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Trial record 2 of 2 for:    "Premature Ejaculation" | "Norflurane"

Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation

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ClinicalTrials.gov Identifier: NCT00556478
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : September 26, 2016
Last Update Posted : September 26, 2016
Sponsor:
Collaborator:
Shionogi Inc.
Information provided by (Responsible Party):
Plethora Solutions Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Premature Ejaculation
Interventions Drug: PSD502, contains a mixture of lidocaine and prilocaine
Drug: Placebo
Enrollment 256
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Double-Blind Active / Open-Label Active Double-Blind Placebo / Open-Label Active
Hide Arm/Group Description

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.

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.

Period Title: Double-blind Phase
Started 171 85
ITT 167 82
Completed 150 77
Not Completed 21 8
Period Title: Open-Label Phase
Started 146 77
Treated in Open-label 142 71
Completed 132 67
Not Completed 14 10
Arm/Group Title Double-Blind Active / Open-Label Active Double-Blind Placebo / Open-Label Active Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 167 82 249
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 82 participants 249 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
163
  97.6%
81
  98.8%
244
  98.0%
>=65 years
4
   2.4%
1
   1.2%
5
   2.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 167 participants 82 participants 249 participants
39.1  (11.71) 37.9  (11.97) 38.7  (11.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 82 participants 249 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
167
 100.0%
82
 100.0%
249
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 167 participants 82 participants 249 participants
Poland 68 32 100
Canada 14 7 21
United States 85 43 128
1.Primary Outcome
Title Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment
Hide Description

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).

Time Frame Baseline to 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Double-Blind Active / Open-Label Active Double-Blind Placebo / Open-Label Active
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 167 82
Geometric Mean (Full Range)
Unit of Measure: ratio
4.607
(0.01 to 559.78)
1.505
(0.27 to 12.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Active / Open-Label Active, Double-Blind Placebo / Open-Label Active
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio (over 3 months/Baseline)
Estimated Value 3.05
Confidence Interval (2-Sided) 95%
2.29 to 4.06
Estimation Comments [Not Specified]
2.Primary Outcome
Title Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3
Hide Description

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

Time Frame Baseline to 3 Months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Double-Blind Active / Open-Label Active Double-Blind Placebo / Open-Label Active
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 167 82
Mean (Full Range)
Unit of Measure: Score
Ejaculatory control
7.2
(-3 to 16)
2.2
(-1 to 14)
Sexual satisfaction
6.6
(-8 to 16)
2.1
(-4 to 14)
Distress
3.5
(-2 to 8)
0.9
(-2 to 6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-Blind Active / Open-Label Active, Double-Blind Placebo / Open-Label Active
Comments Analysis of IPE domain ejaculatory control
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5
Confidence Interval (2-Sided) 95%
3.61 to 6.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-Blind Active / Open-Label Active, Double-Blind Placebo / Open-Label Active
Comments IPE domain sexual satisfaction
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
3.30 to 5.84
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Double-Blind Active / Open-Label Active, Double-Blind Placebo / Open-Label Active
Comments IPE domain distress
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
1.86 to 3.20
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment
Hide Description 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
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Double-Blind Active / Open-Label Active Double-Blind Placebo / Open-Label Active
Hide Arm/Group Description:

Double-blind Phase: Subjects will be randomised to PSD502 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 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.

Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.

Placebo: 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.

Overall Number of Participants Analyzed 167 82
Measure Type: Number
Unit of Measure: percentage of subjects
IELT > 1 minute 80.2 37.8
IELT > 2 minutes 57.5 14.6
4.Secondary Outcome
Title Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3
Hide Description Summary of mean IELT at Baseline and at month 3 during double-blind treatment
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Double-Blind Active / Open-Label Active Double-Blind Placebo / Open-Label Active
Hide Arm/Group Description:

Double-blind Phase: Subjects will be randomised to PSD502 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 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.

Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.

Placebo: 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.

Overall Number of Participants Analyzed 167 82
Geometric Mean (Standard Deviation)
Unit of Measure: Seconds
140.964  (463.97) 49.615  (91.75)
5.Secondary Outcome
Title Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1
Hide Description

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

Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Double-Blind Active / Open-Label Active Double-Blind Placebo / Open-Label Active
Hide Arm/Group Description:

Double-blind Phase: Subjects will be randomised to PSD502 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 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.

Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.

Placebo: 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.

Overall Number of Participants Analyzed 167 82
Mean (Standard Deviation)
Unit of Measure: Score
Ejaculatory control 5.7  (5.92) 1.3  (2.75)
Distress 2.5  (2.64) 0.6  (1.70)
Sexual satisfaction 5.1  (5.86) 1.8  (3.54)
6.Secondary Outcome
Title Subject PEP at Month 1
Hide Description 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.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Double-Blind Active / Open-Label Active Double-Blind Placebo / Open-Label Active
Hide Arm/Group Description:

Double-blind Phase: Subjects will be randomised to PSD502 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 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.

Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.

Placebo: 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.

Overall Number of Participants Analyzed 167 82
Measure Type: Number
Unit of Measure: percentage of participants
Control 59.6 23.5
Distress 63.4 27.2
Sexual satisfaction 62.7 33.3
Interpersonal difficulty 72.0 51.9
7.Secondary Outcome
Title Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2
Hide Description

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

Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Double-Blind Active / Open-Label Active Double-Blind Placebo / Open-Label Active
Hide Arm/Group Description:

Double-blind Phase: Subjects will be randomised to PSD502 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 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.

Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.

Placebo: 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.

Overall Number of Participants Analyzed 167 82
Mean (Standard Deviation)
Unit of Measure: Score
Control 6.5  (6.06) 1.4  (3.12)
Satisfaction 5.8  (6.19) 1.3  (3.68)
Distress 2.9  (3.00) 0.7  (1.85)
8.Secondary Outcome
Title Subject Premature Ejaculation Profile (PEP) at Month 2
Hide Description 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.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Double-Blind Active / Open-Label Active Double-Blind Placebo / Open-Label Active
Hide Arm/Group Description:

Double-blind Phase: Subjects will be randomised to PSD502 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 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.

Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.

Placebo: 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.

Overall Number of Participants Analyzed 167 82
Measure Type: Number
Unit of Measure: percentage of participants
Control 67.5 24.7
Distress 70.1 33.8
Sexual satisfaction 69.4 27.3
Interpersonal difficulty 75.8 42.9
9.Secondary Outcome
Title Subject Premature Ejaculation Profile (PEP) at Month 3
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Double-Blind Active / Open-Label Active Double-Blind Placebo / Open-Label Active
Hide Arm/Group Description:

Double-blind Phase: Subjects will be randomised to PSD502 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 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.

Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.

Placebo: 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.

Overall Number of Participants Analyzed 167 82
Measure Type: Number
Unit of Measure: percentage of participants
Control 72.4 24.1
Distress 76.9 36.7
Sexual satisfaction 73.7 36.7
Interpersonal difficulty 77.6 59.5
10.Secondary Outcome
Title Partner Premature Ejaculation Profile (PEP) at Month 3
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Double-Blind Active / Open-Label Active Double-Blind Placebo / Open-Label Active
Hide Arm/Group Description:

Double-blind Phase: Subjects will be randomised to PSD502 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 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.

Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.

Placebo: 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.

Overall Number of Participants Analyzed 167 82
Measure Type: Number
Unit of Measure: percentage of partners
Control 68.9 40.8
Distress 64.9 50.0
Sexual satisfaction 62.8 32.9
Interpersonal difficulty 66.9 50.0
Time Frame Treatment emergent Adverse Events collected from randomisation to end of study
Adverse Event Reporting Description Safety Population - all subjects that received the study drug.
 
Arm/Group Title Double-Blind Active Double-Blind Placebo Open Label Phase
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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.

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.

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.

All-Cause Mortality
Double-Blind Active Double-Blind Placebo Open Label Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Double-Blind Active Double-Blind Placebo Open Label Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/167 (0.60%)      1/82 (1.22%)      4/223 (1.79%)    
Cardiac disorders       
Coronary artery disease and myocardial infarction  1  0/167 (0.00%)  0 0/82 (0.00%)  0 1/223 (0.45%)  1
Hepatobiliary disorders       
Cholelithiasis  1  0/167 (0.00%)  0 0/82 (0.00%)  0 1/223 (0.45%)  1
Injury, poisoning and procedural complications       
Burns second degree  1  1/167 (0.60%)  1 0/82 (0.00%)  0 0/223 (0.00%)  0
Contusion  1  0/167 (0.00%)  0 1/82 (1.22%)  1 0/223 (0.00%)  0
Concussion  1  0/167 (0.00%)  0 0/82 (0.00%)  0 1/223 (0.45%)  1
Investigations       
blood albumin, haematocrit, platelet count, protein total, RBC count decreased  1  0/167 (0.00%)  0 0/82 (0.00%)  0 1/223 (0.45%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Double-Blind Active Double-Blind Placebo Open Label Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/167 (5.39%)      0/82 (0.00%)      8/223 (3.59%)    
Reproductive system and breast disorders       
Erectile dysfunction  1  9/167 (5.39%)  14 0/82 (0.00%)  0 8/223 (3.59%)  20
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
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Name/Title: Chief Scientific Officer
Organization: Plethora Solutions
Phone: +44 (0) 20 3077 5400
EMail: mail@plethorasolutions.co.uk
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Responsible Party: Plethora Solutions Ltd
ClinicalTrials.gov Identifier: NCT00556478     History of Changes
Other Study ID Numbers: PSD502-PE-002
First Submitted: November 9, 2007
First Posted: November 12, 2007
Results First Submitted: September 7, 2016
Results First Posted: September 26, 2016
Last Update Posted: September 26, 2016