Erectile DysfunctionPhase 2NCT02495467
Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED)
A Phase 2 study testing Glyceryl trinitrate in people with Erectile Dysfunction, run by Futura Medical Developments Ltd. at 1 site in United Kingdom.
Trial summary
This study is designed to evaluate the efficacy and safety of MED2005, a topically applied glyceryl trinitrate (GTN) gel administered to the penis of male subjects self-diagnosed with erectile dysfunction (ED) immediately before sexual intercourse. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Glyceryl trinitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2015to 30 Jul 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male aged between 18 and 70 years of age inclusive.
- Confirmed self-diagnosis of ED for more than 3 months.
- IIEF question 1 -5 and 15 score of 25 or less will be acceptable for inclusion to the run-in period.
- Subject answers "yes" to the question "At home over the past 3 months, have you experienced at least some growth of your penis in response to: (1) mechanical stimulation, or (2) visual stimulation?"
- In a continuous heterosexual relationship for at least 6 months prior to screening.
- Documented written informed consent from both subject and his female partner.
Show all 14Show fewer
- Both partners must agree to use one of the acceptable methods of contraception listed below:
- Occlusive cap (diaphragm or cervical/vault caps).
- Surgical sterilisation (vasectomy with documentation of azoospermia).
- The female partner uses oral contraceptives, injectable progesterone or subdermal implants.
- The female partner uses medically prescribed topically-applied transdermal contraceptive patch.
- The female partner has undergone documented tubal ligation (female sterilisation).
- The female partner has undergone documented placement of an Intra Uterine Device (IUD).
- Both partners are capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form.
Who cannot join
- Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease.
- Any history of an unstable medical or psychiatric condition or using any medication that, in the opinion of the PI, is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
- Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or delegate at screening.
- Any presence of chronic indwelling urethral catheterization or penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
- Any history of operations for Peyronie's disease.
- Primary hypoactive sexual desire or any history of hypogonadism
Show all 22Show fewer
- Any history of radical prostatectomy.
- Any history of severe / uncontrolled diabetes.
- Subjects taking two or more anti-hypertensives for the treatment of blood pressure.
- Subjects with nursing partners, known pregnant partners or wish to become pregnant during the course of the study.
- Confirmed positive results from urine drug screen or from the alcohol breath test at screening and on admission (Day -1).
- Subject has recent (last 12 months) clinical evidence of alcoholism or drug abuse.
- Subject has a positive screen for hepatitis B consisting of Hepatitis B surface antigen (HBsAG), hepatitis C antibody, and human immunodeficiency virus (HIV).
- Any clinically significant abnormal laboratory, vital signs or other safety findings at screening or on admission.
- Subjects unwilling to cease use of vacuum devices, intracavernosal injection, Viagra ® or other therapy for ED.
- Unwillingness of the subject to agree to make four attempts at sexual intercourse on four separate days during each treatment period.
- Any history of unresponsiveness to Viagra ® treatment due to lack of efficacy with sexual stimulation after multiple attempts of sexual intercourse, or significant side effects excluding visual disturbances of Viagra ®.
- Less than 4 attempts at sexual intercourse or high IIEF scores (> 25) during the run-in period.
- Any known hypersensitivity to any component of the investigational product.
- Subjects who are illiterate or are unable to understand the language in which the online questionnaires are available.
- Subject has received any investigational product during the 90 days prior to dosing for this study.
- Subject or their partner cannot communicate reliably with the Investigator.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Richmond Pharmacology Ltd.
Croydon, Surrey, CR7 7YE
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Home Use, Cross-over Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED)
This study is designed to evaluate the efficacy and safety of MED2005, a topically applied glyceryl trinitrate (GTN) gel administered to the penis of male subjects self-diagnosed with erectile dysfunction (ED) immediately before sexual intercourse.
Read the detailed description
This randomised, double-blind, placebo-controlled cross-over study is designed to evaluate the efficacy and safety of MED2005, a topically applied glyceryl trinitrate (GTN) gel administered to the penis of male subjects immediately before sexual intercourse. Subjects will be male aged between 18 and 70 years of age self-diagnosed with ED. Treatment requires the topical application of a pea sized volume (approximately 300 mg) of a 0.2% (w/w) gel to deliver a dose of 0.6 mg GTN to the glans of the penis. A total of 192 eligible subjects are planned to be enrolled into the study. Subjects will be screened for eligibility during the screening period (Day -45 to Day -2), provide a history of their ED treatments and those deemed eligible and who have a female consenting partner will participate in a run-in-period and two treatment periods (treatment period 1 and 2). The International Index for Erectile Function (IIEF) question 1 -5 and 15 will be used to determine pre-screening eligibility for the subject online. A score of 25 or less will be acceptable for inclusion to the run-in-period. Screening (visit 1) will be conducted over 1 day or may be divided into more than 1 day if wash-out of prior medications is needed. The screening period is applicable for visit 1 Informed consent will be signed by both partners before a couple can be admitted to the study. There will also be a subject and partner training requirement to ensure that the product is applied in an appropriate manner. After refraining from using other ED treatments for at least a period of a week, in the run-in-period (visit 2), subjects and their female partners will make at least 4 intercourse attempts (with a minimum of 1 attempt per week) during a 4 week (± 1 week) period. The subjects and their partners will be asked to complete questionnaires online to record their experiences after each sexual intercourse attempt and at the end of the run-in period. Subjects who cannot comply with the minimum number of sexual attempts verified by completed Sexual Event Profile (SEP) or exceed 25 on the IIEF question 1 -5 and 15 will be excluded from the study. Scores generated from the run-in period will be used as an established baseline in the planned analyses. The run-in period will be completed prior to randomisation and dosing.
In treatment period 1 (visit 3 and visit 4), subjects will be allocated to receive either placebo or MED2005 (0.6 mg GTN) according to a pre-defined randomisation schedule. After refraining from using other ED treatments for at least a period of a week, subjects and their female partner will be trained in the application of the test article and asked to apply the test article immediately prior to sexual intercourse, and to make at least 4 intercourse attempts during a 4 week (± 1 week) period. The subjects and their partners will be asked to complete questionnaires online to record their experiences after each sexual intercourse attempt, and again at the end of each treatment period. Subjects will be asked to return to the Clinical Pharmacology Unit (CPU) after 4 weeks' (± 1 week) to return used and unused test article from the first treatment period, to enable the clinical staff to check compliance and to assess their health status, including assessment of any Adverse Event (AE). At the end of treatment period 1 (visit 4), tubes will be weighed to ensure subject compliance.
Following a 1 week treatment-free cross-over period, the subjects will enter into treatment period 2.
In treatment period 2 (visit 5 and visit 6), subjects will be issued with the alternative test article, either placebo or MED2005 (0.6 mg GTN) according to the pre-defined randomisation code. Training on the application of the test article will be reinforced / repeated and the subject or their female partner will be asked to apply the test article immediately prior to sexual intercourse on at least 4 separate occasions during a 4-week period. After each intercourse attempt the subjects and their partners will be asked to complete questionnaires online to record their experiences after each sexual intercourse attempt, and again at the end of each treatment period.. Subjects will be asked to return to the CPU after 4 weeks' (± 1 week) time to return used and unused test article from the second treatment period, to enable the clinical staff to check compliance and to assess their health status, including assessment of any AEs. At the end of treatment period 2 (visit 6), tubes will be weighed to ensure subject compliance.
Subjects and their female partners will be followed up at 7 day's ± 2 days (visit 7) after the outpatient visit on week 4 of treatment period 2, as necessary, to follow up any on-going AEs.
- Conditions
- Erectile Dysfunction
- Being tested
- Glyceryl trinitrate, MED Placebo
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glyceryl trinitrateDrug
Also called MED2005
At least 4 applications of MED2005 prior to intercourse over a period of 4 weeks
MED PlaceboDrug
Also called MED2005 Vehicle
At least 4 applications of MED2005 prior to intercourse over a period of 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| MED Placebo then MED2005 | Experimental | 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). Receives: Drug: Glyceryl trinitrate; Drug: MED Placebo |
| MED2005 then MED Placebo | Experimental | 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). Receives: Drug: Glyceryl trinitrate; Drug: MED Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF)
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.
Measured: 4 Weeks
Secondary outcomes (11)
Orgasmic Function Domain Score of the International Index of Erectile (IIEF)
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.
Measured: 4 Weeks
Sexual Desire Domain Score of the International Index of Erectile Function (IIEF)
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.
Measured: 4 Weeks
Intercourse Satisfaction Domain Score of the International Index of Erectile Function (IIEF)
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.
Measured: 4 Weeks
Overall Satisfaction Domain Score of the International Index of Erectile Function (IIEF)
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.
Measured: 4 weeks
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 1
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.
Measured: 4 Weeks
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 2
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.
Measured: 4 Weeks
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 3
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.
Measured: 4 Weeks
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 4
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.
Measured: 4 Weeks
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 5
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.
Measured: 4 Weeks
Number of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 1
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).
Measured: 4 Weeks
Number of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 2
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).
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study start15 May 2015
- Primary completion30 Jul 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Futura Medical Developments Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Responsible party
- Sponsor
- Investigators
- Tim J Holland, MSc, Study director, Futura Medical Developments Ltd.Jörg Täubel, MD FFPM, Principal investigator, Richmond Pharmacology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495467
- Sponsor's protocol ID
- FM53
- Status last verified
- Jan 2020
- First submitted
- 29 Jun 2015
- Last updated
- 12 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Home Use, Cross-over Clinical Trial of Topically-applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction (ED)
- ClinicalTrials.gov ID
- NCT02495467
- Acronym / sponsor ID
- FM53
- Conditions
- Erectile Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Futura Medical Developments Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Study start
- 15 May 2015 (actual)
- Primary completion
- 30 Jul 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Posted 29 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the efficacy and safety of MED2005, a topically applied glyceryl trinitrate (GTN) gel administered to the penis of male subjects self-diagnosed with erectile dysfunction (ED) immediately before sexual intercourse.
Detailed description
This randomised, double-blind, placebo-controlled cross-over study is designed to evaluate the efficacy and safety of MED2005, a topically applied glyceryl trinitrate (GTN) gel administered to the penis of male subjects immediately before sexual intercourse. Subjects will be male aged between 18 and 70 years of age self-diagnosed with ED. Treatment requires the topical application of a pea sized volume (approximately 300 mg) of a 0.2% (w/w) gel to deliver a dose of 0.6 mg GTN to the glans of the penis. A total of 192 eligible subjects are planned to be enrolled into the study. Subjects will be screened for eligibility during the screening period (Day -45 to Day -2), provide a history of their ED treatments and those deemed eligible and who have a female consenting partner will participate in a run-in-period and two treatment periods (treatment period 1 and 2). The International Index for Erectile Function (IIEF) question 1 -5 and 15 will be used to determine pre-screening eligibility for the subject online. A score of 25 or less will be acceptable for inclusion to the run-in-period. Screening (visit 1) will be conducted over 1 day or may be divided into more than 1 day if wash-out of prior medications is needed. The screening period is applicable for visit 1 Informed consent will be signed by both partners before a couple can be admitted to the study. There will also be a subject and partner training requirement to ensure that the product is applied in an appropriate manner. After refraining from using other ED treatments for at least a period of a week, in the run-in-period (visit 2), subjects and their female partners will make at least 4 intercourse attempts (with a minimum of 1 attempt per week) during a 4 week (± 1 week) period. The subjects and their partners will be asked to complete questionnaires online to record their experiences after each sexual intercourse attempt and at the end of the run-in period. Subjects who cannot comply with the minimum number of sexual attempts verified by completed Sexual Event Profile (SEP) or exceed 25 on the IIEF question 1 -5 and 15 will be excluded from the study. Scores generated from the run-in period will be used as an established baseline in the planned analyses. The run-in period will be completed prior to randomisation and dosing.
In treatment period 1 (visit 3 and visit 4), subjects will be allocated to receive either placebo or MED2005 (0.6 mg GTN) according to a pre-defined randomisation schedule. After refraining from using other ED treatments for at least a period of a week, subjects and their female partner will be trained in the application of the test article and asked to apply the test article immediately prior to sexual intercourse, and to make at least 4 intercourse attempts during a 4 week (± 1 week) period. The subjects and their partners will be asked to complete questionnaires online to record their experiences after each sexual intercourse attempt, and again at the end of each treatment period. Subjects will be asked to return to the Clinical Pharmacology Unit (CPU) after 4 weeks' (± 1 week) to return used and unused test article from the first treatment period, to enable the clinical staff to check compliance and to assess their health status, including assessment of any Adverse Event (AE). At the end of treatment period 1 (visit 4), tubes will be weighed to ensure subject compliance.
Following a 1 week treatment-free cross-over period, the subjects will enter into treatment period 2.
In treatment period 2 (visit 5 and visit 6), subjects will be issued with the alternative test article, either placebo or MED2005 (0.6 mg GTN) according to the pre-defined randomisation code. Training on the application of the test article will be reinforced / repeated and the subject or their female partner will be asked to apply the test article immediately prior to sexual intercourse on at least 4 separate occasions during a 4-week period. After each intercourse attempt the subjects and their partners will be asked to complete questionnaires online to record their experiences after each sexual intercourse attempt, and again at the end of each treatment period.. Subjects will be asked to return to the CPU after 4 weeks' (± 1 week) time to return used and unused test article from the second treatment period, to enable the clinical staff to check compliance and to assess their health status, including assessment of any AEs. At the end of treatment period 2 (visit 6), tubes will be weighed to ensure subject compliance.
Subjects and their female partners will be followed up at 7 day's ± 2 days (visit 7) after the outpatient visit on week 4 of treatment period 2, as necessary, to follow up any on-going AEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MED Placebo then MED2005 | Experimental | Drug: Glyceryl trinitrate, Drug: MED PlaceboParticipants 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 | Experimental | Drug: Glyceryl trinitrate, Drug: MED PlaceboParticipants 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male aged between 18 and 70 years of age inclusive.
- Confirmed self-diagnosis of ED for more than 3 months.
- IIEF question 1 -5 and 15 score of 25 or less will be acceptable for inclusion to the run-in period.
- Subject answers "yes" to the question "At home over the past 3 months, have you experienced at least some growth of your penis in response to: (1) mechanical stimulation, or (2) visual stimulation?"
- In a continuous heterosexual relationship for at least 6 months prior to screening.
Key exclusion criteria (22 listed)
- Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease.
- Any history of an unstable medical or psychiatric condition or using any medication that, in the opinion of the PI, is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
- Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or delegate at screening.
- Any presence of chronic indwelling urethral catheterization or penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
- Any history of operations for Peyronie's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glyceryl trinitrateAlso: MED2005At least 4 applications of MED2005 prior to intercourse over a period of 4 weeks | Drug | MED Placebo then MED2005, MED2005 then MED Placebo |
| MED PlaceboAlso: MED2005 VehicleAt least 4 applications of MED2005 prior to intercourse over a period of 4 weeks | Drug | MED Placebo then MED2005, MED2005 then MED Placebo |
Primary outcome
Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF)
Time frame: 4 Weeks
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.
11 secondary outcomes
Orgasmic Function Domain Score of the International Index of Erectile (IIEF)
Time frame: 4 Weeks
Sexual Desire Domain Score of the International Index of Erectile Function (IIEF)
Time frame: 4 Weeks
Intercourse Satisfaction Domain Score of the International Index of Erectile Function (IIEF)
Time frame: 4 Weeks
Overall Satisfaction Domain Score of the International Index of Erectile Function (IIEF)
Time frame: 4 weeks
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 1
Time frame: 4 Weeks
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 2
Time frame: 4 Weeks
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 3
Time frame: 4 Weeks
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 4
Time frame: 4 Weeks
Percentage of Affirmative Responses to Sexual Encounter Profile (SEP) Question 5
Time frame: 4 Weeks
Number of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 1
Time frame: 4 Weeks
Number of Participants With Affirmative Response to Global Assessment Questionnaire (GAQ) Question 2
Time frame: 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim J Holland, MSc study director
Futura Medical Developments Ltd.
Jörg Täubel, MD FFPM principal investigator
Richmond Pharmacology Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glyceryl trinitrate in people with Erectile Dysfunction, run by Futura Medical Developments Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF) (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.