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

NCT01021553 | Completed Phase 2 Results

• 1 other identifier: 109059
• Study Type: interventional
• Target: 77
• Locations: 2 countries
• Sites: 8

Brief 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.

Conditions

Premature Ejaculation

Keywords

Proof of Concept; Double Blind

Outcome Measures

Primary Outcomes (1)

• Mean Intravaginal Ejaculatory Latency Time (IELT) Compared Over All 8 Weeks of Treatment or Until Premature Discontinuation

  Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p \< 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).

  Up to Week 8

Secondary Outcomes (14)

• Mean IELT Compared After Each 4-week Treatment Period, or Until Premature Discontinuation

  Up to Week 8

• Mean IELT Compared After the First Dose of Study Drug or Placebo

  Up to Week 8

• Mean Change From Baseline in IELT Compared After Each 4-week Treatment Period and Over All 8 Weeks or Until Premature Discontinuation

  Baseline and up to Week 8

• Mean Change From Baseline in IELT Compared After the First Dose of Study Drug or Placebo

  Baseline and Week 4

• Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time [AUC(0-inf)] and From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] of GSK557296

  At 0, 0.25, 0.5, 0.75, 1, 2, 4, 6 and 8 hours at visit 2 or within 7 days of randomization

Study Arms (3)

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

50 mg

ACTIVE COMPARATOR

50 mg GSK557296

Drug: GSK557296

150 mg

ACTIVE COMPARATOR

150 mg GSK557296

Drug: GSK557296

Interventions

GSK557296 DRUG

50 mg GSK557296

Also known as: 50 mg

50 mg

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

San Diego, California, 92120, United States

Location

GSK Investigational Site

San Jose, California, 95128, United States

Location

GSK Investigational Site

Fort Wayne, Indiana, 46825, United States

Location

GSK Investigational Site

New York, New York, 10016, United States

Location

GSK Investigational Site

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

GSK Investigational Site

Amsterdam, 1081 HV, Netherlands

Location

GSK Investigational Site

Utrecht, 3584 CJ, Netherlands

Location

Related Publications (1)

• Shinghal R, Barnes A, Mahar KM, Stier B, Giancaterino L, Condreay LD, Black L, McCallum SW. Safety and efficacy of epelsiban in the treatment of men with premature ejaculation: a randomized, double-blind, placebo-controlled, fixed-dose study. J Sex Med. 2013 Oct;10(10):2506-17. doi: 10.1111/jsm.12272. Epub 2013 Aug 12.

  PMID: 23937679 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Premature Ejaculation

Interventions

epelsiban; MG 50-3-1

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 30, 2009
• Study Start: December 23, 2009
• Primary Completion: May 5, 2011
• Study Completion: May 5, 2011
• Last Updated: September 12, 2017
• Results First Posted: September 12, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

US (6); NL (2)