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Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059 - Liver Events

- 17/11/21 - 1 Formulier, 5 Itemgroepen, 17 Data-elementen, 1 Taal

Itemgroepen: Liver Dysfunction or Failure by Clinical Classification Adverse Event, Serious Adverse Event, Liver Dysfunction or Failure by Clinical Classification Adverse Event, Notifications, Liver function, Laboratory procedures, Medical History, Experimental Drug, Liver

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

Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484 - Liver Event

- 17/5/20 - 1 Formulier, 10 Itemgroepen, 96 Data-elementen, 1 Taal

Itemgroepen: Date of visit, Liver, Adverse Event, Liver, Adverse Event, Experimental drug, Liver, Adverse event, Pharmacokinetic aspects, Liver, Adverse Event, Disease, Liver, Adverse Event, Drug-related disorder, Liver, Adverse Event, Disease, Other, Liver, Adverse Event, Alcohol consumption, Liver, Adverse Event, Imaging of liver, Liver, Adverse Event, Biopsy of liver

Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059 - Liver Biopsy

- 13/11/18 - 1 Formulier, 1 Itemgroep, 14 Data-elementen, 1 Taal

Itemgroep: Biopsy of liver

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

Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059 - Liver Imaging

- 13/11/18 - 1 Formulier, 1 Itemgroep, 11 Data-elementen, 1 Taal

Itemgroep: Imaging of liver

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

Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059 - Logs and Repeats

- 6/11/18 - 1 Formulier, 3 Itemgroepen, 12 Data-elementen, 1 Taal

Itemgroepen: Date of visit, Assessment date, Adverse Event; Concomitant Agent; Assessed, Liver, Adverse Event

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

Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059 - Medical Conditions at Onset of Liver Event

- 13/11/18 - 1 Formulier, 4 Itemgroepen, 24 Data-elementen, 1 Taal

Itemgroepen: Liver Disease, Disease, Liver Disease, Drug-related disorder, Liver Disease, Other, Other diseases or conditions

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

Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059 - Alcohol Intake at Onset of Liver Event

- 11/11/18 - 1 Formulier, 1 Itemgroep, 3 Data-elementen, 1 Taal

Itemgroep: Liver Dysfunction or Failure by Clinical Classification Adverse Event, Alcohol consumption, Onset

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

Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484 - Logs/Repeats

- 27/9/21 - 1 Formulier, 12 Itemgroepen, 130 Data-elementen, 1 Taal

Itemgroepen: Date of visit, Assessment Date, Adverse Event; Concomitant Agent; Evaluation, Repeat, Liver, Adverse Event, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Laboratory Procedures, Urinalysis, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Repeat, Pharmacokinetic aspect, Blood, Repeat

Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

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