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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00537459

Purpose

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

Condition	Intervention	Phase
Premature Ejaculation	Drug: 16448	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacokinetics/Dynamics Study
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.

Further study details as provided by GlaxoSmithKline:

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) [ Time Frame: 24h ]

Secondary Outcome Measures:

Measurement of ELT following a single dose of 16448 compared to placebo at approximately 1-2h, post-dose [ Time Frame: 1-2h, post-dose ]

Enrollment:	18
Study Start Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537459

Locations

Ireland
GSK Investigational Site
Belfast, Ireland, BT9 6AD

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	OTP108172
Study First Received:	January 25, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00537459 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

Premature ejaculation (PE) ejaculatory latency time (ELT)

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Mental Disorders
Healthy

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Mental Disorders
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on May 06, 2009