Back to resultsA Study On Concentrations Of 16448 In Blood And The Safety Of This Compound In Healthy Males With Premature Ejaculation
Primary Purpose
Premature Ejaculation
Status
Completed
Phase
Phase 2
Locations
Ireland
Study Type
Interventional
Intervention
16448
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ejaculation focused on measuring Premature ejaculation (PE) ejaculatory latency time (ELT)
Eligibility Criteria
Inclusion criteria:
- Body weight >50kg
- Body Mass Index (BMI): 19-30
- Healthy men with long term (at least 6 months) symptoms of PE
- Erectile Dysfunction - (patients should have EF(Erectile Function) domain of IIEF(International Index of Erectile Function questionnaire >26 or normal)
- No history of reduced sexual desire
- No history of significant psychiatric illness or currently active significant medical illness
- No SSRI's(Selective Serotonin Reuptake Inhibitors) use within the last 4 months
- No history of diabetes, renal or hepatic disease
- No significant injuries to the head or spinal cord i.e. history of head injury, spinal cord injuries, and conditions such as multiple sclerosis.
Exclusion criteria:
- Previous or current use of any PDE-5(Phosphodiesterase type 5) inhibitors for the treatment of Erectile Dysfunction
- Subject receiving treatment in the last 6 months for depression, psychiatric disorders, mood disorders, schizophrenia, substance abuse or anxiety disorders
- Subject is taking tricyclic anti-depressants, selective serotonin reuptake inhibitors (or related drugs), mono-amine oxidase inhibitors or ß-blockers
- Subject has received or is continuing to receive any treatment for PE (e.g. local anaesthetic spray, or intra-cavernosal injection) in the four weeks prior to the study start
- Subject has a history of other clinically significant organic diseases e.g. uncontrolled hypertension, ischemic heart
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
-vital signs, ECGs, clinical laboratory tests, adverse events at 24h -area under plasma drug concentration versus time curve [AUC (0-t),AUC (0-8)], maximum observed plasma concentration (Cmax),time at max concentration(Tmax)& half life (T1/2)
Secondary Outcome Measures
Measurement of ELT following a single dose of 16448 compared to placebo at approximately 1-2h, post-dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00537459
Brief Title
A Study On Concentrations Of 16448 In Blood And The Safety Of This Compound In Healthy Males With Premature Ejaculation
Official Title
A Randomized, Double-blind, Placebo-controlled, Two-session Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an 16448 in Healthy Males With Premature Ejaculation.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
16448 is being investigated for the treatment of primary premature ejaculation (PE) using a novel mode of action. There are no approved therapies for premature ejaculation, and novel therapies are needed for this syndrome.
16448 has been shown to increase ejaculatory latency in the PCA rat model of premature ejaculation.
A novel instrument, the Sexual Assessment Monitor (SAM), will be used to measure ejaculatory latency time in this study. This device, which measures ELT under standard conditions, has been shown to provide a more reliable measure of ejaculatory latency compared to the use of a stopwatch during sexual intercourse
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
Keywords
Premature ejaculation (PE) ejaculatory latency time (ELT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
16448
Primary Outcome Measure Information:
Title
-vital signs, ECGs, clinical laboratory tests, adverse events at 24h -area under plasma drug concentration versus time curve [AUC (0-t),AUC (0-8)], maximum observed plasma concentration (Cmax),time at max concentration(Tmax)& half life (T1/2)
Time Frame
24h
Secondary Outcome Measure Information:
Title
Measurement of ELT following a single dose of 16448 compared to placebo at approximately 1-2h, post-dose
Time Frame
1-2h, post-dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Body weight >50kg
Body Mass Index (BMI): 19-30
Healthy men with long term (at least 6 months) symptoms of PE
Erectile Dysfunction - (patients should have EF(Erectile Function) domain of IIEF(International Index of Erectile Function questionnaire >26 or normal)
No history of reduced sexual desire
No history of significant psychiatric illness or currently active significant medical illness
No SSRI's(Selective Serotonin Reuptake Inhibitors) use within the last 4 months
No history of diabetes, renal or hepatic disease
No significant injuries to the head or spinal cord i.e. history of head injury, spinal cord injuries, and conditions such as multiple sclerosis.
Exclusion criteria:
Previous or current use of any PDE-5(Phosphodiesterase type 5) inhibitors for the treatment of Erectile Dysfunction
Subject receiving treatment in the last 6 months for depression, psychiatric disorders, mood disorders, schizophrenia, substance abuse or anxiety disorders
Subject is taking tricyclic anti-depressants, selective serotonin reuptake inhibitors (or related drugs), mono-amine oxidase inhibitors or ß-blockers
Subject has received or is continuing to receive any treatment for PE (e.g. local anaesthetic spray, or intra-cavernosal injection) in the four weeks prior to the study start
Subject has a history of other clinically significant organic diseases e.g. uncontrolled hypertension, ischemic heart
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Belfast
ZIP/Postal Code
BT9 6AD
Country
Ireland
12. IPD Sharing Statement
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A Study On Concentrations Of 16448 In Blood And The Safety Of This Compound In Healthy Males With Premature Ejaculation
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