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

Not Applicable

Completed

• Conditions: Erectile Dysfunction
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Potensa, a succinate-based dietary supplement

• Registration Number: NCT03039504
• Lead Sponsor: Research Center, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-23
• Study Start: 2017-01-31
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Status Verified: 2017-06
• Primary Completion: 2017-06-28
• Study Completion: 2017-06-28
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo
Potensa	Potensa, a succinate-based dietary supplement	succinate-based dietary supplement

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of life	Baseline - 90 days	Based on the results of Aging Male Symptoms (AMS) test (score)
Positive dynamics of the primary endpoints	30th, 60th, 90th days	Percent of patients corresponding to the primary endpoints with positive dynamics

Trial Locations

Locations (2)

Ryazan State Medical University named after academician I.P. Pavlov; 🇷🇺 Ryazan', Russian Federation

N.A. Lopatkin Urology and Interventional Radiology Research Center; 🇷🇺 Moscow, Russian Federation