Trial Outcomes & Findings for Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED) (NCT NCT02495467)

NCT ID: NCT02495467

Last Updated: 2020-02-12

Results Overview

Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of the treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 1-30, a lower score is regarded as more severe.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 232 participants
• Primary outcome timeframe: 4 Weeks
• Results posted on: 2020-02-12

Participant Flow

Participant milestones

Measure	MED Placebo Then MED2005 Participants first receive MED Placebo to be used at least 4 times during a 4 week period. Following a 1-week treatment-free cross-over period participants receive MED2005 (0.2% glyceryl trinitrate gel) to be used at least 4 times during a 4 week period. Treatments are provided in single unit dose aluminium tubes packed in boxes of 5. Each tube will contain sufficient gel to apply a pea sized amount (approximately 300 mg).	MED2005 Then MED Placebo Participants first receive MED2005 (0.2% glyceryl trinitrate gel) to be used at least 4 times during a 4 week period. Following a 1-week treatment-free cross-over period participants receive MED Placebo to be used at least 4 times during a 4 week period. Treatments are provided in single unit dose aluminium tubes packed in boxes of 5. Each tube will contain sufficient gel to apply a pea sized amount (approximately 300 mg).
First Intervention (4 Weeks) STARTED	114	118
First Intervention (4 Weeks) COMPLETED	114	118
First Intervention (4 Weeks) NOT COMPLETED	0	0
Washout (1 Week) STARTED	114	118
Washout (1 Week) COMPLETED	112	116
Washout (1 Week) NOT COMPLETED	2	2
Second Intervention (4 Weeks) STARTED	112	116
Second Intervention (4 Weeks) COMPLETED	112	113
Second Intervention (4 Weeks) NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported.

Baseline characteristics by cohort

Measure	MED Placebo Then MED2005 n=114 Participants Participants first receive MED Placebo to be used at least 4 times during a 4 week period. Following a 1-week treatment-free cross-over period participants receive MED2005 (0.2% glyceryl trinitrate gel) to be used at least 4 times during a 4 week period. Treatments are provided in single unit dose aluminium tubes packed in boxes of 5. Each tube will contain sufficient gel to apply a pea sized amount (approximately 300 mg).	MED2005 Then MED Placebo n=117 Participants Participants first receive MED2005 (0.2% glyceryl trinitrate gel) to be used at least 4 times during a 4 week period. Following a 1-week treatment-free cross-over period participants receive MED Placebo to be used at least 4 times during a 4 week period. Treatments are provided in single unit dose aluminium tubes packed in boxes of 5. Each tube will contain sufficient gel to apply a pea sized amount (approximately 300 mg).	Total n=231 Participants Total of all reporting groups
Age, Continuous	42.7 years STANDARD_DEVIATION 13.7 • n=114 Participants	43.3 years STANDARD_DEVIATION 14.7 • n=117 Participants	43.0 years STANDARD_DEVIATION 14.2 • n=231 Participants
Sex: Female, Male Female	0 Participants n=114 Participants	0 Participants n=117 Participants	0 Participants n=231 Participants
Sex: Female, Male Male	114 Participants n=114 Participants	117 Participants n=117 Participants	231 Participants n=231 Participants
Race/Ethnicity, Customized Asian	5 Participants n=114 Participants	4 Participants n=117 Participants	9 Participants n=231 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=114 Participants	10 Participants n=117 Participants	17 Participants n=231 Participants
Race/Ethnicity, Customized White	97 Participants n=114 Participants	97 Participants n=117 Participants	194 Participants n=231 Participants
Race/Ethnicity, Customized Other	5 Participants n=114 Participants	6 Participants n=117 Participants	11 Participants n=231 Participants
Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF)	17.1 score on a scale STANDARD_DEVIATION 5.9 • n=113 Participants • Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported.	17.1 score on a scale STANDARD_DEVIATION 5.5 • n=117 Participants • Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported.	17.1 score on a scale STANDARD_DEVIATION 5.7 • n=230 Participants • Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported.

PRIMARY outcome

Timeframe: 4 Weeks

Population: Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.

Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of the treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 1-30, a lower score is regarded as more severe.

Outcome measures

Measure	MED Placebo n=225 Participants Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.	MED2005 n=223 Participants Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF)	18.5 score on a scale Standard Deviation 6.7	19.6 score on a scale Standard Deviation 7.5

SECONDARY outcome

Timeframe: 4 Weeks

Population: Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.

Orgasmic function domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 1-10, a lower score is regarded as having a worse outcome.

Outcome measures

Measure	MED Placebo n=225 Participants Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.	MED2005 n=223 Participants Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
Orgasmic Function Domain Score of the International Index of Erectile (IIEF)	6.6 score on a scale Standard Deviation 2.6	7.0 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 4 Weeks

Population: Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.

Sexual desire domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 2-10, a lower score is regarded as having a worse outcome.

Outcome measures

Measure	MED Placebo n=225 Participants Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.	MED2005 n=222 Participants Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
Sexual Desire Domain Score of the International Index of Erectile Function (IIEF)	7.1 score on a scale Standard Deviation 1.8	7.5 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 4 Weeks

Population: Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.

Intercourse satisfaction domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 0-15, a lower score is regarded as having a worse outcome.

Outcome measures

Measure	MED Placebo n=223 Participants Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.	MED2005 n=223 Participants Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
Intercourse Satisfaction Domain Score of the International Index of Erectile Function (IIEF)	8.6 score on a scale Standard Deviation 2.8	9.0 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 4 weeks

Population: Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.

Overall satisfaction domain of the International Index of Erectile Function (IIEF) questionnaire. This will be measured at the end of treatment periods of 4 weeks (+/- 1 week). The minimum and maximum values are 2-10, a lower score is regarded as having a worse outcome.

Outcome measures

Measure	MED Placebo n=225 Participants Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.	MED2005 n=222 Participants Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
Overall Satisfaction Domain Score of the International Index of Erectile Function (IIEF)	6.6 score on a scale Standard Deviation 2.2	7.1 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 4 Weeks

Population: Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.

SEP Question 1: "Were you able to achieve at least some erection (some enlargement of the penis)?". Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period.

Outcome measures

Measure	MED Placebo n=225 Participants Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.	MED2005 n=228 Participants Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 1	86.93 percentage of yes responses Standard Deviation 26.22	87.24 percentage of yes responses Standard Deviation 26.47

SECONDARY outcome

Timeframe: 4 Weeks

Population: Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.

SEP Question 2: "Were you able to insert your penis into your partner's vagina?". Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period.

Outcome measures

Measure	MED Placebo n=225 Participants Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.	MED2005 n=228 Participants Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 2	75.37 percentage of yes responses Standard Deviation 34.91	75.53 percentage of yes responses Standard Deviation 36.49

SECONDARY outcome

Timeframe: 4 Weeks

Population: Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.

SEP Question 3: "Did your erection last long enough for you to have successful intercourse?". Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period.

Outcome measures

Measure	MED Placebo n=225 Participants Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.	MED2005 n=228 Participants Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 3	52.64 percentage of yes responses Standard Deviation 38.81	57.32 percentage of yes responses Standard Deviation 39.40

SECONDARY outcome

Timeframe: 4 Weeks

Population: Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.

SEP Question 4: "Were you satisfied with the hardness of your erection?". Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period.

Outcome measures

Measure	MED Placebo n=225 Participants Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.	MED2005 n=228 Participants Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 4	28.97 percentage of yes responses Standard Deviation 33.12	42.91 percentage of yes responses Standard Deviation 41.0

SECONDARY outcome

Timeframe: 4 Weeks

Population: Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Observed cases only.

SEP Question 5: "Were you satisfied overall with this sexual experience?". Answered yes/no after each intercourse event during treatment periods of 4 weeks (+/- 1 week). Assessed as a percentage of yes responses in each period.

Outcome measures

Measure	MED Placebo n=225 Participants Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.	MED2005 n=228 Participants Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 5	36.88 percentage of yes responses Standard Deviation 36.98	48.23 percentage of yes responses Standard Deviation 40.87

SECONDARY outcome

Timeframe: 4 Weeks

Population: Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Complete cases only.

GAQ Question 1: "Has the treatment you have been taking improved your erectile function?". Answered yes/no after each treatment period of 4 weeks (+/- 1 week).

Outcome measures

Measure	MED Placebo n=216 Participants Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.	MED2005 n=216 Participants Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
Number of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 1	56 Participants	94 Participants

SECONDARY outcome

Timeframe: 4 Weeks

Population: Full Analysis Set. A total of 230 subjects reported at least one intercourse attempt and had at least one IIEF assessment in a period for which at least one intercourse attempt was reported. Complete cases only.

GAQ Question 2: "Has the treatment improved your ability to engage in sexual activity?". Answered yes/no after each treatment period of 4 weeks (+/- 1 week).

Outcome measures

Measure	MED Placebo n=216 Participants Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.	MED2005 n=216 Participants Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
Number of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 2	54 Participants	85 Participants

Adverse Events

MED Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

MED2005

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MED Placebo n=227 participants at risk Participants who received MED Placebo. At least 4 applications of MED Placebo prior to intercourse in either the first or last 4 weeks of the study.	MED2005 n=229 participants at risk Participants who received MED2005 (0.2% glyceryl trinitrate gel). At least 4 applications of MED2005 prior to intercourse in either the first or last 4 weeks of the study.
Infections and infestations Nasopharyngitis	4.8% 11/227 • 4 weeks Adverse events were assigned to a treatment as follows: * Period 1 treatment, if the onset date-time was on or after the first use of study medication of Period 1 and prior to the first study medication use of Period 2. * Period 2 treatment, if the onset date-time was on or after the first study medication use of Period 2. The number at risk are the number who actually used the corresponding treatment in the first and second intervention periods, subject to the cross-over sequence followed.	5.7% 13/229 • 4 weeks Adverse events were assigned to a treatment as follows: * Period 1 treatment, if the onset date-time was on or after the first use of study medication of Period 1 and prior to the first study medication use of Period 2. * Period 2 treatment, if the onset date-time was on or after the first study medication use of Period 2. The number at risk are the number who actually used the corresponding treatment in the first and second intervention periods, subject to the cross-over sequence followed.
Nervous system disorders Headache	3.1% 7/227 • 4 weeks Adverse events were assigned to a treatment as follows: * Period 1 treatment, if the onset date-time was on or after the first use of study medication of Period 1 and prior to the first study medication use of Period 2. * Period 2 treatment, if the onset date-time was on or after the first study medication use of Period 2. The number at risk are the number who actually used the corresponding treatment in the first and second intervention periods, subject to the cross-over sequence followed.	7.9% 18/229 • 4 weeks Adverse events were assigned to a treatment as follows: * Period 1 treatment, if the onset date-time was on or after the first use of study medication of Period 1 and prior to the first study medication use of Period 2. * Period 2 treatment, if the onset date-time was on or after the first study medication use of Period 2. The number at risk are the number who actually used the corresponding treatment in the first and second intervention periods, subject to the cross-over sequence followed.

Additional Information

Dr Jorg Taubel

Richmond Pharmacology Limited

Phone: 020 8664 5200

Email: j.taubel@richmondpharmacology.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER