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| Name | Class |
|---|---|
| Shionogi Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-Blind Active | Active Comparator | Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria. |
|
| Double-Blind Placebo | Placebo Comparator | Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria. |
|
| Open Label Phase | Active Comparator | Subjects will all receive PSD502 if they wish to continue in the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSD502, contains a mixture of lidocaine and prilocaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 | Baseline to 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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
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).
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| Name | Affiliation | Role |
|---|---|---|
| Culley Carson, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, University of North Carolina | Chapel Hill | North Carolina | 27599 - 7254 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17129234 | Background | 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. | |
| 17608824 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-Blind Active / Open-Label Active | Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria. PSD502, contains a mixture of lidocaine and prilocaine: 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 (PSD502 or Placebo) 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. |
| FG001 | Double-Blind Placebo / Open-Label Active | Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria. PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine. Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Phase |
| ||||||||||||||||
| Open-Label Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-Blind Active / Open-Label Active | Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria. PSD502, contains a mixture of lidocaine and prilocaine: 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 (PSD502 or Placebo) 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | ITT | Posted | Geometric Mean | Full Range | ratio | Baseline to 3 Months |
|
Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double-Blind Active | Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria. PSD502, contains a mixture of lidocaine and prilocaine: 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 (PSD502 or Placebo) 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientific Officer | Plethora Solutions | +44 (0) 20 3077 5400 | mail@plethorasolutions.co.uk |
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| ID | Term |
|---|---|
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| D011318 | Prilocaine |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 |
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|
| Placebo | Drug | 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. |
|
| 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 |
| 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 | 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. | 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 | 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. | 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. | 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. | 3 months |
| Morales 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. |
| 12934056 | Background | Henry 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | Double-Blind Placebo / Open-Label Active | Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria. PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine. Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Double-Blind Placebo / Open-Label Active | Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria. PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine. Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) 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. |
|
|
|
| Primary | 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 | ITT | Posted | Mean | Full Range | Score | Baseline to 3 Months |
|
|
|
|
| Secondary | 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 | ITT | Posted | Number | percentage of subjects | 3 months |
|
|
|
| Secondary | 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 | ITT | Posted | Geometric Mean | Standard Deviation | Seconds | 3 months |
|
|
|
| Secondary | 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 | ITT | Posted | Mean | Standard Deviation | Score | 1 month |
|
|
|
| Secondary | 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. | ITT | Posted | Number | percentage of participants | 1 month |
|
|
|
| Secondary | 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 | ITT | Posted | Mean | Standard Deviation | Score | 2 months |
|
|
|
| Secondary | 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. | ITT | Posted | Number | percentage of participants | 2 months |
|
|
|
| Secondary | 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. | ITT | Posted | Number | percentage of participants | 3 months |
|
|
|
| Secondary | 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. | ITT | Posted | Number | percentage of partners | 3 months |
|
|
|
| 1 |
| 167 |
| 9 |
| 167 |
| EG001 | Double-Blind Placebo | Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria. PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine. Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) 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. | 1 | 82 | 0 | 82 |
| EG002 | Open Label Phase | Subjects will all receive PSD502 if they wish to continue in the trial. PSD502, contains a mixture of lidocaine and prilocaine: 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 (PSD502 or Placebo) 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. | 4 | 223 | 8 | 223 |
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
|
| Coronary artery disease and myocardial infarction | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
|
| blood albumin, haematocrit, platelet count, protein total, RBC count decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
Details of the Study and his/her results shall not be publicized or published in any form to cooperative publication without prior, written consent of Pharm-Olam or the Sponsor. Such approval is necessary to prevent premature disclosure of trade secrets and other confidential information.
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| Distress |
|
| <0.0001 |
| Mean Difference (Final Values) |
| 4.6 |
| 2-Sided |
| 95 |
| 3.30 |
| 5.84 |
| No |
| Superiority or Other |
| IPE domain distress | ANCOVA | <0.0001 | Mean Difference (Final Values) | 2.5 | 2-Sided | 95 | 1.86 | 3.20 | No | Superiority or Other |
| Sexual satisfaction |
|
| Sexual satisfaction |
|
| Interpersonal difficulty |
|
| Distress |
|
| Sexual satisfaction |
|
| Interpersonal difficulty |
|
| Sexual satisfaction |
|
| Interpersonal difficulty |
|
| Sexual satisfaction |
|
| Interpersonal difficulty |
|