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To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an 8 week study period compared to placebo in men with primary premature ejaculation. An assessment of the safety and tolerability of all doses of GSK557296 will be performed as well as an assessment for change in the Index of Premature Ejaculation (IPE) from baseline and at the end of the 8 weeks of treatment. During the active treatment period study participants will be limited to a maximum of 40 doses of GSK557296, or placebo, spilt as 20 doses for both 4 week intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo |
|
| 50 mg | Active Comparator | 50 mg GSK557296 |
|
| 150 mg | Active Comparator | 150 mg GSK557296 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK557296 | Drug | 50 mg GSK557296 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation | Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05). | Up to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation | Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05). |
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Inclusion Criteria:
Exclusion Criteria:
Previous or Current Medical Conditions
Concomitant Medications
Abnormal Laboratory Values
Other exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | San Diego | California | 92120 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23937679 | Derived | Shinghal R, Barnes A, Mahar KM, Stier B, Giancaterino L, Condreay LD, Black L, McCallum SW. Safety and efficacy of epelsiban in the treatment of men with premature ejaculation: a randomized, double-blind, placebo-controlled, fixed-dose study. J Sex Med. 2013 Oct;10(10):2506-17. doi: 10.1111/jsm.12272. Epub 2013 Aug 12. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 109059 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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The study consisted of 4 weeks run-in period. Total 77 male participants with primary pre-mature ejaculation were enrolled and randomized. Out of these 65 participants completed the study.
The study was conducted at 6 sites in United States and 2 centers in the Netherlands during 23 December 2009 to 05 May 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received 3 placebo tablets matching study drug approximately one hour prior to planned sexual intercourse (SI), once in a 24-hour time period, on-demand for 8 weeks. |
| FG001 | GSK557296 50 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| GSK557296 |
| Drug |
150 mg GSK557296 |
|
|
| placebo | Drug | placebo |
|
| Up to Week 8 |
| Mean IELT Compared After the First Dose of Study Drug or Placebo | Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. For GSK557296 50 mg and 150 mg: LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster using placebo, GSK557296 50 mg and GSK557296 150 mg treatments. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05). | Up to Week 8 |
| Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation | Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participants with a Baseline and a post-Baseline IELT value were included. | Baseline and up to Week 8 |
| Mean Change From Baseline in IELT Compared After the First Dose of Study Drug or Placebo | Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participant with a Baseline IELT and a valid first attempt were included. | Baseline and Week 4 |
| Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] and From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] of GSK557296 | The pharmacokinetic (PK ) visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded. | At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization |
| Maximum Observed Plasma Concentration (Cmax) of GSK557296 | The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded. | At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization |
| Time of Occurrence of Maximum Observed Plasma Concentration (Tmax) of GSK557296 | The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded. | At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP were taken in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position. | Baseline and up to follow up (post treatment 48 hours) |
| Mean Change From Baseline in Heart Rate | Heart rate assessment was done in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position. | Baseline and up to follow up (post treatment 48 hours) |
| Mean Change From Baseline in Electrocardiogram (ECG) Values | ECG parameter values for QT interval, QT duration corrected for heart rate by Fridericia's formula (QTc [Fridericia]), QT duration corrected for heart rate by Bazett's formula (QTc [Bazett]), PR Interval and QRS Duration were assessed. The Baseline ECG was the latest ECG recorded on or before the participant's Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. | Baseline and up to follow up (post treatment 48 hours) |
| Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) | Serum laboratory parameters: Albumin, Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Direct bilirubin, Total Bilirubin (T. Bilirubin), Calcium, Chloride, Carbon dioxide content/Bicarbonate (CO2/HCO3), Creatinine, Gamma glutamyl transferase (GGT), Glucose, Potassium, Sodium, Total protein (T. Protein), Urea/Blood urea nitrogen (BUN) and Uric acid were assessed. Baseline laboratory values were the latest values obtained on or before the participant's Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value. | Baseline and up to follow up (post treatment 48 hours) |
| Number of Participants With Shift From Baseline in Additional Lab Parameters (Free T3, Prostate Specific Antigen [PSA], Thyroid Stimulating Hormone [TSH] and Total Testosterone) | Baseline laboratory values were the latest values obtained on or before the participant's Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value. | Baseline and up to follow up (post treatment 48 hours) |
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. On-treatment adverse events were those started on or after the first dose of study medication and on or before the last dose of study medication. | Baseline and up to follow up (post treatment 48 hours) |
| Number of Participants With Dose/Exposure Response Relationship Using PK/Pharmacodynamics (PD) Modeling | The relationship between plasma concentrations of GSK557296 and selected endpoints were planned to be explored using appropriate PK/PD models. | Up to Week 8 |
| San Jose |
| California |
| 95128 |
| United States |
| GSK Investigational Site | Fort Wayne | Indiana | 46825 | United States |
| GSK Investigational Site | New York | New York | 10016 | United States |
| GSK Investigational Site | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| GSK Investigational Site | Amsterdam | 1081 HV | Netherlands |
| GSK Investigational Site | Utrecht | 3584 CJ | Netherlands |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109059 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109059 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109059 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109059 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109059 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109059 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
Participants received one 50 milligrams (mg) tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
| FG002 | GSK557296 150 mg | Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks. |
| BG001 | GSK557296 50 mg | Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks. |
| BG002 | GSK557296 150 mg | Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation | Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05). | Intent to Treat (ITT) Population consisted of all participants randomized to study treatment. Only those participants with data available at the indicated time points were analyzed. | Posted | Geometric Mean | Standard Error | minutes | Up to Week 8 |
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| Secondary | Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation | Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05). | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Geometric Mean | Standard Error | minutes | Up to Week 8 |
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| Secondary | Mean IELT Compared After the First Dose of Study Drug or Placebo | Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. For GSK557296 50 mg and 150 mg: LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster using placebo, GSK557296 50 mg and GSK557296 150 mg treatments. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p < 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05). | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Geometric Mean | Standard Error | minutes | Up to Week 8 |
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| Secondary | Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation | Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participants with a Baseline and a post-Baseline IELT value were included. | ITT Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | minutes | Baseline and up to Week 8 |
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| Secondary | Mean Change From Baseline in IELT Compared After the First Dose of Study Drug or Placebo | Male participants needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. First dose IELT was the IELT value associated with the first valid SI attempt made during the treatment period. Baseline IELT was calculated as the arithmetic mean IELT from valid screening SI attempts. If multiple screening SI attempts were made on the same calendar day, only the IELT from the first attempt was used in the calculation of Baseline IELT. Change from Baseline IELT was calculated by subtracting the Baseline IELT (arithmetic mean IELT from valid screening attempts) from the on-treatment IELT (median IELT from valid on-treatment attempts). Only participant with a Baseline IELT and a valid first attempt were included. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | minutes | Baseline and Week 4 |
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| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] and From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] of GSK557296 | The pharmacokinetic (PK ) visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded. | PK Population consisted of all participants from whom a PK sample had been obtained and analyzed. Only those participants with data available at the indicated time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours times nanograms per milliliters | At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of GSK557296 | The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded. | PK Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter (ng/mL) | At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization |
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| Secondary | Time of Occurrence of Maximum Observed Plasma Concentration (Tmax) of GSK557296 | The PK visit was not needed to take place at visit 2 but supposed to be completed before visit 3. The participants were asked to fast overnight prior to their PK sampling day and the time of their last meal was recorded. | PK Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization |
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| Secondary | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP and DBP were taken in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position. | The Safety Population consisted of all participants randomized to study treatment who received at least one dose of study drug. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Millimeters of mercury | Baseline and up to follow up (post treatment 48 hours) |
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| Secondary | Mean Change From Baseline in Heart Rate | Heart rate assessment was done in a seated position. If the single measure was outside the cut off value, the mean of three seated measures were taken approximately 5-10 minutes apart was recorded. Baseline value was the latest values obtained on or before the Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. Per-participant values for all vital sign measures were taken as the mean of all reported values on a given date, regardless of recorded position. | Safety Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Beats per minute | Baseline and up to follow up (post treatment 48 hours) |
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| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Values | ECG parameter values for QT interval, QT duration corrected for heart rate by Fridericia's formula (QTc [Fridericia]), QT duration corrected for heart rate by Bazett's formula (QTc [Bazett]), PR Interval and QRS Duration were assessed. The Baseline ECG was the latest ECG recorded on or before the participant's Baseline reference date. Change from Baseline was the value at any visit post-Baseline minus value at Baseline. | Safety Population. Only those participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Milliseconds | Baseline and up to follow up (post treatment 48 hours) |
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| Secondary | Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) | Serum laboratory parameters: Albumin, Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Direct bilirubin, Total Bilirubin (T. Bilirubin), Calcium, Chloride, Carbon dioxide content/Bicarbonate (CO2/HCO3), Creatinine, Gamma glutamyl transferase (GGT), Glucose, Potassium, Sodium, Total protein (T. Protein), Urea/Blood urea nitrogen (BUN) and Uric acid were assessed. Baseline laboratory values were the latest values obtained on or before the participant's Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value. | Safety Population. Only those participants available at the specified time points were analyzed. | Posted | Number | Participants | Baseline and up to follow up (post treatment 48 hours) |
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| Secondary | Number of Participants With Shift From Baseline in Additional Lab Parameters (Free T3, Prostate Specific Antigen [PSA], Thyroid Stimulating Hormone [TSH] and Total Testosterone) | Baseline laboratory values were the latest values obtained on or before the participant's Baseline reference date. Unscheduled laboratory values were summarized as at-visit values only in the event that an at-visit laboratory value was missing. The values were presented as high, low or normal values shifted from Baseline value. | Safety Population. Only those participants available at the specified time points were analyzed. | Posted | Number | Participants | Baseline and up to follow up (post treatment 48 hours) |
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| Secondary | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. On-treatment adverse events were those started on or after the first dose of study medication and on or before the last dose of study medication. | Safety Population. | Posted | Number | Participants | Baseline and up to follow up (post treatment 48 hours) |
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| Secondary | Number of Participants With Dose/Exposure Response Relationship Using PK/Pharmacodynamics (PD) Modeling | The relationship between plasma concentrations of GSK557296 and selected endpoints were planned to be explored using appropriate PK/PD models. | ITT Population. Data was not collected for this outcome measure. | Posted | Up to Week 8 |
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All SAEs and non SAEs were collected through out the study treatment (8 weeks) and up to follow up (post treatment 48 hours)
On-treatment SAEs and AEs are reported for safety Population, which consisted of all participants randomized to study treatment who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks. | 0 | 25 | 0 | 25 | 8 | 25 |
| EG001 | GSK557296 50 mg | Participants received one 50 mg tablet of study drug and two placebo tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks. | 0 | 22 | 0 | 22 | 6 | 22 |
| EG002 | GSK557296 150 mg | Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks. | 0 | 28 | 0 | 28 | 10 | 28 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Genital discomfort | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 14.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA 14.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C571185 | epelsiban |
| C509172 | MG 50-3-1 |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 0.6161 |
| Geometric LS Mean Fold Difference |
| 1.11 |
| 2-Sided |
| 95 |
| 0.74 |
| 1.65 |
Estimated value is Geometric LS Mean Fold Difference from Placebo. |
| Superiority or Other |
| ANCOVA | 0.4971 | Geometric LS Mean Fold Difference | 1.13 | 2-Sided | 95 | 0.79 | 1.61 | Estimated value is Geometric LS Mean Fold Difference from Placebo. | Superiority or Other |
| OG002 | GSK557296 150 mg | Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks. |
| OG003 | Pooled GSK557296 | These were pooled participants population from the groups who received GSK55729650 mg and 150 mg. |
|
|
|
| OG002 | GSK557296 150 mg | Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks. |
| OG003 | Pooled GSK557296 | These were pooled participants population from the groups who received GSK55729650 mg and 150 mg. |
|
|
|
| OG002 | GSK557296 150 mg | Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks. |
| OG003 | Pooled GSK557296 | These were pooled participants population from the groups who received GSK55729650 mg and 150 mg. |
|
|
| OG002 | GSK557296 150 mg | Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks. |
| OG003 | Pooled GSK557296 | These were pooled participants population from the groups who received GSK55729650 mg and 150 mg. |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks. |
|
|
|
|
|
|
| OG002 |
| GSK557296 150 mg |
Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks. |
|
|
|
|
Participants received three 50 mg tablets of study drug approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.
|
|
| Participants |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|