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

NCT00537459 | Completed Phase 2

• 1 other identifier: OTP108172
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

Premature ejaculation (PE) ejaculatory latency time (ELT)

Outcome Measures

Primary Outcomes (1)

• -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)

  24h

Secondary Outcomes (1)

• Measurement of ELT following a single dose of 16448 compared to placebo at approximately 1-2h, post-dose

  1-2h, post-dose

Interventions

16448 DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Belfast, BT9 6AD, Ireland

Location

MeSH Terms

Conditions

Premature Ejaculation

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: October 1, 2007
• Study Start: December 1, 2006
• Last Updated: March 19, 2012

Record last verified: 2011-02

Locations

IE (1)