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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01021553
First Posted: November 30, 2009
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: June 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Premature Ejaculation
Interventions: Drug: GSK557296
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 6 sites in United States and 2 centers in the Netherlands during 23 December 2009 to 05 May 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Placebo   GSK557296 50 mg   GSK557296 150 mg
STARTED   27   22   28 
COMPLETED   23   17   25 
NOT COMPLETED   4   5   3 
Adverse Event                1                0                0 
Lack of Efficacy                2                2                0 
Protocol Violation                0                2                2 
Lost to Follow-up                0                0                1 
Withdrawal by Subject                1                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo 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 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.
Total Total of all reporting groups

Baseline Measures
   Placebo   GSK557296 50 mg   GSK557296 150 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   22   28   77 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.4  (8.90)   37.9  (9.85)   34.0  (9.00)   36.7  (9.31) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      27 100.0%      22 100.0%      28 100.0%      77 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1   3.7%      0   0.0%      2   7.1%      3   3.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      1   3.6%      1   1.3% 
Black or African American      2   7.4%      2   9.1%      3  10.7%      7   9.1% 
White      24  88.9%      20  90.9%      21  75.0%      65  84.4% 
More than one race      0   0.0%      0   0.0%      1   3.6%      1   1.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation   [ Time Frame: Up to Week 8 ]

2.  Secondary:   Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation   [ Time Frame: Up to Week 8 ]

3.  Secondary:   Mean IELT Compared After the First Dose of Study Drug or Placebo   [ Time Frame: Up to Week 8 ]

4.  Secondary:   Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation   [ Time Frame: Baseline and up to Week 8 ]

5.  Secondary:   Mean Change From Baseline in IELT Compared After the First Dose of Study Drug or Placebo   [ Time Frame: Baseline and Week 4 ]

6.  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   [ Time Frame: At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization ]

7.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of GSK557296   [ Time Frame: At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization ]

8.  Secondary:   Time of Occurrence of Maximum Observed Plasma Concentration (Tmax) of GSK557296   [ Time Frame: At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization ]

9.  Secondary:   Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Baseline and up to follow up (post treatment 48 hours) ]

10.  Secondary:   Mean Change From Baseline in Heart Rate   [ Time Frame: Baseline and up to follow up (post treatment 48 hours) ]

11.  Secondary:   Mean Change From Baseline in Electrocardiogram (ECG) Values   [ Time Frame: Baseline and up to follow up (post treatment 48 hours) ]

12.  Secondary:   Number of Participants With Shift From Baseline in Serum Laboratory Values (Clinical Chemistry)   [ Time Frame: Baseline and up to follow up (post treatment 48 hours) ]

13.  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)   [ Time Frame: Baseline and up to follow up (post treatment 48 hours) ]

14.  Secondary:   Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline and up to follow up (post treatment 48 hours) ]

15.  Secondary:   Number of Participants With Dose/Exposure Response Relationship Using PK/Pharmacodynamics (PD) Modeling   [ Time Frame: Up to Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01021553     History of Changes
Other Study ID Numbers: 109059
First Submitted: November 12, 2009
First Posted: November 30, 2009
Results First Submitted: June 20, 2017
Results First Posted: September 12, 2017
Last Update Posted: September 12, 2017