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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potensa | Experimental | succinate-based dietary supplement |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potensa, a succinate-based dietary supplement | Dietary Supplement | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evgenii A Efremov, MD | N.A. Lopatkin Urology and Interventional Radiology Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| N.A. Lopatkin Urology and Interventional Radiology Research Center | Moscow | 105425 | Russia | |||
| Ryazan State Medical University named after academician I.P. Pavlov |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| Placebo | Dietary Supplement | 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. |
|
| 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 |
| 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 |
| Ryazan |
| 390026 |
| Russia |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |