Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Erectile Dysfunction
- Sponsor
- Research Center, LLC
- Enrollment
- 106
- Locations
- 2
- Primary Endpoint
- Change from baseline in testosterone levels
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Change from baseline in testosterone levels
Time Frame: Baseline - 90 days
Blood testosterone levels, pg/ml
Change from baseline in the Aging Male Symptome Scale (AMS) score
Time Frame: Baseline - 90 days
Self reported symptoms; lower score indicates fewer/lesser symptoms
Change from baseline in the Spielberger-Hanin anxiety test
Time Frame: Baseline - 90 days
Self-administered questionnaire; higher score indicates more anxiety
Change from baseline in the International Index of Erectile Function (IIEF) score
Time Frame: Baseline - 90 days
Self reported erectile function; higher score indicates less dysfunction
Change from baseline in follicle stimulating hormone (FSH) levels
Time Frame: Baseline - 90 days
Blood FSH levels, mIU/ml
Change from baseline in luteinizing hormone (LH) levels
Time Frame: Baseline - 90 days
Blood LH levels, mIU/ml
Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
Time Frame: Baseline - 90 days
Blood SHBG levels, nmol/L
Change from baseline in inhibin B levels
Time Frame: Baseline - 90 days
Blood inhibin B levels, ng/L
Change from baseline in homocystein levels
Time Frame: Baseline - 90 days
Blood homocystein levels, umol/L
Secondary Outcomes
- Quality of life(Baseline - 90 days)
- Positive dynamics of the primary endpoints(30th, 60th, 90th days)