Premature EjaculationPhase 2/3NCT00556478
Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation
A Phase 2/3 study testing PSD502, contains a mixture of lidocaine and prilocaine in people with Premature Ejaculation, run by Plethora Solutions Ltd at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness, safety and tolerability of the investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug, PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic (numbing) spray containing a mixture of… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- PSD502, contains a mixture of lidocaine and prilocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2009
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent.
- Male and aged 18 years and over.
- Diagnosed with PE according to DMS-IV criteria and ISSM definition
- Diagnosed with lifelong PE
- Acceptable response to Baseline PEP
- Subject must be in a stable heterosexual and monogamous relationship and the partner must provide consent
- Acceptable sexual encounters in the Baseline period.
Who cannot join
- Subject, or his sexual partner, has received an investigational (non-registered) drug within 30 days of Screening.
- Subject has erectile dysfunction
- The subject, or his sexual partner, has a physical or psychological condition that would prevent them from undertaking the study procedures, including, but not limited to, the following:
- Urological disease
- Ongoing significant psychiatric disorder not controlled by medication.
- Subject has safety testing abnormalities at the Screening Visit
Show all 13Show fewer
- Subjects taking excluded medications or receiving any treatment for PE
- Subject, or his sexual partner, has a current history of alcohol or drug abuse,
- The subject, or his sexual partner, is unlikely to understand or be able to comply with study procedures, for whatever reasons.
- Subject, or his sexual partner, has known drug sensitivity to amide-type local anesthetics.
- Subjects with pregnant partners
- Subject with sexual partners of child-bearing potential and not using appropriate contraception
- Subject, or his sexual partner, has a history of Glucose-6-Phosphate Dehydrogenase (G-6-PD) deficiency or use of medications that would increase susceptibility to methemoglobinemia (e.g. anti-malarial agents).
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Urology, University of North Carolina
Chapel Hill, North Carolina, 27599 - 7254
About this study
Official title: A Phase IIb, Multi-center, Randomized, Double-blind, Placebo-controlled Study, With Open-label Follow on, to Evaluate the Efficacy, Safety and Tolerability of PSD502 in Subjects With Premature Ejaculation (PE)
The purpose of this study is to evaluate the effectiveness, safety and tolerability of the investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug, PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic (numbing) spray containing a mixture of lidocaine and prilocaine. The study drug will be applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an attempt to delay ejaculation.
Read the detailed description
Most studies evaluating treatments PE include intravaginal ejaculatory latency time (IELT) in the definition of PE. It has been estimated that PE affects 30-40% of the male population, but is paradoxically a condition for which they are least likely to seek help.
Men with PE exhibit abnormal autonomic reflex pathways for the ejaculatory process. These include lower vibratory threshold to ejaculation, shorter bulbocavernous latency time and higher bulbocavernous evoked potentials. Reducing the heightened sensitivity of the glans penis with topical anesthetics might therefore be a way of improving IELT, without adversely affecting the sensation of ejaculation.
Although IELT is an objective measure of ejaculatory function it does not address the impact of therapy on patients' well being and confidence in their sexual performance, which are important markers of treatment benefit. Therefore, if IELT is used as a sole efficacy measure it may not fully characterise the treatment benefit to the patient. For this reason, a patient reported outcome (PRO) known as the Index of Premature Ejaculation (IPE) will be used in this study in conjunction with IELT to evaluate efficacy. Thus the combination of the objective measure of ejaculatory latency with the PRO of IPE should be able to provide efficacy data which are representative of clinical benefit to the patient.
The use of lidocaine, prilocaine and EMLA® cream as topical anesthetics is well established. Many years of experience of use in large numbers of patients, as well as comprehensive non-clinical safety testing programs for various formulations of lidocaine and prilocaine exist, to support their safety and tolerability. This information, together with the clinical data from 3 studies with PSD502 (ANAE-059-00, PSD502-PE-001, and PSD502-PE-003), suggest that PSD502 may have beneficial effects in reducing penile sensation and prolonging IELT, and its use is unlikely to be associated with significant clinical safety or tolerability concerns.
The aim of this study is to provide additional placebo-controlled efficacy data to establish the clinical utility of PSD502 in the treatment of PE. In addition, long term open-label efficacy and safety data will be collected, to further support the registration package for PSD502 in the indication of treatment of PE.
- Conditions
- Premature Ejaculation
- Being tested
- PSD502, contains a mixture of lidocaine and prilocaine, Placebo
- Keywords
- Premature Ejaculation, Lidocaine, Prilocaine, EMLA® cream, topical anesthetics
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSD502, contains a mixture of lidocaine and prilocaineDrug
PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period.
PlaceboDrug
The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.
Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.
During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.
During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period.
| Study group | Role | What they receive |
|---|---|---|
| Double-Blind Active | Active comparator | Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria. Receives: Drug: PSD502, contains a mixture of lidocaine and prilocaine |
| Double-Blind Placebo | Placebo comparator | Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria. Receives: Drug: Placebo |
| Open Label Phase | Active comparator | Subjects will all receive PSD502 if they wish to continue in the trial. Receives: Drug: PSD502, contains a mixture of lidocaine and prilocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment
To evaluate efficacy of treatment with PSD502 compared with placebo in subjects with PE as measured by:
- change in mean IELT from baseline to during the 3 month double-blind treatment
Results provide are ratio (over the 3 months/baseline).
Measured: Baseline to 3 Months
Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3
To Evaluate Efficacy of Treatment With PSD502 Compared With Placebo in Subjects With PE as measured by:
- changes in all 3 IPE domains from baseline to month 3
Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress
Measured: Baseline to 3 Months
Secondary outcomes (8)
Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment
Percentage of subjects with mean IELT > 1 minute and >2 minutes during the 3 months of double-blind treatment as measured by the proportion of subjects
Measured: 3 months
Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3
Summary of mean IELT at Baseline and at month 3 during double-blind treatment
Measured: 3 months
Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1
Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 1.
Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress
Measured: 1 month
Subject PEP at Month 1
Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 1. Percentage of subjects with at least a 1 point category improvement in subject PEP domain scores at month 1.
Measured: 1 month
Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2
Change in the IPE domains of ejaculatory control, distress and sexual satisfaction from Baseline to month 2
Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress
Measured: 2 months
Subject Premature Ejaculation Profile (PEP) at Month 2
Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 2. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 2.
Measured: 2 months
Subject Premature Ejaculation Profile (PEP) at Month 3
Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the subject PEP at month 3. Proportion of subjects with at least a 1 point category improvement in subject PEP domain scores from baseline to month 3.
Measured: 3 months
Partner Premature Ejaculation Profile (PEP) at Month 3
Scores for perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse and interpersonal difficulty related to ejaculation based on the partner PEP at month 3. Proportion of partners with at least a 1 point category improvement in partner PEP domain scores from baseline to month 3.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plethora Solutions Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shionogi Inc.
- Responsible party
- Sponsor
- Investigators
- Culley Carson, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556478
- Sponsor's protocol ID
- PSD502-PE-002
- Status last verified
- Sep 2016
- First submitted
- 9 Nov 2007
- Last updated
- 26 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dinsmore WW, Hackett G, Goldmeier D, Waldinger M, Dean J, Wright P, Callander M, Wylie K, Novak C, Keywood C, Heath P, Wyllie M. Topical eutectic mixture for premature ejaculation (TEMPE): a novel aerosol-delivery form of lidocaine-prilocaine for treating premature ejaculation. BJU Int. 2007 Feb;99(2):369-75. doi: 10.1111/j.1464-410X.2006.06583.x. Epub 2006 Nov 24.
PubMed 17129234Morales A, Barada J, Wyllie MG. A review of the current status of topical treatments for premature ejaculation. BJU Int. 2007 Sep;100(3):493-501. doi: 10.1111/j.1464-410X.2007.07051.x. Epub 2007 Jul 3.
PubMed 17608824Henry R, Morales A. Topical lidocaine-prilocaine spray for the treatment of premature ejaculation: a proof of concept study. Int J Impot Res. 2003 Aug;15(4):277-81. doi: 10.1038/sj.ijir.3901011.
PubMed 12934056
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb, Multi-center, Randomized, Double-blind, Placebo-controlled Study, With Open-label Follow on, to Evaluate the Efficacy, Safety and Tolerability of PSD502 in Subjects With Premature Ejaculation (PE)
- ClinicalTrials.gov ID
- NCT00556478
- Acronym / sponsor ID
- PSD502-PE-002
- Conditions
- Premature Ejaculation
- Keywords
- Premature Ejaculation, Lidocaine, Prilocaine, EMLA® cream, topical anesthetics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Plethora Solutions LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shionogi Inc.
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Posted 26 Sep 2016
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 evaluate the effectiveness, safety and tolerability of the investigational drug, PSD502 in subjects with premature ejaculation (PE) The study drug, PSD02, is a metered dose (measured dose), topical (applied to the skin surface) anesthetic (numbing) spray containing a mixture of lidocaine and prilocaine. The study drug will be applied in a spray to the penis prior to intercourse in order to decrease sensitivity in an attempt to delay ejaculation.
Detailed description
Most studies evaluating treatments PE include intravaginal ejaculatory latency time (IELT) in the definition of PE. It has been estimated that PE affects 30-40% of the male population, but is paradoxically a condition for which they are least likely to seek help.
Men with PE exhibit abnormal autonomic reflex pathways for the ejaculatory process. These include lower vibratory threshold to ejaculation, shorter bulbocavernous latency time and higher bulbocavernous evoked potentials. Reducing the heightened sensitivity of the glans penis with topical anesthetics might therefore be a way of improving IELT, without adversely affecting the sensation of ejaculation.
Although IELT is an objective measure of ejaculatory function it does not address the impact of therapy on patients' well being and confidence in their sexual performance, which are important markers of treatment benefit. Therefore, if IELT is used as a sole efficacy measure it may not fully characterise the treatment benefit to the patient. For this reason, a patient reported outcome (PRO) known as the Index of Premature Ejaculation (IPE) will be used in this study in conjunction with IELT to evaluate efficacy. Thus the combination of the objective measure of ejaculatory latency with the PRO of IPE should be able to provide efficacy data which are representative of clinical benefit to the patient.
The use of lidocaine, prilocaine and EMLA® cream as topical anesthetics is well established. Many years of experience of use in large numbers of patients, as well as comprehensive non-clinical safety testing programs for various formulations of lidocaine and prilocaine exist, to support their safety and tolerability. This information, together with the clinical data from 3 studies with PSD502 (ANAE-059-00, PSD502-PE-001, and PSD502-PE-003), suggest that PSD502 may have beneficial effects in reducing penile sensation and prolonging IELT, and its use is unlikely to be associated with significant clinical safety or tolerability concerns.
The aim of this study is to provide additional placebo-controlled efficacy data to establish the clinical utility of PSD502 in the treatment of PE. In addition, long term open-label efficacy and safety data will be collected, to further support the registration package for PSD502 in the indication of treatment of PE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Double-Blind Active | Active comparator | Drug: PSD502, contains a mixture of lidocaine and prilocaineDouble-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria. |
| Double-Blind Placebo | Placebo comparator | Drug: PlaceboDouble-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria. |
| Open Label Phase | Active comparator | Drug: PSD502, contains a mixture of lidocaine and prilocaineSubjects will all receive PSD502 if they wish to continue in the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to provide written informed consent.
- Male and aged 18 years and over.
- Diagnosed with PE according to DMS-IV criteria and ISSM definition
- Diagnosed with lifelong PE
- Acceptable response to Baseline PEP
Key exclusion criteria (13 listed)
- Subject, or his sexual partner, has received an investigational (non-registered) drug within 30 days of Screening.
- Subject has erectile dysfunction
- The subject, or his sexual partner, has a physical or psychological condition that would prevent them from undertaking the study procedures, including, but not limited to, the following:
- Subject has safety testing abnormalities at the Screening Visit
- Subjects taking excluded medications or receiving any treatment for PE
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 |
|---|---|---|
| PSD502, contains a mixture of lidocaine and prilocainePSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis. Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue. During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period. | Drug | Double-Blind Active, Open Label Phase |
| PlaceboThe placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine. Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue. During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing. During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period. | Drug | Double-Blind Placebo |
Primary outcome
Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment
Time frame: Baseline to 3 Months
To evaluate efficacy of treatment with PSD502 compared with placebo in subjects with PE as measured by: • change in mean IELT from baseline to during the 3 month double-blind treatment Results provide are ratio (over the 3 months/baseline).
Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3
Time frame: Baseline to 3 Months
To Evaluate Efficacy of Treatment With PSD502 Compared With Placebo in Subjects With PE as measured by: • changes in all 3 IPE domains from baseline to month 3 Ejaculatory control scores range from 4 to 20 with a higher score indicating greater ejaculatory control Sexual satisfaction scores range from 4 to 20 with a higher score indicating greater sexual satisfaction Distress scores range from 2 to 10 with a higher score indicating less distress
8 secondary outcomes
Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment
Time frame: 3 months
Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3
Time frame: 3 months
Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1
Time frame: 1 month
Subject PEP at Month 1
Time frame: 1 month
Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2
Time frame: 2 months
Subject Premature Ejaculation Profile (PEP) at Month 2
Time frame: 2 months
Subject Premature Ejaculation Profile (PEP) at Month 3
Time frame: 3 months
Partner Premature Ejaculation Profile (PEP) at Month 3
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17129234Dinsmore WW, Hackett G, Goldmeier D, Waldinger M, Dean J, Wright P, Callander M, Wylie K, Novak C, Keywood C, Heath P, Wyllie M. Topical eutectic mixture for premature ejaculation (TEMPE): a novel aerosol-delivery form of lidocaine-prilocaine for treating premature ejaculation. BJU Int. 2007 Feb;99(2):369-75. doi: 10.1111/j.1464-410X.2006.06583.x. Epub 2006 Nov 24.
- Background: PubMed 17608824Morales A, Barada J, Wyllie MG. A review of the current status of topical treatments for premature ejaculation. BJU Int. 2007 Sep;100(3):493-501. doi: 10.1111/j.1464-410X.2007.07051.x. Epub 2007 Jul 3.
- Background: PubMed 12934056Henry R, Morales A. Topical lidocaine-prilocaine spray for the treatment of premature ejaculation: a proof of concept study. Int J Impot Res. 2003 Aug;15(4):277-81. doi: 10.1038/sj.ijir.3901011.
- Individual participant dataSharing planned: No
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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.
Culley Carson, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PSD502, contains a mixture of lidocaine and prilocaine in people with Premature Ejaculation, run by Plethora Solutions Ltd at 1 site in United States.
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 7 inclusion and 13 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 26 Sep 2016. 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 United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment (time frame: Baseline to 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00556478, which also lists 3 linked publications.
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 26 Sep 2016.