Clinical trial NCT03039504: 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
Overall status: COMPLETED
Phase: NA
Conditions: Erectile Dysfunction
Keywords: Succinates
Dietary supplement
Lead sponsor: Research Center, LLC
Sponsor class: INDUSTRY
First posted: 2017-02-01
Enrollment: 106
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline in the International Index of Erectile Function (IIEF) score
timeFrame: Baseline - 30 days
measure: Change from baseline in the International Index of Erectile Function (IIEF) score
timeFrame: Baseline - 60 days
measure: Change from baseline in the International Index of Erectile Function (IIEF) score
timeFrame: Baseline - 90 days
measure: Change from baseline in the Aging Male Symptome Scale (AMS) score
timeFrame: Baseline - 30 days
measure: Change from baseline in the Aging Male Symptome Scale (AMS) score
timeFrame: Baseline - 60 days
measure: Change from baseline in the Aging Male Symptome Scale (AMS) score
timeFrame: Baseline - 90 days
measure: Change from baseline in the Spielberger-Hanin anxiety test
timeFrame: Baseline - 30 days
measure: Change from baseline in the Spielberger-Hanin anxiety test
timeFrame: Baseline - 60 days
measure: Change from baseline in the Spielberger-Hanin anxiety test
timeFrame: Baseline - 90 days
measure: Change from baseline in testosterone levels
timeFrame: Baseline - 30 days
measure: Change from baseline in testosterone levels
timeFrame: Baseline - 60 days
measure: Change from baseline in testosterone levels
timeFrame: Baseline - 90 days
measure: Change from baseline in follicle stimulating hormone (FSH) levels
timeFrame: Baseline - 30 days
measure: Change from baseline in follicle stimulating hormone (FSH) levels
timeFrame: Baseline - 60 days
measure: Change from baseline in follicle stimulating hormone (FSH) levels
timeFrame: Baseline - 90 days
measure: Change from baseline in luteinizing hormone (LH) levels
timeFrame: Baseline - 30 days
measure: Change from baseline in luteinizing hormone (LH) levels
timeFrame: Baseline - 60 days
measure: Change from baseline in luteinizing hormone (LH) levels
timeFrame: Baseline - 90 days
measure: Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
timeFrame: Baseline - 30 days
measure: Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
timeFrame: Baseline - 60 days
measure: Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
timeFrame: Baseline - 90 days
measure: Change from baseline in inhibin B levels
timeFrame: Baseline - 90 days
measure: Change from baseline in homocystein levels
timeFrame: Baseline - 90 days
Secondary outcomes:
measure: Quality of life
timeFrame: Baseline - 90 days
measure: Quality of life
timeFrame: Baseline - 90 days
measure: Quality of life
timeFrame: Baseline - 90 days
measure: Positive dynamics of the primary endpoints
timeFrame: 30th, 60th, 90th days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: N.A. Lopatkin Urology and Interventional Radiology Research Center
city: Ryazan'
country: Russian Federation
facility: Ryazan State Medical University named after academician I.P. Pavlov
Study officials:
affiliation: N.A. Lopatkin Urology and Interventional Radiology Research Center
name: Evgenii A Efremov, MD
role: PRINCIPAL_INVESTIGATOR
References: