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

Completed · Phase 2 · Has a placebo group

Conditions studied: Premature Ejaculation

In brief

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.

Key facts

Study ID

NCT01021553

Run by

GlaxoSmithKline

People needed

77

Starts

2009-12-23

Expected to finish

2011-05-05

Last updated by the study team

2017-09-12

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.
• 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).
• The subject must make at least four attempts at sexual intercourse on four separate days during the untreated run in period.
• The average intravaginal ejaculatory latency time must be <65 seconds based on the study-provided stop watch assessments

You may not qualify if…

• 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.
• 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
• Erectile dysfunction (defined as IIEF-EF domain score < 22)
• 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.
• 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.
• 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.
• Prior implantation of penile implant for erectile dysfunction
• Primary hypoactive sexual desire.
• Spinal cord injury.
• History of seizures, within last 6 months.
• History of prostate cancer treated or untreated.
• History of prostatectomy or prostate procedures for any cause.
• Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia.
• Significant active peptic ulceration.
• Presence of the following conditions prior to screening: myocardial infarction, coronary bypass surgery, coronary artery angioplasty, unstable angina, clinically evident congestive heart failure, cardiac pacemaker, or cerebrovascular accident.
• Cardiac arrhythmia: significant cardiac arrhythmia shown on screening ECG, or a known or suspected history of significant cardiac arrhythmias within six months prior to screening. i.e., pre-existing syndromes, sinus pause > 3 seconds, non-sustained ventricular tachycardia (3 consecutive ectopic beats), sustained ventricular tachycardia (30 consecutive ectopic beats), sustained supraventricular tachycardia (30 consecutive ectopic beats), accessory pathway tachycardia, bradycardia (heart rate < 50 beats per minute), atrial flutter, atrial fibrillation, ectopic pacemaker, sick sinus syndrome, ventricular block (second or third degree), or bundle branch block. Uncontrolled atrial fibrillation/flutter (ventricular response rate less than or equal to 100 bpm) at the screening visit (Visit 1).
• History of congenital QT prolongation and/or QTc interval >450msec at screening visit (Visit 1) using the Bazett formula.
• Mean systolic cuff BP > 140 mmHg, as assessed by three measurements taken in sequence within 5-10ming of last measure. Taken with the study subject in a supine position at the screening visit (Visit 1).
• Mean diastolic cuff BP >90 mmHg, as assess by three measurements taken in sequence within 5-10 minutes of the last measure. Taken with the study subject in a supine position at the screening visit (Visit 1).
• History of malignancy within the past five years (other than squamous or basal cell skin cancer).
• Any condition which would preclude sexual activity.
• Concomitant Medications
• No concomitant medications maybe used within 7 days of Visit 1 and or at any time during the study including oral medications, vacuum devices, constrictive devices, injections, urethral suppositories, gels, any over-the-counter herbal or non-prescription medications, and products purchased via the internet or mail order pharmacies. During the course of the study concomitant medication use can be considered upon consultation and prior agreement with primary investigator and medical monitor. Specific exceptions for asthmatic patients and patients with allergic rhinitis, who are on stable doses of inhaled or intra nasal agents as prescribed by their health care providers, and who have had no adjustments in their prescribed and or actual use within the last 60 days. Agents which are known or expected to have significant systemic exposures as a result of inhaled or intra-nasal use or to have known CYP3A4 drug-drug interaction potential are not included in this exemption.
• Subjects who have received any investigational drug (including placebo) within 30 days of the screening visit or 5 half lives of the investigational drug whichever is longer (Visit 1).

Where it is running

• 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

Full record on ClinicalTrials.gov

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