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:
Futura Medical Developments Ltd.
Collaborator:
Richmond Pharmacology Limited
Information provided by (Responsible Party):
Futura Medical Developments Ltd.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| 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 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | MED Placebo Then MED2005 | MED2005 Then MED Placebo |
|---|---|---|
 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 |
Baseline Characteristics
| Arm/Group Title | MED Placebo Then MED2005 | MED2005 Then MED Placebo | Total | |
|---|---|---|---|---|
|
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 | |
|
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.
|
||||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Dr Jorg Taubel |
| Organization: | Richmond Pharmacology Limited |
| Phone: | 020 8664 5200 |
| EMail: | j.taubel@richmondpharmacology.com |
| 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 |