Trial · NCT01021553

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

NCT01021553, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-09-12

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Study in Men With Premature Ejaculation. Trials, record NCT01021553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01021553

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT01021553
Status: Completed
Phases: Phase 2
Enrollment: 77 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Premature Ejaculation
Interventions: GSK557296, GSK557296, placebo
First posted: 2009-11-30
Last updated: 2017-09-12
Results first posted: 2017-09-12

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation	Up to Week 8	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).
Secondary	Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation	Up to Week 8	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).
Secondary	Mean IELT Compared After the First Dose of Study Drug or Placebo	Up to Week 8	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).
Secondary	Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation	Baseline and up to Week 8	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.
Secondary	Mean Change From Baseline in IELT Compared After the First Dose of Study Drug or Placebo	Baseline and Week 4	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.
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	At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization	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.
Secondary	Maximum Observed Plasma Concentration (Cmax) of GSK557296	At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization	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.
Secondary	Time of Occurrence of Maximum Observed Plasma Concentration (Tmax) of GSK557296	At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization	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.
Secondary	Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Baseline and up to follow up (post treatment 48 hours)	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.
Secondary	Mean Change From Baseline in Heart Rate	Baseline and up to follow up (post treatment 48 hours)	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.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation	Up to Week 8	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.	minutes	GEOMETRIC_MEAN
SECONDARY	Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation	Up to Week 8	ITT Population. Only those participants available at the specified time points were analyzed.	minutes	GEOMETRIC_MEAN
SECONDARY	Mean IELT Compared After the First Dose of Study Drug or Placebo	Up to Week 8	ITT Population. Only those participants with data available at the indicated time points were analyzed.	minutes	GEOMETRIC_MEAN
SECONDARY	Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation	Baseline and up to Week 8	ITT Population. Only those participants available at the specified time points were analyzed.	minutes	MEAN
SECONDARY	Mean Change From Baseline in IELT Compared After the First Dose of Study Drug or Placebo	Baseline and Week 4	ITT Population. Only those participants with data available at the indicated time points were analyzed.	minutes	MEAN
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	At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization	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.	Hours times nanograms per milliliters	GEOMETRIC_MEAN
SECONDARY	Maximum Observed Plasma Concentration (Cmax) of GSK557296	At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization	PK Population. Only those participants with data available at the indicated time points were analyzed.	Nanograms per milliliter (ng/mL)	GEOMETRIC_MEAN
SECONDARY	Time of Occurrence of Maximum Observed Plasma Concentration (Tmax) of GSK557296	At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization	PK Population. Only those participants with data available at the indicated time points were analyzed.	hours	GEOMETRIC_MEAN
SECONDARY	Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	Baseline and up to follow up (post treatment 48 hours)	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.	Millimeters of mercury	MEAN
SECONDARY	Mean Change From Baseline in Heart Rate	Baseline and up to follow up (post treatment 48 hours)	Safety Population. Only those participants available at the specified time points were analyzed.	Beats per minute	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group304

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation	Placebo		0.62	Standard Error 0.090	minutes
Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation	GSK557296 50 mg		0.72	Standard Error 0.117	minutes
Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation	GSK557296 150 mg		0.69	Standard Error 0.099	minutes
Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation	Pooled GSK557296		0.71	Standard Error 0.075	minutes
Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation	Placebo	Week 0 to 4	0.67	Standard Error 0.095	minutes
Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation	GSK557296 50 mg	Week 0 to 4	0.69	Standard Error 0.109	minutes
Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation	GSK557296 150 mg	Week 0 to 4	0.67	Standard Error 0.094	minutes
Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation	Pooled GSK557296	Week 0 to 4	0.68	Standard Error 0.071	minutes
Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation	Placebo	Week 4 to 8	0.65	Standard Error 0.110	minutes
Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation	GSK557296 50 mg	Week 4 to 8	0.86	Standard Error 0.168	minutes

1 to 10 of 304Source ClinicalTrials.gov

See all 304 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	27
Overall Study	STARTED	GSK557296 50 mg	22
Overall Study	STARTED	GSK557296 150 mg	28
Overall Study	COMPLETED	Placebo	23
Overall Study	COMPLETED	GSK557296 50 mg	17
Overall Study	COMPLETED	GSK557296 150 mg	25
Overall Study	NOT COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	GSK557296 50 mg	5
Overall Study	NOT COMPLETED	GSK557296 150 mg	3

Source ClinicalTrials.gov

Adverse events57

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	Placebo	3	25
other	Headache	Nervous system disorders	GSK557296 50 mg	3	22
other	Headache	Nervous system disorders	GSK557296 150 mg	5	28
other	Hyperaesthesia	Nervous system disorders	Placebo	0	25
other	Hyperaesthesia	Nervous system disorders	GSK557296 50 mg	0	22
other	Hyperaesthesia	Nervous system disorders	GSK557296 150 mg	1	28
other	Presyncope	Nervous system disorders	Placebo	2	25
other	Presyncope	Nervous system disorders	GSK557296 50 mg	0	22
other	Presyncope	Nervous system disorders	GSK557296 150 mg	0	28
other	Fatigue	General disorders	Placebo	0	25

1 to 10 of 57Source ClinicalTrials.gov

See all 57 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	25
Total, all-cause mortality	GSK557296 50 mg	0	22
Total, all-cause mortality	GSK557296 150 mg	0	28
Total, other adverse events	Placebo	8	25
Total, other adverse events	GSK557296 50 mg	6	22
Total, other adverse events	GSK557296 150 mg	10	28
Total, serious adverse events	Placebo	0	25
Total, serious adverse events	GSK557296 50 mg	0	22
Total, serious adverse events	GSK557296 150 mg	0	28

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23937679	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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