
Description
12-lead ECG, PR interval; 12-lead ECG, QRS Complex Duration; 12-lead ECG, QTcB
Type de données
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
Description
Triglyceride level
Type de données
boolean
Alias
- UMLS CUI [1]
- C0202236
Description
Thyroid function tests abnormal
Type de données
boolean
Alias
- UMLS CUI [1]
- C0476414
Description
Aspartate aminotransferase measurement, Alanine aminotransferase measurement, Serum conjugated bilirubin measurement, Alkaline phosphatase measurement
Type de données
boolean
Alias
- UMLS CUI [1]
- C0201899
- UMLS CUI [2]
- C0201836
- UMLS CUI [3]
- C1278038
- UMLS CUI [4]
- C0201850
Description
Hemoglobin measurement
Type de données
boolean
Alias
- UMLS CUI [1]
- C0518015
Description
Alcohol Abuse
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085762
Description
Alcohol Abstinence, Unwilling
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0678274
- UMLS CUI [1,2]
- C0558080
Description
Smoking History, Tobacco use; Nicotine
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519384
- UMLS CUI [1,2]
- C0543414
- UMLS CUI [2]
- C0028040
Description
Study Subject Participation Status, Investigational New Drugs
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0013230
Description
Drug Abstinence, Unwilling, Compliance Behaviour
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0237443
- UMLS CUI [1,2]
- C0558080
- UMLS CUI [1,3]
- C1321605
Description
Pharmaceutical Preparations, Dietary Supplements, Herbal Supplements
Type de données
boolean
Alias
- UMLS CUI [1]
- C0013227
- UMLS CUI [2]
- C0242295
- UMLS CUI [3]
- C1504473
Description
Grapefruit, Grapefruit juice
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0995150
- UMLS CUI [1,2]
- | C0452456
Description
Caffeine, Abstinence, Unwilling; Xanthine, Abstinence, Unwilling
Type de données
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
Description
Urine drug screening, Urine cotinine test, Ethanol measurement
Type de données
boolean
Alias
- UMLS CUI [1]
- C0202274
- UMLS CUI [2]
- C1697737
- UMLS CUI [3]
- C0202304
Description
Blood Donation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0005794
Description
Experimental drug, Hypersensitivity
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0020517
Description
Reproductive Hormone, Abnormal
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0597376
- UMLS CUI [1,2]
- C0205161
Similar models
Part 2 - Screening Visit - Eligibility Criteria
- StudyEvent: ODM
C0018759 (UMLS CUI [2])
C1305855 (UMLS CUI [2])
C0525058 (UMLS CUI [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 [1,3])
C0242295 (UMLS CUI [2])
C1504473 (UMLS CUI [3])
| C0452456 (UMLS CUI [1,2])
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])