Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02495467
Recruitment Status : Completed
First Posted : July 13, 2015
Results First Posted : January 29, 2020
Last Update Posted : February 12, 2020
Sponsor:
Collaborator:
Richmond Pharmacology Limited
Information provided by (Responsible Party):
Futura Medical Developments Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Erectile Dysfunction
Interventions Drug: Glyceryl trinitrate
Drug: MED Placebo
Enrollment 232
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MED Placebo Then MED2005 MED2005 Then MED Placebo
Hide Arm/Group Description 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). 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).
Period Title: First Intervention (4 Weeks)
Started 114 118
Completed 114 118 [1]
Not Completed 0 0
[1]
One subject completed visits in treatment Period 1 but never used treatment
Period Title: Washout (1 Week)
Started 114 118
Completed 112 116
Not Completed 2 2
Period Title: Second Intervention (4 Weeks)
Started 112 116
Completed 112 113
Not Completed 0 3
Arm/Group Title MED Placebo Then MED2005 MED2005 Then MED Placebo Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 114 117 231
Hide Baseline Analysis Population Description
Safety Set. A total of 231 subjects made use of the medication at least once and were included in the safety set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 117 participants 231 participants
42.7  (13.7) 43.3  (14.7) 43.0  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 117 participants 231 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
114
 100.0%
117
 100.0%
231
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 114 participants 117 participants 231 participants
5
   4.4%
4
   3.4%
9
   3.9%
Black or African American Number Analyzed 114 participants 117 participants 231 participants
7
   6.1%
10
   8.5%
17
   7.4%
White Number Analyzed 114 participants 117 participants 231 participants
97
  85.1%
97
  82.9%
194
  84.0%
Other Number Analyzed 114 participants 117 participants 231 participants
5
   4.4%
6
   5.1%
11
   4.8%
Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 113 participants 117 participants 230 participants
17.1  (5.9) 17.1  (5.5) 17.1  (5.7)
[1]
Measure Description: Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) questionnaire. Measured at the end of a 4 week (+/- 1 week) run-in period. The minimum and maximum values are 1-30, a lower score is regarded as more severe.
[2]
Measure Analysis Population Description: 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.
1.Primary Outcome
Title Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF)
Hide Description 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.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MED Placebo MED2005
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 225 223
Mean (Standard Deviation)
Unit of Measure: score on a scale
18.5  (6.7) 19.6  (7.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MED Placebo, MED2005
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0132
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.22 to 1.84
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Orgasmic Function Domain Score of the International Index of Erectile (IIEF)
Hide Description 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.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MED Placebo MED2005
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 225 223
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.6  (2.6) 7.0  (2.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MED Placebo, MED2005
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0122
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
0.09 to 0.73
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Sexual Desire Domain Score of the International Index of Erectile Function (IIEF)
Hide Description 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.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MED Placebo MED2005
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 225 222
Mean (Standard Deviation)
Unit of Measure: score on a scale
7.1  (1.8) 7.5  (1.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MED Placebo, MED2005
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
0.21 to 0.57
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Intercourse Satisfaction Domain Score of the International Index of Erectile Function (IIEF)
Hide Description 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.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MED Placebo MED2005
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 223 223
Mean (Standard Deviation)
Unit of Measure: score on a scale
8.6  (2.8) 9.0  (2.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MED Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0055
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
0.12 to 0.69
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Overall Satisfaction Domain Score of the International Index of Erectile Function (IIEF)
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MED Placebo MED2005
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 225 222
Mean (Standard Deviation)
Unit of Measure: score on a scale
6.6  (2.2) 7.1  (2.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MED Placebo, MED2005
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.20 to 0.76
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 1
Hide Description 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.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MED Placebo MED2005
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 225 228
Mean (Standard Deviation)
Unit of Measure: percentage of yes responses
86.93  (26.22) 87.24  (26.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MED Placebo, MED2005
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7999
Comments [Not Specified]
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Means ratio
Estimated Value 0.995
Confidence Interval (2-Sided) 95%
0.960 to 1.032
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 2
Hide Description 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.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MED Placebo MED2005
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 225 228
Mean (Standard Deviation)
Unit of Measure: percentage of yes responses
75.37  (34.91) 75.53  (36.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MED Placebo, MED2005
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6746
Comments [Not Specified]
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Means ratio
Estimated Value 0.989
Confidence Interval (2-Sided) 95%
0.937 to 1.043
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 3
Hide Description 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.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MED Placebo MED2005
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 225 228
Mean (Standard Deviation)
Unit of Measure: percentage of yes responses
52.64  (38.81) 57.32  (39.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MED Placebo, MED2005
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0959
Comments [Not Specified]
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Means ratio
Estimated Value 1.075
Confidence Interval (2-Sided) 95%
0.987 to 1.170
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 4
Hide Description 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.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MED Placebo MED2005
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 225 228
Mean (Standard Deviation)
Unit of Measure: percentage of yes responses
28.97  (33.12) 42.91  (41.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MED Placebo, MED2005
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Means ratio
Estimated Value 1.522
Confidence Interval (2-Sided) 95%
1.267 to 1.829
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 5
Hide Description 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.
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MED Placebo MED2005
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 225 228
Mean (Standard Deviation)
Unit of Measure: percentage of yes responses
36.88  (36.98) 48.23  (40.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MED Placebo, MED2005
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Means ratio
Estimated Value 1.320
Confidence Interval (2-Sided) 95%
1.128 to 1.545
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 1
Hide Description 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).
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MED Placebo MED2005
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 216 216
Measure Type: Count of Participants
Unit of Measure: Participants
56
  25.9%
94
  43.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MED Placebo, MED2005
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Prescott Test (Exact)
Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 2
Hide Description 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).
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MED Placebo MED2005
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 216 216
Measure Type: Count of Participants
Unit of Measure: Participants
54
  25.0%
85
  39.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MED Placebo, MED2005
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Prescott Test (Exact)
Comments [Not Specified]
Time Frame 4 weeks
Adverse Event Reporting Description

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.

 
Arm/Group Title MED Placebo MED2005
Hide Arm/Group Description 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. 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.
All-Cause Mortality
MED Placebo MED2005
Affected / at Risk (%) Affected / at Risk (%)
Total   0/227 (0.00%)   0/229 (0.00%) 
Hide Serious Adverse Events
MED Placebo MED2005
Affected / at Risk (%) Affected / at Risk (%)
Total   0/227 (0.00%)   0/229 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MED Placebo MED2005
Affected / at Risk (%) Affected / at Risk (%)
Total   15/227 (6.61%)   28/229 (12.23%) 
Infections and infestations     
Nasopharyngitis  1  11/227 (4.85%)  13/229 (5.68%) 
Nervous system disorders     
Headache  1  7/227 (3.08%)  18/229 (7.86%) 
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Jorg Taubel
Organization: Richmond Pharmacology Limited
Phone: 020 8664 5200
EMail: j.taubel@richmondpharmacology.com
Layout table for additonal information
Responsible Party: Futura Medical Developments Ltd.
ClinicalTrials.gov Identifier: NCT02495467    
Other Study ID Numbers: FM53
First Submitted: June 29, 2015
First Posted: July 13, 2015
Results First Submitted: April 9, 2018
Results First Posted: January 29, 2020
Last Update Posted: February 12, 2020