Premature EjaculationPhase 1PoMNCT00861484
Proof of Mechanism in ELT
A Phase 1 study testing GSK958108 in people with Premature Ejaculation, run by GlaxoSmithKline at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- GSK958108
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 26 Nov 2008to 11 Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Premature Ejaculation
- Being tested
- GSK958108, Placebo
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK958108Drug
Coated Tablets 1 mg
PlaceboDrug
Coated tablets
| Study group | Role | What they receive |
|---|---|---|
| GSK958108 3 mg | Experimental | Experimental Receives: Drug: GSK958108 |
| Placebo of GSK958108 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to achieve ejaculation from the start of masturbation during audio-video erotic stimuli
Measured: 50 minutes
Secondary outcomes (2)
Safety and tolerability measured as adverse events occurrence, vital signs variations, safety laboratory, eye assessments, ECG and physical examination
Measured: 8 weeks
Blood concentration of GSK958108 at different timepoints
Measured: From predose to 30 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study start26 Nov 2008
- Primary completion11 Dec 2009
- Study completion11 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861484
- Sponsor's protocol ID
- 111155
- Acronym
- PoM
- Status last verified
- Jun 2017
- First submitted
- 12 Mar 2009
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00861484
- Acronym / sponsor ID
- PoM / 111155
- Conditions
- Premature Ejaculation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2008 (actual)
- Primary completion
- 11 Dec 2009 (actual)
- Study completion
- 11 Dec 2009 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSK958108 3 mg | Experimental | Drug: GSK958108Experimental |
| Placebo of GSK958108 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK958108Coated Tablets 1 mg | Drug | GSK958108 3 mg |
| PlaceboCoated tablets | Drug | Placebo of GSK958108 |
Primary outcome
Time to achieve ejaculation from the start of masturbation during audio-video erotic stimuli
Time frame: 50 minutes
2 secondary outcomes
Safety and tolerability measured as adverse events occurrence, vital signs variations, safety laboratory, eye assessments, ECG and physical examination
Time frame: 8 weeks
Blood concentration of GSK958108 at different timepoints
Time frame: From predose to 30 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 111155 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK958108 in people with Premature Ejaculation, run by GlaxoSmithKline at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to achieve ejaculation from the start of masturbation during audio-video erotic stimuli (time frame: 50 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.