Last updated: 11/04/2018 10:08:26

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

GSK study ID
OTP108172
See study documents
Clinicaltrials.gov ID
NCT00537459
EudraCT ID
2006-004951-39
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomized, double-blind, placebo-controlled, two-session study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of an 16448 in healthy males with premature ejaculation.
Trial description: 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
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

-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)

Timeframe: 24h

Secondary outcomes:

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

Timeframe: 1-2h, post-dose

Interventions:
  • Drug: 16448
    • Enrollment:
    18
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Premature Ejaculation
    Product
    retosiban
    Collaborators
    Not applicable
    Study date(s)
    December 2006 to June 2007
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Body weight >50kg
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • 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. Exclusion criteria:
    • 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    BELFAST, Ireland, BT9 6AD
    Status
    Recruiting
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-06-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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