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A Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Study in Men With Premature Ejaculation | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Study in Men With Premature Ejaculation

A Phase II Study to Evaluate: Delay in Intravaginal Ejaculatory Latency Time (IELT), Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Randomized, Double Blind, Placebo-Controlled, Parallel Group Study in Men With Premature Ejaculation

NCT01021553•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an 8 week study period compared to placebo in men with primary premature ejaculation. An assessment of the safety and tolerability of all doses of GSK557296 will be performed as well as an assessment for change in the Index of Premature Ejaculation (IPE) from baseline and at the end of the 8 weeks of treatment. During the active treatment period study participants will be limited to a maximum of 40 doses of GSK557296, or placebo, spilt as 20 doses for both 4 week intervals.

Eligibility

Age

18 - 50 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Males with primary PE, according to the ISSM Consensus Definition. Defined as, a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and, inability to delay ejaculation on all or nearly all vaginal penetrations; and, negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy
•2. Stable heterosexual relationship, with a single non pregnant, nonlactating female partner using adequate contraception (as confirmed by oral questioning of male study subject) in a relationship of greater than \>4 months duration. This same partner will be the one with whom the subject makes and records all IELT attempts during the duration of the study.
•3. Aged between 18 and 50 years (i.e. subjects must not have completed their 50th year birthday at the time of screening, but can turn 50 years during the course of the study).
•4. The subject must make at least four attempts at sexual intercourse on four separate days during the untreated run in period.
•5. The average intravaginal ejaculatory latency time must be \<65 seconds based on the study-provided stop watch assessments

Exclusion Criteria

•1. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result and positive HIV antibody and or confirmatory ELISA test at screening.
•2. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
•Previous or Current Medical Conditions
•1. Erectile dysfunction (defined as IIEF-EF domain score \< 22)
•2. Active or recent (\< 6 months) history of prostatitis, as determined by patient symptoms or treatment seeking for newly diagnosed or flare of symptoms related to previously diagnosed prostatitis.
•3. Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
•4. Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease) that in the opinion of the investigator would significantly impair sexual performance.
•5. Prior implantation of penile implant for erectile dysfunction
•6. Primary hypoactive sexual desire.
•7. Spinal cord injury.
+34 more criteria

Locations (8)

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

San Jose, California, United States

GSK Investigational Site

Fort Wayne, Indiana, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Bala-Cynwyd, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Amsterdam, Netherlands

GSK Investigational Site

Utrecht, Netherlands

Key Dates

Start Date

December 23, 2009

Primary Completion Date

May 5, 2011

Completion Date

May 5, 2011

Last Updated

September 12, 2017

Enrollment

ACTUAL participants

Conditions

Premature Ejaculation

Interventions

GSK557296

DRUG

GSK557296

DRUG

placebo

DRUG

Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)

NCT07434271

Premature Ejaculation

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RECRUITINGNA

Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial

NCT06570135

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NOT_YET_RECRUITINGNA

Hyaluronic Acid vs Botulinum Toxin Injection in Treatment of Lifelong Drug-Resistant Premature Ejaculation: Randomized Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 12, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Study in Men With Premature Ejaculation

Inclusion Criteria

Exclusion Criteria

Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)

Brain Activity During Sexual Behavior in Patients With Primary Premature Ejaculation a Clinical Trial

Hyaluronic Acid vs Botulinum Toxin Injection in Treatment of Lifelong Drug-Resistant Premature Ejaculation: Randomized Study

THE IMPACT OF VITAMIN B12 TREATMENT ON EJACULATORY FUNCTIONS IN MEN: SYMPTOMATIC RELIEF AND IMPROVED OUTCOMES

Primary Premature Ejaculation Genetics

Clinical Study to Reduce Premature Ejaculation in Healthy Adult Men