ID

32666

Beschrijving

Study ID: 109059 Clinical Study ID: OTB109059 Study Title: TXA107979:A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men with Premature Ejaculation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01021553 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: epelsiban Trade Name: Study Indication: Premature Ejaculation

Trefwoorden

Versies (2)
  1. 11-11-18 11-11-18 -
  2. 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
Houder van rechten

GlaxoSmithKline

Geüploaded op

11 november 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059

Engels

Eligibility Question

1 Formulieren  
  1. StudyEvent: ODM
    1. Eligibility Question
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693 (Inclusion)
Males with primary PE, according to the ISSM Consensus Definition. Defined as, a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and, inability to delay ejaculation on all or nearly all vaginal penetrations; and, negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy
Beschrijving

Gender; Premature Ejaculation

Datatype

boolean

Alias
UMLS CUI [1]
C0079399 (Gender)
SNOMED
263495000
LOINC
LP61312-2
UMLS CUI [2]
C0033038 (Premature Ejaculation)
SNOMED
44001008
The subject must make at least four attempts at sexual intercourse on four separate days during the untreated run in period.
Beschrijving

Sex behavior

Datatype

boolean

Alias
UMLS CUI [1]
C0036864 (Sex Behavior)
SNOMED
473013003
The average intravaginal ejaculatory latency time must be < 65 seconds based on the study-provided stop watch assessments.
Beschrijving

Ejaculation, Resonse Latency, Time, Intravaginal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013746 (Ejaculation)
SNOMED
40335009
UMLS CUI [1,2]
C0242465 (Response Latency)
UMLS CUI [1,3]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
UMLS CUI [1,4]
C0013746 (Ejaculation)
SNOMED
40335009
UMLS CUI [1,5]
C0442122 (Intravaginal)
SNOMED
264049007
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI-1
C0680251 (Exclusion Criteria)
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result and positive HIV antibody and or confirmatory ELISA test at screening.
Beschrijving

Hepatitis B surface antigen positive; Hepatitis C antibody positive; HIV antibody positive, Enzyme-Linked Immunosorbent Assay

Datatype

boolean

Alias
UMLS CUI [1]
C0149709 (Hepatitis B surface antigen positive)
SNOMED
165806002
UMLS CUI [2]
C0281863 (Hepatitis C antibody positive)
UMLS CUI [3,1]
C0920548 (HIV antibody positive)
UMLS CUI [3,2]
C0014441 (Enzyme-Linked Immunosorbent Assay)
SNOMED
76978006
Previous or Current Medical Conditions
Beschrijving

Previous or Current Medical Conditions

Alias
UMLS CUI-1
C0262926 (Medical History)
SNOMED
392521001
LOINC
LP6817-3
UMLS CUI-2
C0012634 (Disease)
SNOMED
64572001
LOINC
LP21006-9
Erectile dysfunction (defined as IIEF-EF domain score <22)
Beschrijving

Erectile Dysfunction

Datatype

boolean

Alias
UMLS CUI [1]
C0242350 (Erectile dysfunction)
SNOMED
860914002
Abnormal Lab Values
Beschrijving

Abnormal Lab Values

Alias
UMLS CUI-1
C0438215 (Laboratory test result abnormal)
SNOMED
165346000
Subjects who have a serum total testosterone level >25% below the lower limit of normal according to the range of the testing laboratory, when obtained in the morning versus in the afternoon, from screening lab which will need to be evaluated prior to randomization, if an afternoon lab is drawn and the subject meets exclusion criteria a repeat of an am lab is permitted to assess for inclusion in the trial.
Beschrijving

total serum testosterone measurement

Datatype

boolean

Alias
UMLS CUI [1]
C2210797 (total serum testosterone measurement)
Subjects with a clinically significant elevation of serum creatinine outside the country specific normal reference ranges when obtained from a screening lab which will need to be evaluated prior to randomization.
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976 (Creatinine measurement, serum (procedure))
SNOMED
113075003
Subject with a clinically significant elevation of AST of > 126 and/or ALT of > 144 when obtained from a screening lab which will need to be evaluated prior to randomization.
Beschrijving

Aspartate aminotransferase measurement; Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899 (Aspartate aminotransferase measurement)
SNOMED
45896001
UMLS CUI [2]
C0201836 (Alanine aminotransferase measurement)
SNOMED
34608000
Screening PSA value outside the country specific normal reference ranges.
Beschrijving

Prostate-Specific Antigen

Datatype

boolean

Alias
UMLS CUI [1]
C0138741 (Prostate-Specific Antigen)
SNOMED
102687007
LOINC
LP18193-0
TSH outside the country specific normal reference ranges at visit 1.
Beschrijving

Thyroid stimulating hormone measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202230 (Thyroid stimulating hormone measurement)
SNOMED
61167004
Free Triiodothyronine [T3] outside the country specific normal reference ranges at visit 1.
Beschrijving

Free Triiodothyronine Assay

Datatype

boolean

Alias
UMLS CUI [1]
C0519160 (Free Triiodothyronine Assay)
SNOMED
104994008
Free Thyroxine T4 outside the country specific normal reference ranges at visit 1.
Beschrijving

T4 free measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202225 (T4 free measurement)
SNOMED
5113004
LOINC
LP96510-0
Other exclusion criteria
Beschrijving

Other exclusion criteria

Alias
UMLS CUI-1
C0680251 (Exclusion Criteria)
UMLS CUI-2
C0205394 (Other)
SNOMED
74964007
LOINC
LP21049-9
Consumption of seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication, and for the duration of the study.
Beschrijving

Grapefruit (food), Consumption of goods; Grapefruit juice, Consumption of goods; Fruit, Citrus, Consumption of goods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0995150 (Grapefruit (food))
SNOMED
256315005
UMLS CUI [1,2]
C0009830 (Consumption of goods)
UMLS CUI [2,1]
C0452456 (grapefruit juice)
SNOMED
226493000
UMLS CUI [2,2]
C0009830 (Consumption of goods)
UMLS CUI [3,1]
C0600183 (Fruit, Citrus)
SNOMED
102259006
UMLS CUI [3,2]
C0009830 (Consumption of goods)
UMLS CUI [3,3]
|C0452453 (undefined)
UMLS CUI [3,4]
C0009830 (Consumption of goods)
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Similar models

Eligibility Question

1 Formulieren
  1. StudyEvent: ODM
    1. Eligibility Question
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Gender; Premature Ejaculation
Item
Males with primary PE, according to the ISSM Consensus Definition. Defined as, a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and, inability to delay ejaculation on all or nearly all vaginal penetrations; and, negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy
boolean
C0079399 (UMLS CUI [1])
C0033038 (UMLS CUI [2])
Sex behavior
Item
The subject must make at least four attempts at sexual intercourse on four separate days during the untreated run in period.
boolean
C0036864 (UMLS CUI [1])
Ejaculation, Resonse Latency, Time, Intravaginal
Item
The average intravaginal ejaculatory latency time must be < 65 seconds based on the study-provided stop watch assessments.
boolean
C0013746 (UMLS CUI [1,1])
C0242465 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0013746 (UMLS CUI [1,4])
C0442122 (UMLS CUI [1,5])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Hepatitis B surface antigen positive; Hepatitis C antibody positive; HIV antibody positive, Enzyme-Linked Immunosorbent Assay
Item
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result and positive HIV antibody and or confirmatory ELISA test at screening.
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3,1])
C0014441 (UMLS CUI [3,2])
Item Group
Previous or Current Medical Conditions
C0262926 (UMLS CUI-1)
C0012634 (UMLS CUI-2)
Erectile Dysfunction
Item
Erectile dysfunction (defined as IIEF-EF domain score <22)
boolean
C0242350 (UMLS CUI [1])
Item Group
Abnormal Lab Values
C0438215 (UMLS CUI-1)
total serum testosterone measurement
Item
Subjects who have a serum total testosterone level >25% below the lower limit of normal according to the range of the testing laboratory, when obtained in the morning versus in the afternoon, from screening lab which will need to be evaluated prior to randomization, if an afternoon lab is drawn and the subject meets exclusion criteria a repeat of an am lab is permitted to assess for inclusion in the trial.
boolean
C2210797 (UMLS CUI [1])
Creatinine measurement, serum
Item
Subjects with a clinically significant elevation of serum creatinine outside the country specific normal reference ranges when obtained from a screening lab which will need to be evaluated prior to randomization.
boolean
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement; Alanine aminotransferase measurement
Item
Subject with a clinically significant elevation of AST of > 126 and/or ALT of > 144 when obtained from a screening lab which will need to be evaluated prior to randomization.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Prostate-Specific Antigen
Item
Screening PSA value outside the country specific normal reference ranges.
boolean
C0138741 (UMLS CUI [1])
Thyroid stimulating hormone measurement
Item
TSH outside the country specific normal reference ranges at visit 1.
boolean
C0202230 (UMLS CUI [1])
Free Triiodothyronine Assay
Item
Free Triiodothyronine [T3] outside the country specific normal reference ranges at visit 1.
boolean
C0519160 (UMLS CUI [1])
T4 free measurement
Item
Free Thyroxine T4 outside the country specific normal reference ranges at visit 1.
boolean
C0202225 (UMLS CUI [1])
Item Group
Other exclusion criteria
C0680251 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Grapefruit (food), Consumption of goods; Grapefruit juice, Consumption of goods; Fruit, Citrus, Consumption of goods
Item
Consumption of seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication, and for the duration of the study.
boolean
C0995150 (UMLS CUI [1,1])
C0009830 (UMLS CUI [1,2])
C0452456 (UMLS CUI [2,1])
C0009830 (UMLS CUI [2,2])
C0600183 (UMLS CUI [3,1])
C0009830 (UMLS CUI [3,2])
|C0452453 (UMLS CUI [3,3])
C0009830 (UMLS CUI [3,4])
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