Trial Outcomes & Findings for A Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Study in Men With Premature Ejaculation (NCT NCT01021553)

NCT ID: NCT01021553

Last Updated: 2017-09-12

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 77 participants
• Primary outcome timeframe: Up to Week 8
• Results posted on: 2017-09-12

Participant Flow

The study was conducted at 6 sites in United States and 2 centers in the Netherlands during 23 December 2009 to 05 May 2011.

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.

Participant milestones

Measure	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.	GSK557296 50 mg 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.	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.
Overall Study STARTED	27	22	28
Overall Study COMPLETED	23	17	25
Overall Study NOT COMPLETED	4	5	3

Reasons for withdrawal

Measure	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.	GSK557296 50 mg 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.	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.
Overall Study Adverse Event	1	0	0
Overall Study Lack of Efficacy	2	2	0
Overall Study Protocol Violation	0	2	2
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrawal by Subject	1	1	0

Baseline Characteristics

A Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Study in Men With Premature Ejaculation

Baseline characteristics by cohort

Measure	Placebo n=27 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=22 Participants 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.	GSK557296 150 mg n=28 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.	Total n=77 Participants Total of all reporting groups
Age, Continuous	38.4 Years STANDARD_DEVIATION 8.90 • n=5 Participants	37.9 Years STANDARD_DEVIATION 9.85 • n=7 Participants	34.0 Years STANDARD_DEVIATION 9.00 • n=5 Participants	36.7 Years STANDARD_DEVIATION 9.31 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	22 Participants n=7 Participants	28 Participants n=5 Participants	77 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	20 Participants n=7 Participants	21 Participants n=5 Participants	65 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to Week 8

Population: 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.

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).

Outcome measures

Measure	Placebo n=25 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=20 Participants 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.	GSK557296 150 mg n=26 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.	Pooled GSK557296 n=46 Participants These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation	0.62 minutes Standard Error 0.090	0.72 minutes Standard Error 0.117	0.69 minutes Standard Error 0.099	0.71 minutes Standard Error 0.075

SECONDARY outcome

Timeframe: Up to Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

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).

Outcome measures

Measure	Placebo n=27 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=22 Participants 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.	GSK557296 150 mg n=28 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.	Pooled GSK557296 n=50 Participants These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation Week 0 to 4	0.67 minutes Standard Error 0.095	0.69 minutes Standard Error 0.109	0.67 minutes Standard Error 0.094	0.68 minutes Standard Error 0.071
Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation Week 4 to 8	0.65 minutes Standard Error 0.110	0.86 minutes Standard Error 0.168	0.70 minutes Standard Error 0.118	0.77 minutes Standard Error 0.097

SECONDARY outcome

Timeframe: Up to Week 8

Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.

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).

Outcome measures

Measure	Placebo n=25 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=20 Participants 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.	GSK557296 150 mg n=26 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.	Pooled GSK557296 n=46 Participants These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
Mean IELT Compared After the First Dose of Study Drug or Placebo	0.60 minutes Standard Error 0.116	0.68 minutes Standard Error 0.146	0.57 minutes Standard Error 0.109	0.61 minutes Standard Error 0.088

SECONDARY outcome

Timeframe: Baseline and up to Week 8

Population: ITT Population. Only those participants available at the specified time points were analyzed.

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.

Outcome measures

Measure	Placebo n=27 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=22 Participants 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.	GSK557296 150 mg n=28 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.	Pooled GSK557296 n=50 Participants These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation Week 0 to 4	0.29 minutes Standard Deviation 0.510	0.74 minutes Standard Deviation 2.061	1.26 minutes Standard Deviation 3.493	1.03 minutes Standard Deviation 2.939
Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation Week 4 to 8	0.38 minutes Standard Deviation 0.940	1.24 minutes Standard Deviation 2.869	1.30 minutes Standard Deviation 2.853	1.27 minutes Standard Deviation 2.823
Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation Week 0 to 8	0.26 minutes Standard Deviation 0.481	0.91 minutes Standard Deviation 2.406	1.24 minutes Standard Deviation 3.085	1.10 minutes Standard Deviation 2.786

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: ITT Population. Only those participants with data available at the indicated time points were analyzed.

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.

Outcome measures

Measure	Placebo n=25 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=20 Participants 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.	GSK557296 150 mg n=26 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.	Pooled GSK557296 n=46 Participants These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
Mean Change From Baseline in IELT Compared After the First Dose of Study Drug or Placebo	0.33 minutes Standard Deviation 0.750	0.73 minutes Standard Deviation 2.003	0.93 minutes Standard Deviation 3.191	0.84 minutes Standard Deviation 2.713

SECONDARY outcome

Timeframe: At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization

Population: 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.

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.

Outcome measures

Measure	Placebo n=21 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=28 Participants 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.	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.	Pooled GSK557296 These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
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 AUC (0-inf)	854.1 Hours times nanograms per milliliters Geometric Coefficient of Variation 45	2485.9 Hours times nanograms per milliliters Geometric Coefficient of Variation 33	—	—
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 AUC (0-t)	772.9 Hours times nanograms per milliliters Geometric Coefficient of Variation 43	2304.2 Hours times nanograms per milliliters Geometric Coefficient of Variation 31	—	—

SECONDARY outcome

Timeframe: At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

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.

Outcome measures

Measure	Placebo n=21 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=28 Participants 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.	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.	Pooled GSK557296 These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
Maximum Observed Plasma Concentration (Cmax) of GSK557296	387.2 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 49	1405.1 Nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41	—	—

SECONDARY outcome

Timeframe: At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization

Population: PK Population. Only those participants with data available at the indicated time points were analyzed.

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.

Outcome measures

Measure	Placebo n=21 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=28 Participants 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.	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.	Pooled GSK557296 These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
Time of Occurrence of Maximum Observed Plasma Concentration (Tmax) of GSK557296	0.6 hours Geometric Coefficient of Variation 43	0.4 hours Geometric Coefficient of Variation 51	—	—

SECONDARY outcome

Timeframe: Baseline and up to follow up (post treatment 48 hours)

Population: 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.

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.

Outcome measures

Measure	Placebo n=25 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=22 Participants 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.	GSK557296 150 mg n=28 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.	Pooled GSK557296 These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 8	0.188 Millimeters of mercury Standard Deviation 7.8127	1.529 Millimeters of mercury Standard Deviation 6.9245	-0.897 Millimeters of mercury Standard Deviation 8.8300	—
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 4	0.422 Millimeters of mercury Standard Deviation 8.5478	-2.472 Millimeters of mercury Standard Deviation 9.3388	-0.550 Millimeters of mercury Standard Deviation 8.8500	—
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 8	1.290 Millimeters of mercury Standard Deviation 9.1774	-0.657 Millimeters of mercury Standard Deviation 11.1552	-4.268 Millimeters of mercury Standard Deviation 13.4694	—
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 4	-0.226 Millimeters of mercury Standard Deviation 7.5436	-2.036 Millimeters of mercury Standard Deviation 7.3751	-0.485 Millimeters of mercury Standard Deviation 6.7274	—

SECONDARY outcome

Timeframe: Baseline and up to follow up (post treatment 48 hours)

Population: Safety Population. Only those participants available at the specified time points were analyzed.

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.

Outcome measures

Measure	Placebo n=25 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=22 Participants 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.	GSK557296 150 mg n=28 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.	Pooled GSK557296 These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
Mean Change From Baseline in Heart Rate Week 4	0.319 Beats per minute Standard Deviation 8.4404	1.821 Beats per minute Standard Deviation 10.5332	3.240 Beats per minute Standard Deviation 9.8555	—
Mean Change From Baseline in Heart Rate Week 8	2.428 Beats per minute Standard Deviation 6.9642	2.221 Beats per minute Standard Deviation 6.2480	0.279 Beats per minute Standard Deviation 7.8860	—

SECONDARY outcome

Timeframe: Baseline and up to follow up (post treatment 48 hours)

Population: Safety Population. Only those participants available at the specified time points were analyzed.

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.

Outcome measures

Measure	Placebo n=25 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=22 Participants 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.	GSK557296 150 mg n=28 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.	Pooled GSK557296 These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
Mean Change From Baseline in Electrocardiogram (ECG) Values QT Interval, Week 8	-3.1 Milliseconds Standard Deviation 17.16	-0.4 Milliseconds Standard Deviation 20.17	-4.9 Milliseconds Standard Deviation 21.12	—
Mean Change From Baseline in Electrocardiogram (ECG) Values PR Interval, Week 4	-2.6 Milliseconds Standard Deviation 7.32	-3.1 Milliseconds Standard Deviation 10.05	1.0 Milliseconds Standard Deviation 15.22	—
Mean Change From Baseline in Electrocardiogram (ECG) Values QRS Duration, Week 8	-2.0 Milliseconds Standard Deviation 4.99	1.0 Milliseconds Standard Deviation 4.15	1.3 Milliseconds Standard Deviation 8.35	—
Mean Change From Baseline in Electrocardiogram (ECG) Values QT Interval, Week 4	1.8 Milliseconds Standard Deviation 19.52	-2.5 Milliseconds Standard Deviation 25.42	-0.1 Milliseconds Standard Deviation 21.35	—
Mean Change From Baseline in Electrocardiogram (ECG) Values QTc (Fridericia), Week 4	1.5 Milliseconds Standard Deviation 11.98	-3.1 Milliseconds Standard Deviation 12.77	-9.2 Milliseconds Standard Deviation 13.18	—
Mean Change From Baseline in Electrocardiogram (ECG) Values QTc (Fridericia), Week 8	-5.7 Milliseconds Standard Deviation 8.07	5.4 Milliseconds Standard Deviation 7.23	-3.6 Milliseconds Standard Deviation 17.42	—
Mean Change From Baseline in Electrocardiogram (ECG) Values QTc (Bazett), Week 4	0.4 Milliseconds Standard Deviation 18.50	-1.0 Milliseconds Standard Deviation 15.80	-4.2 Milliseconds Standard Deviation 16.07	—
Mean Change From Baseline in Electrocardiogram (ECG) Values QTc (Bazett), Week 8	-1.7 Milliseconds Standard Deviation 15.88	3.4 Milliseconds Standard Deviation 17.52	-4.2 Milliseconds Standard Deviation 17.38	—
Mean Change From Baseline in Electrocardiogram (ECG) Values PR Interval, Week 8	-2.5 Milliseconds Standard Deviation 10.40	-3.1 Milliseconds Standard Deviation 9.49	0.4 Milliseconds Standard Deviation 15.88	—
Mean Change From Baseline in Electrocardiogram (ECG) Values QRS Duration, Week 4	-1.9 Milliseconds Standard Deviation 5.17	2.1 Milliseconds Standard Deviation 7.40	0.6 Milliseconds Standard Deviation 8.38	—

SECONDARY outcome

Timeframe: Baseline and up to follow up (post treatment 48 hours)

Population: Safety Population. Only those participants available at the specified time points were analyzed.

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.

Outcome measures

Measure	Placebo n=27 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=22 Participants 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.	GSK557296 150 mg n=28 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.	Pooled GSK557296 These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Albumin, Week 4, normal to high	1 Participants	2 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Albumin, Week 8, low to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) AP, Week 4, high to normal	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) AP, Week 4, normal to high	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) AP, Week 8, high to normal	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) ALT, Week 8, normal to high	0 Participants	1 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Calcium, Week 4, low to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Potassium, Week 8, low to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Sodium, Week 4, normal to high	0 Participants	1 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Sodium, Week 8, high to normal	0 Participants	1 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Urea/BUN, Week 4, low to normal	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Uric acid, Week 4, high to normal	1 Participants	1 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Uric acid, Week 4, normal to high	1 Participants	0 Participants	2 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Uric acid, Week 4, low to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Uric acid, Week 8, low to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Uric acid, Week 8, high to normal	0 Participants	1 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Chloride, Week 8, high to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Chloride, Week 8, normal to high	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Albumin, Week 4, high to normal	2 Participants	1 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Albumin, Week 4, low to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Albumin, Week 8, high to normal	1 Participants	1 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Albumin, Week 8, normal to high	1 Participants	1 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) ALT, Week 4, high to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) ALT, Week 4, normal to high	1 Participants	1 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) ALT, Week 8, high to normal	2 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) AST, Week 4, normal to high	0 Participants	1 Participants	2 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) AST, Week 8, normal to high	0 Participants	1 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) T. Bilirubin, Week 4, normal to high	2 Participants	1 Participants	2 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) T. Bilirubin, Week 4, high to normal	0 Participants	0 Participants	4 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) T. Bilirubin, Week 8, high to normal	2 Participants	0 Participants	4 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) T. Bilirubin, Week 8, normal to high	0 Participants	1 Participants	2 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Calcium, Week 4, high to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Calcium, Week 4, normal to high	1 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Calcium, Week 8, high to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Calcium, Week 8, normal to high	2 Participants	0 Participants	2 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Calcium, Week 8, low to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Chloride, Week 4, high to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Chloride, Week 4, normal to high	1 Participants	2 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) CO2/HCO3, Week 4, normal to low	2 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) CO2/HCO3, Week 4, low to normal	2 Participants	3 Participants	2 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) CO2/HCO3, Week 8, normal to low	1 Participants	0 Participants	2 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) CO2/HCO3, Week 8, low to normal	2 Participants	3 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Creatinine, Week 4, normal to high	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Creatinine, Week 8, normal to high	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) GGT, Week 4, high to normal	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) GGT, Week 4, normal to high	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) GGT, Week 8, high to normal	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) GGT, Week 8, normal to high	0 Participants	0 Participants	2 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Glucose, Week 4, high to normal	1 Participants	2 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Glucose, Week 4, normal to high	3 Participants	2 Participants	2 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Glucose, Week 4, low to normal	1 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Glucose, Week 4, normal to low	0 Participants	1 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Glucose, Week 8, high to normal	2 Participants	1 Participants	3 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Glucose, Week 8, normal to high	2 Participants	4 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Glucose, Week 8, low to high	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Glucose, Week 8, low to normal	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Potassium, Week 4, low to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Sodium, Week 4, high to normal	0 Participants	1 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) T. Protein, Week 8, low to normal	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Urea/BUN, Week 4, high to normal	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Urea/BUN, Week 4, normal to high	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Urea/BUN, Week 8, high to normal	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Uric acid, Week 4, normal to low	0 Participants	0 Participants	1 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Uric acid, Week 8, normal to high	1 Participants	0 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry) Uric acid, Week 8, normal to low	0 Participants	0 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Baseline and up to follow up (post treatment 48 hours)

Population: Safety Population. Only those participants available at the specified time points were analyzed.

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.

Outcome measures

Measure	Placebo n=25 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=22 Participants 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.	GSK557296 150 mg n=28 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.	Pooled GSK557296 These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
Number of Participants With Shift From Baseline in Additional Lab Parameters (Free T3, Prostate Specific Antigen [PSA], Thyroid Stimulating Hormone [TSH] and Total Testosterone) Free T3, Week 4, high to nomal	0 Participants	1 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Additional Lab Parameters (Free T3, Prostate Specific Antigen [PSA], Thyroid Stimulating Hormone [TSH] and Total Testosterone) Free T3, Week 8, high to nomal	0 Participants	1 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Additional Lab Parameters (Free T3, Prostate Specific Antigen [PSA], Thyroid Stimulating Hormone [TSH] and Total Testosterone) TSH, Week 4, normal to low	0 Participants	1 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Additional Lab Parameters (Free T3, Prostate Specific Antigen [PSA], Thyroid Stimulating Hormone [TSH] and Total Testosterone) TSH, Week 8, normal to high	0 Participants	1 Participants	0 Participants	—
Number of Participants With Shift From Baseline in Additional Lab Parameters (Free T3, Prostate Specific Antigen [PSA], Thyroid Stimulating Hormone [TSH] and Total Testosterone) Testosterone, Week 8, normal to low	1 Participants	1 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Baseline and up to follow up (post treatment 48 hours)

Population: Safety Population.

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.

Outcome measures

Measure	Placebo n=25 Participants Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=22 Participants 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.	GSK557296 150 mg n=28 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.	Pooled GSK557296 These were pooled participants population from the groups who received GSK55729650 mg and 150 mg.
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Any AEs	8 Participants	6 Participants	10 Participants	—
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Any SAEs	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Up to Week 8

Population: ITT Population. Data was not collected for this outcome measure.

The relationship between plasma concentrations of GSK557296 and selected endpoints were planned to be explored using appropriate PK/PD models.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

GSK557296 50 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

GSK557296 150 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=25 participants at risk Participants received 3 tablets approximately one hour prior to planned SI, once in a 24-hour time period, on-demand for 8 weeks.	GSK557296 50 mg n=22 participants at risk 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.	GSK557296 150 mg n=28 participants at risk 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.
Nervous system disorders Headache	12.0% 3/25 • 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.	13.6% 3/22 • 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.	17.9% 5/28 • 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.
Nervous system disorders Hyperaesthesia	0.00% 0/25 • 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.	0.00% 0/22 • 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.	3.6% 1/28 • 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.
Nervous system disorders Presyncope	8.0% 2/25 • 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.	0.00% 0/22 • 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.	0.00% 0/28 • 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.
General disorders Fatigue	0.00% 0/25 • 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.	0.00% 0/22 • 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.	3.6% 1/28 • 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.
General disorders Influenza like illness	4.0% 1/25 • 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.	4.5% 1/22 • 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.	0.00% 0/28 • 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.
General disorders Irritability	0.00% 0/25 • 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.	4.5% 1/22 • 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.	0.00% 0/28 • 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.
General disorders Thirst	0.00% 0/25 • 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.	0.00% 0/22 • 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.	3.6% 1/28 • 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.
Infections and infestations Nasopharyngitis	8.0% 2/25 • 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.	0.00% 0/22 • 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.	3.6% 1/28 • 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.0% 1/25 • 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.	0.00% 0/22 • 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.	3.6% 1/28 • 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.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.0% 1/25 • 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.	0.00% 0/22 • 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.	0.00% 0/28 • 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.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/25 • 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.	0.00% 0/22 • 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.	3.6% 1/28 • 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.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/25 • 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.	0.00% 0/22 • 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.	3.6% 1/28 • 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.
Reproductive system and breast disorders Genital discomfort	0.00% 0/25 • 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.	0.00% 0/22 • 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.	3.6% 1/28 • 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.
Reproductive system and breast disorders Testicular pain	4.0% 1/25 • 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.	0.00% 0/22 • 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.	0.00% 0/28 • 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.
Eye disorders Blepharospasm	0.00% 0/25 • 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.	4.5% 1/22 • 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.	0.00% 0/28 • 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.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/25 • 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.	4.5% 1/22 • 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.	0.00% 0/28 • 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.
Investigations Blood bilirubin increased	4.0% 1/25 • 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.	0.00% 0/22 • 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.	0.00% 0/28 • 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.
Psychiatric disorders Insomnia	0.00% 0/25 • 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.	4.5% 1/22 • 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.	0.00% 0/28 • 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.
Surgical and medical procedures Tooth extraction	0.00% 0/25 • 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.	4.5% 1/22 • 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.	0.00% 0/28 • 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.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER