Erectile DysfunctionPhase 3NCT04984993
Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
A Phase 3 study testing MED3000 (Male), Tadalafil 5mg (Male) and MED3000 (Female) in people with Erectile Dysfunction, run by Futura Medical Developments Ltd. at 18 sites in 4 countries.
Trial summary
An open-label investigation using MED3000 gel or tadalafil (5 mg) tablets in the treatment of erectile dysfunction in patients from 22 to 70 years of age. Each patients will be expected to participate for up to 30 weeks. Read more about this study
- Who is it for?
- Ages 22 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- MED3000 (Male), Tadalafil 5mg (Male) and MED3000 (Female)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 14 Sep 2021to 13 Jul 2022
- Phase
- Phase 3
- 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 22 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male heterosexual patients aged 22-70 years.
- Confirmed clinical diagnosis of mild, moderate or severe ED for more than 3 months.
- Involved in a continuous heterosexual relationship with their partner for at least 6 months.
Who cannot join
- Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease.
- History of unstable medical or psychiatric condition or using any medication that, in the opinion of the Principal Investigator, is likely to affect the patient's ability to complete the investigation or precludes the patient's participation in the investigation.
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Georgia6 sites
LTD Health
Batumi
Jsc "Evex Clinics"
Kutaisi, 4600
Rustavi N2 Medical Diagnostic Center
Rustavi, 3700
Clinic "GIDMEDI"
Tbilisi, 0112
JSC "Evex clinics"
Tbilisi, 0160
Raymann LLC
Tbilisi, 0162
Poland6 sites
The Mikolowska Medical Center
Katowice, 40-065
Provita Sp. z o.o.
Katowice, 40-611
Medistica Osteomed
Krakow, 30-074
PROVITA Specialised Gynecology and Sexology Practice
Lublin, 20-93
Sexology and Pathology of Intercourse Clinic
Warsaw, 05-077
Ryszard Smoliński's Medical Cabinet
Wroclaw, 53-532
Bulgaria5 sites
Medical Center "Asklepii"OOD
Dupnitsa, 2600
ЕТ "Аssoc. Prof. Stefan Popov - Individual Practice for Specialized Outhospital medical care for Neurology and Pscyhiatry"
Plovdiv, 4002
UMHAT Plovdiv AD
Plovdiv
MHAT "Silistra"AD
Silistra, 7500
Medical Center "INTERMEDICA"ООD
Sofia, 1000
About this study
Official title: A Multi-centre, Randomised, Open-label, Home Use, Parallel Group, Clinical Investigation of Topically-applied MED3000 Gel and Oral Tadalafil (5 mg) Tablets for the Treatment of Erectile Dysfunction (ED) Over a 24 Week Period
An open-label investigation using MED3000 gel or tadalafil (5 mg) tablets in the treatment of erectile dysfunction in patients from 22 to 70 years of age. Each patients will be expected to participate for up to 30 weeks. Eligible patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets in a 1:1 ratio.
- Conditions
- Erectile Dysfunction
- Being tested
- MED3000 (Male), Tadalafil 5mg (Male), MED3000 (Female), Tadalafil 5mg (Female)
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MED3000 (Male)Device
Gel formulation
Tadalafil 5mg (Male)Drug
Tablets
MED3000 (Female)Device
Gel formulation
Tadalafil 5mg (Female)Drug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| MED3000 | Experimental | MED3000 gel formulation topically applied to the glans penis Receives: Device: MED3000 (Male); Device: MED3000 (Female) |
| Tadalafil | Experimental | Tadalafil (5 mg) tablets to be taken orally Receives: Drug: Tadalafil 5mg (Male); Drug: Tadalafil 5mg (Female) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire, in Patients Randomised to MED3000, at Week 24
Co-primary objectives:
- Demonstrate an improvement compared to baseline of erectile function, in patients randomised to receive MED3000, using the IIEF-EF patient reported outcome instrument.
- Observe a mean change from baseline of the IIEF-EF, in patients randomised to MED3000, greater or equal to the minimal clinically importance difference of 4.
The IIEF is a validated questionnaire, consisting of 15 questions, for detecting treatment changes in EF. The EF domain of IIEF is derived using questions 1, 2, 3, 4, 5 and 15. A score of 0 to 5 is awarded to each of questions 1 to 5 and a score of 1 to 5 is awarded to question 15. Higher scores indicate better sexual function. Domain score is computed by summing the scores for individual questions. The minimum and maximum possible scores are 1 and 30 respectively. Patients with a score of 21 or less are considered to have ED. Change from baseline = Week 24 score - Baseline score.
Measured: Baseline and Week 24
Secondary outcomes (2)
Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000.
Demonstrate a speed of onset of action from application of MED3000 gel to the time when patient notices their erection starting.
Percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within certain period of time, out of the total number of intercourse attempts made using the product during the 24-week treatment period. The certain periods of time are within 15 minutes, 10 minutes and 5 minutes. Percentage of uses is calculated with the denominator equal to the total number of intercourse attempts made using the product during the 24-week treatment period and the numerator equal to the total number of times that the response to the onset of action question 1 indicated a time of 5 (10, 15) minutes or less.
Question 1 of the Onset of Action questionnaire:
- After application of the gel/taking medication, when did you begin to notice your erection starting?
Measured: 24 weeks
Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000.
Demonstrate a speed of onset of action from application of MED3000 gel to the time when the patients is able to have penetrative sex.
Percentage of MED3000 uses per patient that resulted in the patient being able to have penetrative sex within certain period of time, out of the total number of intercourse attempts made using the product during the 24-week treatment period. The certain periods of time are within 15 minutes, 10 minutes and 5 minutes. Percentage of uses is calculated with the denominator equal to the total number of intercourse attempts made using the product during the 24-week treatment period and the numerator equal to the total number of times that the response to the onset of action question 2 indicated a time of 5 (10, 15) minutes or less.
Question 2 of the Onset of Action questionnaire:
- After application of the gel/taking medication, when were you able to have penetrative sex?
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start14 Sep 2021
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets after a 4 -6 week screening period
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Futura Medical Developments Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur Burnett, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984993
- Sponsor's protocol ID
- FM71
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Open-label, Home Use, Parallel Group, Clinical Investigation of Topically-applied MED3000 Gel and Oral Tadalafil (5 mg) Tablets for the Treatment of Erectile Dysfunction (ED) Over a 24 Week Period
- ClinicalTrials.gov ID
- NCT04984993
- Acronym / sponsor ID
- FM71
- Conditions
- Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Futura Medical Developments Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label investigation using MED3000 gel or tadalafil (5 mg) tablets in the treatment of erectile dysfunction in patients from 22 to 70 years of age. Each patients will be expected to participate for up to 30 weeks. Eligible patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets in a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets after a 4 -6 week screening period
| Arm | Type | Receives |
|---|---|---|
| MED3000 | Experimental | Device: MED3000 (Male), Device: MED3000 (Female)MED3000 gel formulation topically applied to the glans penis |
| Tadalafil | Experimental | Drug: Tadalafil 5mg (Male), Drug: Tadalafil 5mg (Female)Tadalafil (5 mg) tablets to be taken orally |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male heterosexual patients aged 22-70 years.
- Confirmed clinical diagnosis of mild, moderate or severe ED for more than 3 months.
- Involved in a continuous heterosexual relationship with their partner for at least 6 months.
Key exclusion criteria (2 listed)
- Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease.
- History of unstable medical or psychiatric condition or using any medication that, in the opinion of the Principal Investigator, is likely to affect the patient's ability to complete the investigation or precludes the patient's participation in the investigation.
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 |
|---|---|---|
| MED3000 (Male)Gel formulation | Device | MED3000 |
| Tadalafil 5mg (Male)Tablets | Drug | Tadalafil |
| MED3000 (Female)Gel formulation | Device | MED3000 |
| Tadalafil 5mg (Female)Tablets | Drug | Tadalafil |
Primary outcome
Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire, in Patients Randomised to MED3000, at Week 24
Time frame: Baseline and Week 24
Co-primary objectives: * Demonstrate an improvement compared to baseline of erectile function, in patients randomised to receive MED3000, using the IIEF-EF patient reported outcome instrument. * Observe a mean change from baseline of the IIEF-EF, in patients randomised to MED3000, greater or equal to the minimal clinically importance difference of 4. The IIEF is a validated questionnaire, consisting of 15 questions, for detecting treatment changes in EF. The EF domain of IIEF is derived using questions 1, 2, 3, 4, 5 and 15. A score of 0 to 5 is awarded to each of questions 1 to 5 and a score of 1 to 5 is awarded to question 15. Higher scores indicate better sexual function. Domain score is computed by summing the scores for individual questions. The minimum and maximum possible scores are 1 and 30 respectively. Patients with a score of 21 or less are considered to have ED. Change from baseline = Week 24 score - Baseline score.
2 secondary outcomes
Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000.
Time frame: 24 weeks
Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000.
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- 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.
Arthur Burnett, MD principal investigator
Johns Hopkins University
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MED3000 (Male), Tadalafil 5mg (Male) and MED3000 (Female) in people with Erectile Dysfunction, run by Futura Medical Developments Ltd. at 18 sites in 4 countries.
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 3 inclusion and 2 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Georgia, Poland, Bulgaria, United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 21 Sep 2023). 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?
Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire, in Patients Randomised to MED3000, at Week 24 (time frame: Baseline and Week 24). 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 21 Sep 2023.