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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
Research Center, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Succinates, Dietary supplement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

First Posted
January 23, 2017
Last Updated
June 30, 2017
Sponsor
Research Center, LLC
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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

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

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