Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
- Conditions
- Erectile Dysfunction
- Interventions
- Device: MED3000 (Male)Device: MED3000 (Female)
- Registration Number
- NCT04984993
- Lead Sponsor
- Futura Medical Developments Ltd.
- Brief 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. Eligible patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets in a 1:1 ratio.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 116
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tadalafil Tadalafil 5mg (Female) Tadalafil (5 mg) tablets to be taken orally Tadalafil Tadalafil 5mg (Male) Tadalafil (5 mg) tablets to be taken orally MED3000 MED3000 (Female) MED3000 gel formulation topically applied to the glans penis MED3000 MED3000 (Male) MED3000 gel formulation topically applied to the glans penis
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000. 24 weeks 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?Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000. 24 weeks 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?
Trial Locations
- Locations (18)
Provita Sp. z o.o.
🇵🇱Katowice, Poland
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Medical Center "Asklepii"OOD
🇧🇬Dupnitsa, Bulgaria
ЕТ "Аssoc. Prof. Stefan Popov - Individual Practice for Specialized Outhospital medical care for Neurology and Pscyhiatry"
🇧🇬Plovdiv, Bulgaria
MHAT "Silistra"AD
🇧🇬Silistra, Bulgaria
UMHAT Plovdiv AD
🇧🇬Plovdiv, Bulgaria
Medical Center "INTERMEDICA"ООD
🇧🇬Sofia, Bulgaria
LTD Health
🇬🇪Batumi, Georgia
Rustavi N2 Medical Diagnostic Center
🇬🇪Rustavi, Georgia
Jsc "Evex Clinics"
🇬🇪Kutaisi, Georgia
Clinic "GIDMEDI"
🇬🇪Tbilisi, Georgia
Raymann LLC
🇬🇪Tbilisi, Georgia
JSC "Evex clinics"
🇬🇪Tbilisi, Georgia
The Mikolowska Medical Center
🇵🇱Katowice, Poland
PROVITA Specialised Gynecology and Sexology Practice
🇵🇱Lublin, Poland
Medistica Osteomed
🇵🇱Kraków, Poland
Ryszard Smoliński's Medical Cabinet
🇵🇱Wrocław, Poland
Sexology and Pathology of Intercourse Clinic
🇵🇱Warsaw, Poland