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

NCT ID: NCT00537459

Last Updated: 2012-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31

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

Conditions

Premature Ejaculation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

16448

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Belfast, , Ireland

Countries

Ireland

Other Identifiers

OTP108172

Identifier Type: -

Identifier Source: org_study_id