ID

32542

Beschreibung

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

Stichworte

Versionen (1)
  1. 06.11.18 06.11.18 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

6. November 2018

DOI

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Lizenz

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

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility
Screening Inclusion Criteria
Beschreibung

Screening Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Stable heterosexual relationship, with a single non pregnant, nonlactating female partner using adequate contraception (as confirmed by oral questioning of male study subject) in a relationship of greater than >4 months duration. This same partner will be the one with whom the subject makes and records all IELT attempts during the duration of the study.
Beschreibung

Heterosexual relationship, Stable status; Adequate, Contraceptive methods; no, Pregnancy of partner

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0556476
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0205411
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C1298908
UMLS CUI [3,2]
C0919624
Aged between 18 and 55 years (i.e. subjects must not have completed their 55th year birthday at the time of screening, but can turn 55 years during the course of the study).
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Beschreibung

Liver diseases; Abnormality of the liver; Biliary tract abnormality

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C4021780
UMLS CUI [3]
C0549613
Previous or Current Medical Conditions
Beschreibung

Previous or Current Medical Conditions

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C3899485
Active or recent (< 6 months) history of prostatitis, as determined by patient symptoms or treatment seeking for newly diagnosed or flare of symptoms related to previously diagnosed prostatitis.
Beschreibung

Prostatitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0033581
Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
Beschreibung

Disease; Mental disorders; Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C0004936
UMLS CUI [3]
C0038586
Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s disease or prior surgery for Peyronies disease) that in the opinion of the investigator would significantly impair sexual performance.
Beschreibung

Penis, Abnormality, Antatomic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030851
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0220784
Prior implantation of penile implant for erectile dysfunction.
Beschreibung

Penis, Implant, Erectile Dysfunction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030851
UMLS CUI [1,2]
C0021102
UMLS CUI [1,3]
C0242350
Primary hypoactive sexual desire.
Beschreibung

Hypoactive Sexual Desire Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0020594
Spinal cord injury.
Beschreibung

Spinal Cord Injuries

Datentyp

boolean

Alias
UMLS CUI [1]
C0037929
History of seizures, within last 6 months.
Beschreibung

Seizures

Datentyp

boolean

Alias
UMLS CUI [1]
C0036572
History of prostate cancer treated or untreated.
Beschreibung

Prostate carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0600139
History of prostatectomy or prostate procedures for any cause.
Beschreibung

Prostatectomy; Prostate, Procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0033573
UMLS CUI [2,1]
C0033572
UMLS CUI [2,2]
C2700391
Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia.
Beschreibung

hematological disease, chronic disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C0008679
Significant active peptic ulceration.
Beschreibung

Peptic Ulcer, Active disease diagnosis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030920
UMLS CUI [1,2]
C2707252
Presence of the following conditions prior to screening: myocardial infarction, coronary bypass surgery, coronary artery angioplasty, unstable angina, clinically evident congestive heart failure, cardiac pacemaker, or cerebrovascular accident.
Beschreibung

Myocardial Infarction; Coronary Artery Bypass Surgery; Angioplasty, Balloon, Coronary; Angina, Unstable; Congestive heart failure; Artificial cardiac pacemaker; Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0010055
UMLS CUI [3]
C0002997
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0030163
UMLS CUI [7]
C0038454
Cardiac arrhythmia: significant cardiac arrhythmia shown on screening ECG, or a known or suspected history of significant cardiac arrhythmias within six months prior to screening. i.e., pre- existing syndromes, sinus pause > 3 seconds, non-sustained ventricular tachycardia (3 consecutive ectopic beats), sustained ventricular tachycardia (30 consecutive ectopic beats), sustained supraventricular tachycardia (30 consecutive ectopic beats), accessory pathway tachycardia, bradycardia (heart rate < 45 beats per minute), atrial flutter, atrial fibrillation, ectopic pacemaker, sick sinus syndrome, ventricular block (second or third degree), or left bundle branch block patients with right bundle branch block with no other symptoms of vascular history and no other medical concerns as determined by the PI and the GSK monitor are permitted entry into the trial, consultation with the GSK medical monitor prior to entry is required. Uncontrolled atrial fibrillation/flutter (ventricular response rate ≥100 bpm) at the screening visit (Visit 1).
Beschreibung

Cardiac Arrhythmia

Datentyp

boolean

Alias
UMLS CUI [1]
C0003811
History of congenital QT prolongation and/or QTc interval >450msec at screening visit (Visit 1) using the Bazett formula
Beschreibung

Prolonged QT interval, Congenital qualifier; Electrocardiogram QT corrected interval prolonged

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151878
UMLS CUI [1,2]
C1744681
UMLS CUI [2]
C0855333
Systolic cuff BP > 150 mmHg in the seated position at screening visit (Visit1), if the initial supine measure is >150mmHg, repeat the measure in sequence times 3 within 5-10 minutes of the last measure and take the mean of the three measures, if the average is >150mmHg then the subject may not enter the trial.
Beschreibung

Systolic Pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0871470
Diastolic cuff BP >95 mmHg in the seated position at screening visit (Visit 1), if the initial supine measure is >95mmHg, repeat the measure in sequence 3 times within 5-10 minutes of the last measure and take the average of the three measures, if the average is >95mmHg then the subject may not enter the trial.
Beschreibung

Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C042883
History of malignancy within the past five years (other than squamous or basal cell skin cancer).
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
Any condition which would preclude sexual activity.
Beschreibung

Condition, interferes with, Sex Behavior

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0036864
Concomitant Medications
Beschreibung

Concomitant Medications

Alias
UMLS CUI-1
C2347852
No concomitant medications know to impact IELT may be used within 7 days or 5 half lives (whichever is longer) of recording first IELT or at any time during the study this includes; SSRI’s, phosphodiesterase type 5 inhibitors, topical anesthetics muopioid antagonists, vacuum devices, constrictive devices, penile injections, urethral suppositories, gels, any over-the-counter herbal or non- prescription medications, and products purchased via the internet or mail order pharmacies, all other medications may be stopped at Visit 1 unless a period of tapering prior to discontinuation is required. During the course of the study the only cconcomitant medication use which can be considered includes inhaled or intra nasal agents for asthmatic patients and patients with allergic rhinitis, who are on stable doses of inhaled or intra nasal agents as prescribed by their health care providers, and who have had no adjustments in their prescribed and or actual use within the last 60 days. Agents which are known or expected to have significant systemic exposures as a result of inhaled or intra-nasal use or to have known CYP3A4 drug-drug interaction potential are not included in this exemption.
Beschreibung

Concomitant Agent

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Subjects who have received any investigational drug (including placebo) within 30 days of the screening visit or 5 half lives of the investigational drug whichever is longer (Visit 1).
Beschreibung

Study Subject Participation Status, Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
Other Exclusion Criteria
Beschreibung

Other Exclusion Criteria

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0205394
Severe chronic or acute liver disease, history of moderate (Child- Pugh B) or severe (Child-Pugh C) hepatic impairment.
Beschreibung

Liver Diseases; Hepatic Impairment

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0948807
Subjects with known hypersensitivity to GSK557296 or any component of the investigational medication.
Beschreibung

GSK557296, Hypersensitivity; Investigational New Drugs, Hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3886683
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0020517
Subjects who are illiterate or unable to understand the questionnaires or the subject diary.
Beschreibung

Illiteracy; Comprehension, Unable

Datentyp

boolean

Alias
UMLS CUI [1]
C0020899
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C1299582
Subjects who are unwilling or unable to complete the subject diary.
Beschreibung

Subject Diary, Complete, Unwilling; Subject Diary, Complete, Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0034656
UMLS CUI [2,1]
C3890583
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C1299582
Subjects who are unwilling to be randomized to placebo.
Beschreibung

Randomization; Uniwlling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0034656
Subject whose sexual partner is actively trying to conceive, and or is unwilling to use a reliable form of birth control as outlined in Section 8.1 for the duration of the trial. Or whose female partner is breast feeding. If the male partner has been using condoms with their monogamous partner for a minimum of 4 months prior to consideration of enrollment in the trial and they will continue to use the same type of condoms for the duration of the trial without exception and for all IELT measures during screening and active treatment. Then they may be considered for entry into the trial. Condoms with topical anesthetic creams are not permitted and use of these will be considered an exclusion from participation in the trial. Condom use should be noted in the electron CRF.
Beschreibung

Partner in relationship, Pregnancy, Planned; Partner in relationship, Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0682323
UMLS CUI [1,2]
C0032992
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0006147
Subjects, who in the opinion of the investigator, would be non- compliant with the majority of the visits scheduled or study procedures.
Beschreibung

Non-Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0457432
History of sensitivity to heparin or heparin-induced thrombocytopenia (for subjects at sites where PK studies are planned).
Beschreibung

heparin, Hypersensitivity; Heparin-induced thrombocytopenia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0020517
UMLS CUI [2]
C0272285
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 1 month prior to screening.
Beschreibung

Cotinine measurement; Tobacco Use

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0202363
UMLS CUI [1,2]
C0543414
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Screening Inclusion Criteria
C1512693 (UMLS CUI-1)
Heterosexual relationship, Stable status; Adequate, Contraceptive methods; no, Pregnancy of partner
Item
Stable heterosexual relationship, with a single non pregnant, nonlactating female partner using adequate contraception (as confirmed by oral questioning of male study subject) in a relationship of greater than >4 months duration. This same partner will be the one with whom the subject makes and records all IELT attempts during the duration of the study.
boolean
C0556476 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0205411 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1298908 (UMLS CUI [3,1])
C0919624 (UMLS CUI [3,2])
Age
Item
Aged between 18 and 55 years (i.e. subjects must not have completed their 55th year birthday at the time of screening, but can turn 55 years during the course of the study).
boolean
C0001779 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Liver diseases; Abnormality of the liver; Biliary tract abnormality
Item
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
boolean
C0023895 (UMLS CUI [1])
C4021780 (UMLS CUI [2])
C0549613 (UMLS CUI [3])
Item Group
Previous or Current Medical Conditions
C0262926 (UMLS CUI-1)
C3899485 (UMLS CUI-2)
Prostatitis
Item
Active or recent (< 6 months) history of prostatitis, as determined by patient symptoms or treatment seeking for newly diagnosed or flare of symptoms related to previously diagnosed prostatitis.
boolean
C0033581 (UMLS CUI [1])
Disease; Mental disorders; Substance Use Disorders
Item
Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
boolean
C0012634 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
C0038586 (UMLS CUI [3])
Penis, Abnormality, Antatomic
Item
Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s disease or prior surgery for Peyronies disease) that in the opinion of the investigator would significantly impair sexual performance.
boolean
C0030851 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0220784 (UMLS CUI [1,3])
Penis, Implant, Erectile Dysfunction
Item
Prior implantation of penile implant for erectile dysfunction.
boolean
C0030851 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C0242350 (UMLS CUI [1,3])
Hypoactive Sexual Desire Disorder
Item
Primary hypoactive sexual desire.
boolean
C0020594 (UMLS CUI [1])
Spinal Cord Injuries
Item
Spinal cord injury.
boolean
C0037929 (UMLS CUI [1])
Seizures
Item
History of seizures, within last 6 months.
boolean
C0036572 (UMLS CUI [1])
Prostate carcinoma
Item
History of prostate cancer treated or untreated.
boolean
C0600139 (UMLS CUI [1])
Prostatectomy; Prostate, Procedure
Item
History of prostatectomy or prostate procedures for any cause.
boolean
C0033573 (UMLS CUI [1])
C0033572 (UMLS CUI [2,1])
C2700391 (UMLS CUI [2,2])
hematological disease, chronic disease
Item
Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia.
boolean
C0018939 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
Peptic Ulcer, Active disease diagnosis
Item
Significant active peptic ulceration.
boolean
C0030920 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
Myocardial Infarction; Coronary Artery Bypass Surgery; Angioplasty, Balloon, Coronary; Angina, Unstable; Congestive heart failure; Artificial cardiac pacemaker; Cerebrovascular accident
Item
Presence of the following conditions prior to screening: myocardial infarction, coronary bypass surgery, coronary artery angioplasty, unstable angina, clinically evident congestive heart failure, cardiac pacemaker, or cerebrovascular accident.
boolean
C0027051 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C0002997 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5])
C0030163 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
Cardiac Arrhythmia
Item
Cardiac arrhythmia: significant cardiac arrhythmia shown on screening ECG, or a known or suspected history of significant cardiac arrhythmias within six months prior to screening. i.e., pre- existing syndromes, sinus pause > 3 seconds, non-sustained ventricular tachycardia (3 consecutive ectopic beats), sustained ventricular tachycardia (30 consecutive ectopic beats), sustained supraventricular tachycardia (30 consecutive ectopic beats), accessory pathway tachycardia, bradycardia (heart rate < 45 beats per minute), atrial flutter, atrial fibrillation, ectopic pacemaker, sick sinus syndrome, ventricular block (second or third degree), or left bundle branch block patients with right bundle branch block with no other symptoms of vascular history and no other medical concerns as determined by the PI and the GSK monitor are permitted entry into the trial, consultation with the GSK medical monitor prior to entry is required. Uncontrolled atrial fibrillation/flutter (ventricular response rate ≥100 bpm) at the screening visit (Visit 1).
boolean
C0003811 (UMLS CUI [1])
Prolonged QT interval, Congenital qualifier; Electrocardiogram QT corrected interval prolonged
Item
History of congenital QT prolongation and/or QTc interval >450msec at screening visit (Visit 1) using the Bazett formula
boolean
C0151878 (UMLS CUI [1,1])
C1744681 (UMLS CUI [1,2])
C0855333 (UMLS CUI [2])
Systolic Pressure
Item
Systolic cuff BP > 150 mmHg in the seated position at screening visit (Visit1), if the initial supine measure is >150mmHg, repeat the measure in sequence times 3 within 5-10 minutes of the last measure and take the mean of the three measures, if the average is >150mmHg then the subject may not enter the trial.
boolean
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic cuff BP >95 mmHg in the seated position at screening visit (Visit 1), if the initial supine measure is >95mmHg, repeat the measure in sequence 3 times within 5-10 minutes of the last measure and take the average of the three measures, if the average is >95mmHg then the subject may not enter the trial.
boolean
C042883 (UMLS CUI [1])
Malignant Neoplasms
Item
History of malignancy within the past five years (other than squamous or basal cell skin cancer).
boolean
C0006826 (UMLS CUI [1])
Condition, interferes with, Sex Behavior
Item
Any condition which would preclude sexual activity.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0036864 (UMLS CUI [1,3])
Item Group
Concomitant Medications
C2347852 (UMLS CUI-1)
Concomitant Agent
Item
No concomitant medications know to impact IELT may be used within 7 days or 5 half lives (whichever is longer) of recording first IELT or at any time during the study this includes; SSRI’s, phosphodiesterase type 5 inhibitors, topical anesthetics muopioid antagonists, vacuum devices, constrictive devices, penile injections, urethral suppositories, gels, any over-the-counter herbal or non- prescription medications, and products purchased via the internet or mail order pharmacies, all other medications may be stopped at Visit 1 unless a period of tapering prior to discontinuation is required. During the course of the study the only cconcomitant medication use which can be considered includes inhaled or intra nasal agents for asthmatic patients and patients with allergic rhinitis, who are on stable doses of inhaled or intra nasal agents as prescribed by their health care providers, and who have had no adjustments in their prescribed and or actual use within the last 60 days. Agents which are known or expected to have significant systemic exposures as a result of inhaled or intra-nasal use or to have known CYP3A4 drug-drug interaction potential are not included in this exemption.
boolean
C2347852 (UMLS CUI [1])
Study Subject Participation Status, Investigational New Drugs
Item
Subjects who have received any investigational drug (including placebo) within 30 days of the screening visit or 5 half lives of the investigational drug whichever is longer (Visit 1).
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Item Group
Other Exclusion Criteria
C0680251 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Liver Diseases; Hepatic Impairment
Item
Severe chronic or acute liver disease, history of moderate (Child- Pugh B) or severe (Child-Pugh C) hepatic impairment.
boolean
C0023895 (UMLS CUI [1])
C0948807 (UMLS CUI [2])
GSK557296, Hypersensitivity; Investigational New Drugs, Hypersensitivity
Item
Subjects with known hypersensitivity to GSK557296 or any component of the investigational medication.
boolean
C3886683 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
Illiteracy; Comprehension, Unable
Item
Subjects who are illiterate or unable to understand the questionnaires or the subject diary.
boolean
C0020899 (UMLS CUI [1])
C0162340 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Subject Diary, Complete, Unwilling; Subject Diary, Complete, Unable
Item
Subjects who are unwilling or unable to complete the subject diary.
boolean
C3890583 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0034656 (UMLS CUI [1,3])
C3890583 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Randomization; Uniwlling
Item
Subjects who are unwilling to be randomized to placebo.
boolean
C0558080 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Partner in relationship, Pregnancy, Planned; Partner in relationship, Breast Feeding
Item
Subject whose sexual partner is actively trying to conceive, and or is unwilling to use a reliable form of birth control as outlined in Section 8.1 for the duration of the trial. Or whose female partner is breast feeding. If the male partner has been using condoms with their monogamous partner for a minimum of 4 months prior to consideration of enrollment in the trial and they will continue to use the same type of condoms for the duration of the trial without exception and for all IELT measures during screening and active treatment. Then they may be considered for entry into the trial. Condoms with topical anesthetic creams are not permitted and use of these will be considered an exclusion from participation in the trial. Condom use should be noted in the electron CRF.
boolean
C0682323 (UMLS CUI [1,1])
C0032992 (UMLS CUI [1,2])
C0682323 (UMLS CUI [2,1])
C0006147 (UMLS CUI [2,2])
Non-Compliance
Item
Subjects, who in the opinion of the investigator, would be non- compliant with the majority of the visits scheduled or study procedures.
boolean
C0457432 (UMLS CUI [1])
heparin, Hypersensitivity; Heparin-induced thrombocytopenia
Item
History of sensitivity to heparin or heparin-induced thrombocytopenia (for subjects at sites where PK studies are planned).
boolean
C0019134 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0272285 (UMLS CUI [2])
Cotinine measurement; Tobacco Use
Item
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 1 month prior to screening.
boolean
C0202363 (UMLS CUI [1,1])
C0543414 (UMLS CUI [1,2])
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