Trial Outcomes & Findings for Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation (NCT NCT00556478)
NCT ID: NCT00556478
Last Updated: 2016-09-26
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
256 participants
Primary outcome timeframe
Baseline to 3 Months
Results posted on
2016-09-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Double-blind Phase
STARTED
|
171
|
85
|
|
Double-blind Phase
ITT
|
167
|
82
|
|
Double-blind Phase
COMPLETED
|
150
|
77
|
|
Double-blind Phase
NOT COMPLETED
|
21
|
8
|
|
Open-Label Phase
STARTED
|
146
|
77
|
|
Open-Label Phase
Treated in Open-label
|
142
|
71
|
|
Open-Label Phase
COMPLETED
|
132
|
67
|
|
Open-Label Phase
NOT COMPLETED
|
14
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation
Baseline characteristics by cohort
| Measure |
Double-Blind Active / Open-Label Active
n=167 Participants
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 Placebo / Open-Label Active
n=82 Participants
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
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
163 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
244 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 11.71 • n=99 Participants
|
37.9 years
STANDARD_DEVIATION 11.97 • n=107 Participants
|
38.7 years
STANDARD_DEVIATION 11.78 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=99 Participants
|
82 Participants
n=107 Participants
|
249 Participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
68 participants
n=99 Participants
|
32 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
14 participants
n=99 Participants
|
7 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=99 Participants
|
43 participants
n=107 Participants
|
128 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 MonthsPopulation: ITT
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).
Outcome measures
| Measure |
Double-Blind Active / Open-Label Active
n=167 Participants
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 Placebo / Open-Label Active
n=82 Participants
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.
|
|---|---|---|
|
Mean Intravaginal Ejaculatory Latency Time (IELT): Change From Baseline to During 3 Month Double Blind-treatment
|
4.607 ratio
Interval 0.01 to 559.78
|
1.505 ratio
Interval 0.27 to 12.58
|
PRIMARY outcome
Timeframe: Baseline to 3 MonthsPopulation: ITT
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
Outcome measures
| Measure |
Double-Blind Active / Open-Label Active
n=167 Participants
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 Placebo / Open-Label Active
n=82 Participants
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.
|
|---|---|---|
|
Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3
Ejaculatory control
|
7.2 Score
Interval -3.0 to 16.0
|
2.2 Score
Interval -1.0 to 14.0
|
|
Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3
Sexual satisfaction
|
6.6 Score
Interval -8.0 to 16.0
|
2.1 Score
Interval -4.0 to 14.0
|
|
Index of Premature Ejaculation (IPE): Change From Baseline to End of Month 3
Distress
|
3.5 Score
Interval -2.0 to 8.0
|
0.9 Score
Interval -2.0 to 6.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: ITT
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
Outcome measures
| Measure |
Double-Blind Active / Open-Label Active
n=167 Participants
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 Placebo / Open-Label Active
n=82 Participants
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.
|
|---|---|---|
|
Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment
IELT > 1 minute
|
80.2 percentage of subjects
|
37.8 percentage of subjects
|
|
Percentage of Subjects With Mean Intravaginal Ejaculatory Latency Time (IELT) > 1 Minute and >2 Minutes During the 3 Months of Double-blind Treatment
IELT > 2 minutes
|
57.5 percentage of subjects
|
14.6 percentage of subjects
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: ITT
Summary of mean IELT at Baseline and at month 3 during double-blind treatment
Outcome measures
| Measure |
Double-Blind Active / Open-Label Active
n=167 Participants
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 Placebo / Open-Label Active
n=82 Participants
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.
|
|---|---|---|
|
Change in Mean Intravaginal Ejaculatory Latency Time (IELT) From Baseline to Month 3
|
140.964 Seconds
Standard Deviation 463.97
|
49.615 Seconds
Standard Deviation 91.75
|
SECONDARY outcome
Timeframe: 1 monthPopulation: ITT
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
Outcome measures
| Measure |
Double-Blind Active / Open-Label Active
n=167 Participants
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 Placebo / Open-Label Active
n=82 Participants
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.
|
|---|---|---|
|
Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1
Sexual satisfaction
|
5.1 Score
Standard Deviation 5.86
|
1.8 Score
Standard Deviation 3.54
|
|
Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1
Ejaculatory control
|
5.7 Score
Standard Deviation 5.92
|
1.3 Score
Standard Deviation 2.75
|
|
Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 1
Distress
|
2.5 Score
Standard Deviation 2.64
|
0.6 Score
Standard Deviation 1.70
|
SECONDARY outcome
Timeframe: 1 monthPopulation: ITT
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.
Outcome measures
| Measure |
Double-Blind Active / Open-Label Active
n=167 Participants
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 Placebo / Open-Label Active
n=82 Participants
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.
|
|---|---|---|
|
Subject PEP at Month 1
Control
|
59.6 percentage of participants
|
23.5 percentage of participants
|
|
Subject PEP at Month 1
Distress
|
63.4 percentage of participants
|
27.2 percentage of participants
|
|
Subject PEP at Month 1
Sexual satisfaction
|
62.7 percentage of participants
|
33.3 percentage of participants
|
|
Subject PEP at Month 1
Interpersonal difficulty
|
72.0 percentage of participants
|
51.9 percentage of participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: ITT
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
Outcome measures
| Measure |
Double-Blind Active / Open-Label Active
n=167 Participants
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 Placebo / Open-Label Active
n=82 Participants
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.
|
|---|---|---|
|
Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2
Control
|
6.5 Score
Standard Deviation 6.06
|
1.4 Score
Standard Deviation 3.12
|
|
Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2
Satisfaction
|
5.8 Score
Standard Deviation 6.19
|
1.3 Score
Standard Deviation 3.68
|
|
Change in the Index of Premature Ejaculation (IPE) Domains of Ejaculatory Control, Distress and Sexual Satisfaction From Baseline to Month 2
Distress
|
2.9 Score
Standard Deviation 3.00
|
0.7 Score
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: ITT
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.
Outcome measures
| Measure |
Double-Blind Active / Open-Label Active
n=167 Participants
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 Placebo / Open-Label Active
n=82 Participants
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.
|
|---|---|---|
|
Subject Premature Ejaculation Profile (PEP) at Month 2
Control
|
67.5 percentage of participants
|
24.7 percentage of participants
|
|
Subject Premature Ejaculation Profile (PEP) at Month 2
Distress
|
70.1 percentage of participants
|
33.8 percentage of participants
|
|
Subject Premature Ejaculation Profile (PEP) at Month 2
Sexual satisfaction
|
69.4 percentage of participants
|
27.3 percentage of participants
|
|
Subject Premature Ejaculation Profile (PEP) at Month 2
Interpersonal difficulty
|
75.8 percentage of participants
|
42.9 percentage of participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: ITT
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.
Outcome measures
| Measure |
Double-Blind Active / Open-Label Active
n=167 Participants
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 Placebo / Open-Label Active
n=82 Participants
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.
|
|---|---|---|
|
Subject Premature Ejaculation Profile (PEP) at Month 3
Control
|
72.4 percentage of participants
|
24.1 percentage of participants
|
|
Subject Premature Ejaculation Profile (PEP) at Month 3
Distress
|
76.9 percentage of participants
|
36.7 percentage of participants
|
|
Subject Premature Ejaculation Profile (PEP) at Month 3
Sexual satisfaction
|
73.7 percentage of participants
|
36.7 percentage of participants
|
|
Subject Premature Ejaculation Profile (PEP) at Month 3
Interpersonal difficulty
|
77.6 percentage of participants
|
59.5 percentage of participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: ITT
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.
Outcome measures
| Measure |
Double-Blind Active / Open-Label Active
n=167 Participants
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 Placebo / Open-Label Active
n=82 Participants
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.
|
|---|---|---|
|
Partner Premature Ejaculation Profile (PEP) at Month 3
Control
|
68.9 percentage of partners
|
40.8 percentage of partners
|
|
Partner Premature Ejaculation Profile (PEP) at Month 3
Distress
|
64.9 percentage of partners
|
50.0 percentage of partners
|
|
Partner Premature Ejaculation Profile (PEP) at Month 3
Sexual satisfaction
|
62.8 percentage of partners
|
32.9 percentage of partners
|
|
Partner Premature Ejaculation Profile (PEP) at Month 3
Interpersonal difficulty
|
66.9 percentage of partners
|
50.0 percentage of partners
|
Adverse Events
Double-Blind Active
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Double-Blind Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Open Label Phase
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind Active
n=167 participants at risk
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 Placebo
n=82 participants at risk
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.
|
Open Label Phase
n=223 participants at risk
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.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.60%
1/167 • Number of events 1 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
0.00%
0/82 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
0.00%
0/223 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/167 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
1.2%
1/82 • Number of events 1 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
0.00%
0/223 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/167 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
0.00%
0/82 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
0.45%
1/223 • Number of events 1 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/167 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
0.00%
0/82 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
0.45%
1/223 • Number of events 1 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
|
Cardiac disorders
Coronary artery disease and myocardial infarction
|
0.00%
0/167 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
0.00%
0/82 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
0.45%
1/223 • Number of events 1 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
|
Investigations
blood albumin, haematocrit, platelet count, protein total, RBC count decreased
|
0.00%
0/167 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
0.00%
0/82 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
0.45%
1/223 • Number of events 1 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
Other adverse events
| Measure |
Double-Blind Active
n=167 participants at risk
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 Placebo
n=82 participants at risk
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.
|
Open Label Phase
n=223 participants at risk
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.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Erectile dysfunction
|
5.4%
9/167 • Number of events 14 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
0.00%
0/82 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
3.6%
8/223 • Number of events 20 • Treatment emergent Adverse Events collected from randomisation to end of study
Safety Population - all subjects that received the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER