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A Study On Concentrations Of 16448 In Blood And The Safety Of This Compound In Healthy Males With Premature Ejaculation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00537459
First received: January 25, 2007
Last updated: March 15, 2012
Last verified: February 2011

January 25, 2007
March 15, 2012
December 2006
Not Provided
-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 ]
Same as current
Complete list of historical versions of study NCT00537459 on ClinicalTrials.gov Archive Site
Measurement of ELT following a single dose of 16448 compared to placebo at approximately 1-2h, post-dose [ Time Frame: 1-2h, post-dose ]
Same as current
Not Provided
Not Provided
 
A Study On Concentrations Of 16448 In Blood And The Safety Of This Compound In Healthy Males With Premature Ejaculation
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.

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Premature Ejaculation
Drug: 16448
Other Name: 16448
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
Not Provided
Not Provided

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
Male
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Ireland
 
NCT00537459
OTP108172
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP