Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patient suffering from premature ejaculation
Trial description: The purpose of this study is to determine if the administration of GSK958108 can delay ejaculation in patients with primary premature ejaculation as measured by the ejaculatory latency time (ELT) using the masturbation model and sexual visual stimulation, and to evaluate the safety and tolerability of GSK958108 in healthy men with PE
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Time to achieve ejaculation from the start of masturbation during audio-video erotic stimuli
Timeframe: 50 minutes
Secondary outcomes:
Safety and tolerability measured as adverse events occurrence, vital signs variations, safety laboratory, eye assessments, ECG and physical examination
Timeframe: 8 weeks
Blood concentration of GSK958108 at different timepoints
Timeframe: From predose to 30 hours post-dose
Interventions:
Drug: GSK958108
Drug: Placebo
Enrollment:
33
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on the ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. ISSM (2013) International Society for Sexual Medicine - International Symposium 2013
Medical condition
Premature Ejaculation
Product
GSK958108
Collaborators
Not applicable
Study date(s)
November 2008 to December 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 50 years
Accepts healthy volunteers
No
- Heterosexual male subject with self-reported moderate or severe primary Premature ejaculation with ejaculation occurring on or before penetration, or shortly there after with minimal stimulation
- Baseline Ejaculation Latency time < 3 minutes
- Erectile dysfunction
- History of migraine
Inclusion and exclusion criteria
Inclusion criteria:
- Heterosexual male subject with self-reported moderate or severe primary Premature ejaculation with ejaculation occurring on or before penetration, or shortly there after with minimal stimulation
- Baseline Ejaculation Latency time < 3 minutes
- Subjects must agree to use a contraception methods as per protocol
- Body weight > or = 50 kg and Body Mass Index within the range 19.0-29.9 Kg/m2
- Subject with normal visual acuity (with appropriate correction if needed)
- Subject able to cooperate in all study procedure including the eye examination with use of mydriatics
Exclusion criteria:
- Erectile dysfunction
- History of migraine
- Current clinically relevant abnormality
- History of psychiatric illness or suicidal attempts or behaviours
- History of any eye disorder or colour blind, excluding myopia and presbyopia
- Cardiac conduction disorder or other clinically significant cardiac disease
- Positive at pre-study drug/alcohol screen and to Hepatitis or HIV tests
- Regular consumption of alcohol
- History of sensitivity or intolerance to drugs
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids] from 7 days prior to the first dose of study medication
- Subject has received or is continuing to receive any treatment for premature ejaculation in the four weeks prior to the study start
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements prior to the first dose of study medication
- Participation in another clinical trial in the previous month
- Exposure to more than four new experimental drugs within the previous 12 months
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-11-12
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.
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