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

NCT ID: NCT03039504

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-06-28

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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Potensa

succinate-based dietary supplement

Group Type: EXPERIMENTAL

Potensa, a succinate-based dietary supplement

Intervention Type: 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.

Placebo

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Research Center, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evgenii A Efremov, MD

Role: PRINCIPAL_INVESTIGATOR

N.A. Lopatkin Urology and Interventional Radiology Research Center

Locations

N.A. Lopatkin Urology and Interventional Radiology Research Center

Moscow, , Russia

Ryazan State Medical University named after academician I.P. Pavlov

Ryazan, , Russia

Countries

Russia

Other Identifiers

Potensa02-2017

Identifier Type: -

Identifier Source: org_study_id