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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Premature Ejaculation

Treatments

Drug: 16448

Study type

Interventional

Funder types

Industry

Identifiers

NCT00537459

OTP108172

Details and patient eligibility

About

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

Enrollment

18 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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