ID

42182

Description

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

Keywords

Versions (2)
  1. 11/11/18 11/11/18 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Copyright Holder

GlaxoSmithKline

Uploaded on

April 13, 2021

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License

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

English

Eligibility Question

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Question
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
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
Description

Gender; Premature Ejaculation

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0033038
The subject must make at least four attempts at sexual intercourse on four separate days during the untreated run in period.
Description

Sex behavior

Data type

boolean

Alias
UMLS CUI [1]
C0036864
The average intravaginal ejaculatory latency time must be < 65 seconds based on the study-provided stop watch assessments.
Description

Ejaculation, Resonse Latency, Time, Intravaginal

Data type

boolean

Alias
UMLS CUI [1,1]
C0013746
UMLS CUI [1,2]
C0242465
UMLS CUI [1,3]
C0040223
UMLS CUI [1,4]
C0013746
UMLS CUI [1,5]
C0442122
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3,1]
C0920548
UMLS CUI [3,2]
C0014441
Previous or Current Medical Conditions
Description

Previous or Current Medical Conditions

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0012634
Erectile dysfunction (defined as IIEF-EF domain score <22)
Description

Erectile Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0242350
Abnormal Lab Values
Description

Abnormal Lab Values

Alias
UMLS CUI-1
C0438215
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.
Description

total serum testosterone measurement

Data type

boolean

Alias
UMLS CUI [1]
C2210797
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.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
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.
Description

Aspartate aminotransferase measurement; Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
Screening PSA value outside the country specific normal reference ranges.
Description

Prostate-Specific Antigen

Data type

boolean

Alias
UMLS CUI [1]
C0138741
TSH outside the country specific normal reference ranges at visit 1.
Description

Thyroid stimulating hormone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202230
Free Triiodothyronine [T3] outside the country specific normal reference ranges at visit 1.
Description

Free Triiodothyronine Assay

Data type

boolean

Alias
UMLS CUI [1]
C0519160
Free Thyroxine T4 outside the country specific normal reference ranges at visit 1.
Description

T4 free measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202225
Other exclusion criteria
Description

Other exclusion criteria

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0205394
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0995150
UMLS CUI [1,2]
C0009830
UMLS CUI [2,1]
C0452456
UMLS CUI [2,2]
C0009830
UMLS CUI [3,1]
C0600183
UMLS CUI [3,2]
C0009830
UMLS CUI [3,3]
C0452453
UMLS CUI [3,4]
C0009830
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Similar models

Eligibility Question

1 forms
  1. StudyEvent: ODM
    1. Eligibility Question
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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