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

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Dietary supplement: Potensa, a succinate-based dietary supplement; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 105425
    • N.A. Lopatkin Urology and Interventional Radiology Research Center
  • Ryazan', Russian Federation, 390026
    • Ryazan State Medical University named after academician I.P. Pavlov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; placebo	Dietary supplement: Placebo; 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.
Experimental: Potensa; succinate-based dietary supplement	Dietary supplement: Potensa, a succinate-based 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Research Center, LLC
• Investigators: Principal Investigator: Evgenii A Efremov, MD, N.A. Lopatkin Urology and Interventional Radiology Research Center

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2017
• Primary Completion (Actual): June 28, 2017
• Study Completion (Actual): June 28, 2017

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Dietary supplement; Succinates
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: Potensa02-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No