Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00549211
Other study ID # OTB109039
Secondary ID
Status Completed
Phase Phase 1
First received October 23, 2007
Last updated March 15, 2012
Start date October 2007

Study information

Verified date February 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy males who are 18 to 45 years of age

- Body mass index between 19 and 30 with a body weight greater than 110 pounds and deemed healthy by a physician

- Non-smokers

Exclusion Criteria:

- Alcohol consumption averaging more than 7 drinks per week

- Positive for Hepatitis C antibody, Hepatitis B antigen or HIV

- Any use of prescription drugs or non prescription drugs

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment


Intervention

Drug:
GSK557296


Locations

Country Name City State
United States GSK Investigational Site Evansville Indiana

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety tests up to 24 hrs after dose 12-lead ECG to look at the heart prior to dose and up to 24 hours after Dual-lead telemetry to monitor the heart rhythms for 20 hours prior to dosing and up to 12 hours after dosing Periodic vital signs 24 Hours
Secondary Blood tests to study how long the drug stays in your blood 24 Hours
See also
  Status Clinical Trial Phase
Completed NCT02232425 - IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE) Phase 2
Completed NCT01439984 - Trial of PED-1 in Male Patients With Premature Ejaculation Phase 3
Completed NCT01203202 - Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation Phase 2
Completed NCT01184105 - A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation Phase 1
Completed NCT03942367 - Evaluation of the Safety and Effectiveness of the vPatch Device N/A
Recruiting NCT06425211 - Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation. N/A
Completed NCT02939495 - The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy Phase 4
Completed NCT02572037 - Research and Clinical Value of New Classification for Premature Ejaculation: Multi-Center Research
Recruiting NCT02581826 - Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation Phase 2
Terminated NCT00983736 - Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation Phase 3
Completed NCT00556478 - Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation Phase 2/Phase 3
Not yet recruiting NCT05556083 - Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE) Phase 2
Completed NCT03304808 - Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0 N/A
Completed NCT00861484 - Proof of Mechanism in ELT Phase 1
Completed NCT02984592 - Effect of Exercise on Premature Ejaculation N/A
Recruiting NCT02571101 - A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation Phase 2
Completed NCT03174470 - Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle N/A
Completed NCT02794454 - A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health N/A
Completed NCT02297152 - A New Treatment for Premature Ejaculation? N/A
Not yet recruiting NCT00656552 - Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation Phase 0