Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Potensa, a succinate-based dietary supplement
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Succinates, Dietary supplement
Eligibility Criteria
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.
Sites / Locations
- N.A. Lopatkin Urology and Interventional Radiology Research Center
- Ryazan State Medical University named after academician I.P. Pavlov
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Potensa
Placebo
Arm Description
succinate-based dietary supplement
placebo
Outcomes
Primary Outcome Measures
Change from baseline in the International Index of Erectile Function (IIEF) score
Self reported erectile function; higher score indicates less dysfunction
Change from baseline in the International Index of Erectile Function (IIEF) score
Self reported erectile function; higher score indicates less dysfunction
Change from baseline in the International Index of Erectile Function (IIEF) score
Self reported erectile function; higher score indicates less dysfunction
Change from baseline in the Aging Male Symptome Scale (AMS) score
Self reported symptoms; lower score indicates fewer/lesser symptoms
Change from baseline in the Aging Male Symptome Scale (AMS) score
Self reported symptoms; lower score indicates fewer/lesser symptoms
Change from baseline in the Aging Male Symptome Scale (AMS) score
Self reported symptoms; lower score indicates fewer/lesser symptoms
Change from baseline in the Spielberger-Hanin anxiety test
Self-administered questionnaire; higher score indicates more anxiety
Change from baseline in the Spielberger-Hanin anxiety test
Self-administered questionnaire; higher score indicates more anxiety
Change from baseline in the Spielberger-Hanin anxiety test
Self-administered questionnaire; higher score indicates more anxiety
Change from baseline in testosterone levels
Blood testosterone levels, pg/ml
Change from baseline in testosterone levels
Blood testosterone levels, pg/ml
Change from baseline in testosterone levels
Blood testosterone levels, pg/ml
Change from baseline in follicle stimulating hormone (FSH) levels
Blood FSH levels, mIU/ml
Change from baseline in follicle stimulating hormone (FSH) levels
Blood FSH levels, mIU/ml
Change from baseline in follicle stimulating hormone (FSH) levels
Blood FSH levels, mIU/ml
Change from baseline in luteinizing hormone (LH) levels
Blood LH levels, mIU/ml
Change from baseline in luteinizing hormone (LH) levels
Blood LH levels, mIU/ml
Change from baseline in luteinizing hormone (LH) levels
Blood LH levels, mIU/ml
Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
Blood SHBG levels, nmol/L
Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
Blood SHBG levels, nmol/L
Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
Blood SHBG levels, nmol/L
Change from baseline in inhibin B levels
Blood inhibin B levels, ng/L
Change from baseline in homocystein levels
Blood homocystein levels, umol/L
Secondary Outcome Measures
Quality of life
Based on the results of Spielberger-Hanin anxiety test (score).
Quality of life
Based on the results of International Index of Erectile Function (IIEF) test (score)
Quality of life
Based on the results of Aging Male Symptoms (AMS) test (score)
Positive dynamics of the primary endpoints
Percent of patients corresponding to the primary endpoints with positive dynamics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03039504
Brief Title
Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction
Official Title
Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
June 28, 2017 (Actual)
Study Completion Date
June 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Center, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Succinates, Dietary supplement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Potensa
Arm Type
Experimental
Arm Description
succinate-based dietary supplement
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Potensa, a succinate-based dietary supplement
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in the International Index of Erectile Function (IIEF) score
Description
Self reported erectile function; higher score indicates less dysfunction
Time Frame
Baseline - 30 days
Title
Change from baseline in the International Index of Erectile Function (IIEF) score
Description
Self reported erectile function; higher score indicates less dysfunction
Time Frame
Baseline - 60 days
Title
Change from baseline in the International Index of Erectile Function (IIEF) score
Description
Self reported erectile function; higher score indicates less dysfunction
Time Frame
Baseline - 90 days
Title
Change from baseline in the Aging Male Symptome Scale (AMS) score
Description
Self reported symptoms; lower score indicates fewer/lesser symptoms
Time Frame
Baseline - 30 days
Title
Change from baseline in the Aging Male Symptome Scale (AMS) score
Description
Self reported symptoms; lower score indicates fewer/lesser symptoms
Time Frame
Baseline - 60 days
Title
Change from baseline in the Aging Male Symptome Scale (AMS) score
Description
Self reported symptoms; lower score indicates fewer/lesser symptoms
Time Frame
Baseline - 90 days
Title
Change from baseline in the Spielberger-Hanin anxiety test
Description
Self-administered questionnaire; higher score indicates more anxiety
Time Frame
Baseline - 30 days
Title
Change from baseline in the Spielberger-Hanin anxiety test
Description
Self-administered questionnaire; higher score indicates more anxiety
Time Frame
Baseline - 60 days
Title
Change from baseline in the Spielberger-Hanin anxiety test
Description
Self-administered questionnaire; higher score indicates more anxiety
Time Frame
Baseline - 90 days
Title
Change from baseline in testosterone levels
Description
Blood testosterone levels, pg/ml
Time Frame
Baseline - 30 days
Title
Change from baseline in testosterone levels
Description
Blood testosterone levels, pg/ml
Time Frame
Baseline - 60 days
Title
Change from baseline in testosterone levels
Description
Blood testosterone levels, pg/ml
Time Frame
Baseline - 90 days
Title
Change from baseline in follicle stimulating hormone (FSH) levels
Description
Blood FSH levels, mIU/ml
Time Frame
Baseline - 30 days
Title
Change from baseline in follicle stimulating hormone (FSH) levels
Description
Blood FSH levels, mIU/ml
Time Frame
Baseline - 60 days
Title
Change from baseline in follicle stimulating hormone (FSH) levels
Description
Blood FSH levels, mIU/ml
Time Frame
Baseline - 90 days
Title
Change from baseline in luteinizing hormone (LH) levels
Description
Blood LH levels, mIU/ml
Time Frame
Baseline - 30 days
Title
Change from baseline in luteinizing hormone (LH) levels
Description
Blood LH levels, mIU/ml
Time Frame
Baseline - 60 days
Title
Change from baseline in luteinizing hormone (LH) levels
Description
Blood LH levels, mIU/ml
Time Frame
Baseline - 90 days
Title
Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
Description
Blood SHBG levels, nmol/L
Time Frame
Baseline - 30 days
Title
Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
Description
Blood SHBG levels, nmol/L
Time Frame
Baseline - 60 days
Title
Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
Description
Blood SHBG levels, nmol/L
Time Frame
Baseline - 90 days
Title
Change from baseline in inhibin B levels
Description
Blood inhibin B levels, ng/L
Time Frame
Baseline - 90 days
Title
Change from baseline in homocystein levels
Description
Blood homocystein levels, umol/L
Time Frame
Baseline - 90 days
Secondary Outcome Measure Information:
Title
Quality of life
Description
Based on the results of Spielberger-Hanin anxiety test (score).
Time Frame
Baseline - 90 days
Title
Quality of life
Description
Based on the results of International Index of Erectile Function (IIEF) test (score)
Time Frame
Baseline - 90 days
Title
Quality of life
Description
Based on the results of Aging Male Symptoms (AMS) test (score)
Time Frame
Baseline - 90 days
Title
Positive dynamics of the primary endpoints
Description
Percent of patients corresponding to the primary endpoints with positive dynamics
Time Frame
30th, 60th, 90th days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgenii A Efremov, MD
Organizational Affiliation
N.A. Lopatkin Urology and Interventional Radiology Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
N.A. Lopatkin Urology and Interventional Radiology Research Center
City
Moscow
ZIP/Postal Code
105425
Country
Russian Federation
Facility Name
Ryazan State Medical University named after academician I.P. Pavlov
City
Ryazan'
ZIP/Postal Code
390026
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction
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