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32542

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

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Versions (1)
  1. 11/6/18 11/6/18 -
Copyright Holder

GlaxoSmithKline

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November 6, 2018

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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

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

    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.
    Description

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

    Data type

    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).
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Exclusion Criteria
    Description

    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).
    Description

    Liver diseases; Abnormality of the liver; Biliary tract abnormality

    Data type

    boolean

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

    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.
    Description

    Prostatitis

    Data type

    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.
    Description

    Disease; Mental disorders; Substance Use Disorders

    Data type

    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.
    Description

    Penis, Abnormality, Antatomic

    Data type

    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.
    Description

    Penis, Implant, Erectile Dysfunction

    Data type

    boolean

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

    Hypoactive Sexual Desire Disorder

    Data type

    boolean

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

    Spinal Cord Injuries

    Data type

    boolean

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

    Seizures

    Data type

    boolean

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

    Prostate carcinoma

    Data type

    boolean

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

    Prostatectomy; Prostate, Procedure

    Data type

    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.
    Description

    hematological disease, chronic disease

    Data type

    boolean

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

    Peptic Ulcer, Active disease diagnosis

    Data type

    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.
    Description

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

    Data type

    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).
    Description

    Cardiac Arrhythmia

    Data type

    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
    Description

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

    Data type

    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.
    Description

    Systolic Pressure

    Data type

    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.
    Description

    Diastolic blood pressure

    Data type

    boolean

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

    Malignant Neoplasms

    Data type

    boolean

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

    Condition, interferes with, Sex Behavior

    Data type

    boolean

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

    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.
    Description

    Concomitant Agent

    Data type

    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).
    Description

    Study Subject Participation Status, Investigational New Drugs

    Data type

    boolean

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

    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.
    Description

    Liver Diseases; Hepatic Impairment

    Data type

    boolean

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

    GSK557296, Hypersensitivity; Investigational New Drugs, Hypersensitivity

    Data type

    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.
    Description

    Illiteracy; Comprehension, Unable

    Data type

    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.
    Description

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

    Data type

    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.
    Description

    Randomization; Uniwlling

    Data type

    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.
    Description

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

    Data type

    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.
    Description

    Non-Compliance

    Data type

    boolean

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

    heparin, Hypersensitivity; Heparin-induced thrombocytopenia

    Data type

    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.
    Description

    Cotinine measurement; Tobacco Use

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0202363
    UMLS CUI [1,2]
    C0543414
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    Eligibility

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