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.
- Conditions
- Premature ejaculation.MedDRA version: 9.1Level: LLTClassification code 10036596Term: Premature ejaculation
- Registration Number
- EUCTR2009-011855-40-NL
- Lead Sponsor
- GlaxoSmithKline Research and Development Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 75
1.Males with primary PE, according to the ISSM Consensus Definition (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).
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Positive pre-study Hepatitis B surface antigen or Hepatitis C antibody
result and HIV antibody and or confirmatory ELISA test at screening.
- History of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Erectile dysfunction (IIEF-EF domain score < 22)
- Active/recent (< 6 months) prostatitis (symptoms or treatment seeking for newly diagnosed or flare of symptoms related to previously diagnosed prostatitis).
- Any unstable medical, psychiatric or substance abuse disorder.
- Penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s
disease) that 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 (as defined in protocol)
- History of congenital QT prolongation and/or QTc interval >450msec at screening
visit (Visit 1) using the Bazett formula.
- Mean diastolic/systolic cuff BP > 90/140 mmHg at the screening visit.
- 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 used within 7 days of Visit 1 and or at any time
during the study
- 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.
- Abnormal laboratory values:
- Serum total testosterone level >25% below the lower limit of normal according to the range of the testing laboratory (obtained in the morning vs in the afternoon).
- Subjects with a clinically significant elevation of serum creatinine outside the country specific normal reference ranges.
- Clinically significant elevation of AST (of > 126) and/or ALT (of > 144).
- Screening PSA value outside the country specific normal reference ranges
- TSH outside the country specific normal reference ranges at visit 1.
- Free Triiodothyronine [T3] outside the country specific normal reference ranges at visit 1.
- Free Thyroxine T4 outside the country specific normal reference ranges at visit 1.
- Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe
(Child-Pugh C) hepatic impairment.
- Known hypersensitivity to GSK557296 or any component of the
investigational medication.
- Subjects who are illiterate or unable to understand the questionnaires or the subject diary.
- Subjects who are unwilling or unable to complete the subject diary.
- Subjects who are unwilling to be randomized to placebo.
- Subject whose sexual partner is actively trying to conceive, and or is unwilling to use a reliable form of birth control as outlined in Section 8.1 for the duration of the trial. Or whose female partner is breast feeding.
- Subjects, who in the opinion of the investigator,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if an on demand dosing of 50 or 150 mg of GSK557296 demonstrates superior efficacy with respect to duration of IELT during an 8 week study period compared to placebo in men with premature ejaculation.;Secondary Objective: 1. To assess safety and tolerability of 50 mg and 150 mg of GSK557296. <br>2. To assess change in the Index of Premature Ejaculation (IPE) from baseline and at the end of the 8 weeks of treatment<br>3. To characterize the pharmacokinetics of GSK557296 in men with premature ejaculation.<br>4. To characterize the dose/exposure response relationship using PK/PD modeling, as data permit.<br>;Primary end point(s): Intravaginal ejaculatory latency time: Time from vaginal penetration (start stopwatch) until ejaculation (stop stopwatch), assessed after every attempt at intercourse with 50mg, 150 mg GSK557296 or placebo therapy, compared over all 8 weeks of treatment or until premature discontinuation.<br>
- Secondary Outcome Measures
Name Time Method