Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction

Study Overview
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Brief Summary
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This is a randomized, double blind, placebo-controlled, comparative, prospective study (clinical evaluation) of the effectiveness and safety of dietary supplement Potensa in men with mild to moderate erectile dysfunction.

Official Title
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Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Dietary Supplement: Potensa, a succinate-based dietary supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men, 18 years of age or older; Patients diagnosed with erectile dysfunctions of various pathogenesis, typical form without complications; Ability to read and understand informed consent in order to participate in the study; Ability to follow study's conditions. Exclusion Criteria: Oncological illnesses, except those in complete remission for at least 5 years; Conditions that may require emergency or planned hospitalization in the next 6 months; Extragenital endocrine conditions (hormonally active) (thyroid, adrenal glands, pituitary, hypothalamus); Surgeries on sex organ within 1 year of the screening; Any surgeries within 3 months of the screening; Psychiatric illnesses; Diabetes mellitus; Cryptorchidism Taking other dietary supplements that can affect erectile dysfunction within 1 month of participating in the study; High risk of non-compliance.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Potensa<br>succinate-based dietary supplement | Dietary Supplement: Potensa, a succinate-based dietary supplement<br>* Potensa - a dietary supplement: 4 capsules (2 white 200mg each and 2 blue 200 mg each) once a day with a meal or immediately after a meal, preferably after breakfast, for 3 months.<br>|
| Placebo Comparator: Placebo<br>placebo | Dietary Supplement: Placebo<br>* Placebo: 4 capsules (2 white 200mg each and 2 blue 200 mg each) once a day with a meal or immediately after a meal, preferably after breakfast, for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the International Index of Erectile Function (IIEF) score | Self reported erectile function; higher score indicates less dysfunction | Baseline - 30 days | 
| Change from baseline in the International Index of Erectile Function (IIEF) score | Self reported erectile function; higher score indicates less dysfunction | Baseline - 60 days | 
| Change from baseline in the International Index of Erectile Function (IIEF) score | Self reported erectile function; higher score indicates less dysfunction | Baseline - 90 days | 
| Change from baseline in the Aging Male Symptome Scale (AMS) score | Self reported symptoms; lower score indicates fewer/lesser symptoms | Baseline - 30 days | 
| Change from baseline in the Aging Male Symptome Scale (AMS) score | Self reported symptoms; lower score indicates fewer/lesser symptoms | Baseline - 60 days | 
| Change from baseline in the Aging Male Symptome Scale (AMS) score | Self reported symptoms; lower score indicates fewer/lesser symptoms | Baseline - 90 days | 
| Change from baseline in the Spielberger-Hanin anxiety test | Self-administered questionnaire; higher score indicates more anxiety | Baseline - 30 days | 
| Change from baseline in the Spielberger-Hanin anxiety test | Self-administered questionnaire; higher score indicates more anxiety | Baseline - 60 days | 
| Change from baseline in the Spielberger-Hanin anxiety test | Self-administered questionnaire; higher score indicates more anxiety | Baseline - 90 days | 
| Change from baseline in testosterone levels | Blood testosterone levels, pg/ml | Baseline - 30 days | 
| Change from baseline in testosterone levels | Blood testosterone levels, pg/ml | Baseline - 60 days | 
| Change from baseline in testosterone levels | Blood testosterone levels, pg/ml | Baseline - 90 days | 
| Change from baseline in follicle stimulating hormone (FSH) levels | Blood FSH levels, mIU/ml | Baseline - 30 days | 
| Change from baseline in follicle stimulating hormone (FSH) levels | Blood FSH levels, mIU/ml | Baseline - 60 days | 
| Change from baseline in follicle stimulating hormone (FSH) levels | Blood FSH levels, mIU/ml | Baseline - 90 days | 
| Change from baseline in luteinizing hormone (LH) levels | Blood LH levels, mIU/ml | Baseline - 30 days | 
| Change from baseline in luteinizing hormone (LH) levels | Blood LH levels, mIU/ml | Baseline - 60 days | 
| Change from baseline in luteinizing hormone (LH) levels | Blood LH levels, mIU/ml | Baseline - 90 days | 
| Change from baseline in Sex Hormone Binding Globulin (SHBG) levels | Blood SHBG levels, nmol/L | Baseline - 30 days | 
| Change from baseline in Sex Hormone Binding Globulin (SHBG) levels | Blood SHBG levels, nmol/L | Baseline - 60 days | 
| Change from baseline in Sex Hormone Binding Globulin (SHBG) levels | Blood SHBG levels, nmol/L | Baseline - 90 days | 
| Change from baseline in inhibin B levels | Blood inhibin B levels, ng/L | Baseline - 90 days | 
| Change from baseline in homocystein levels | Blood homocystein levels, umol/L | Baseline - 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Based on the results of Spielberger-Hanin anxiety test (score). | Baseline - 90 days | 
| Quality of life | Based on the results of International Index of Erectile Function (IIEF) test (score) | Baseline - 90 days | 
| Quality of life | Based on the results of Aging Male Symptoms (AMS) test (score) | Baseline - 90 days | 
| Positive dynamics of the primary endpoints | Percent of patients corresponding to the primary endpoints with positive dynamics | 30th, 60th, 90th days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Succinates, Dietary supplement