Erectile Dysfunction
Conditions
Keywords
Succinates, Dietary supplement
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.
Interventions
DIETARY_SUPPLEMENTPotensa, 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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Research Center, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in homocystein levels | Baseline - 90 days | Blood homocystein levels, umol/L |
| Change from baseline in Sex Hormone Binding Globulin (SHBG) levels | Baseline - 30 days | Blood SHBG levels, nmol/L |
| Change from baseline in inhibin B levels | Baseline - 90 days | Blood inhibin B levels, ng/L |
| Change from baseline in the International Index of Erectile Function (IIEF) score | Baseline - 30 days | Self reported erectile function; higher score indicates less dysfunction |
| Change from baseline in the Aging Male Symptome Scale (AMS) score | Baseline - 30 days | Self reported symptoms; lower score indicates fewer/lesser symptoms |
| Change from baseline in the Spielberger-Hanin anxiety test | Baseline - 30 days | Self-administered questionnaire; higher score indicates more anxiety |
| Change from baseline in testosterone levels | Baseline - 30 days | Blood testosterone levels, pg/ml |
| Change from baseline in follicle stimulating hormone (FSH) levels | Baseline - 30 days | Blood FSH levels, mIU/ml |
| Change from baseline in luteinizing hormone (LH) levels | Baseline - 30 days | Blood LH levels, mIU/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive dynamics of the primary endpoints | 30th, 60th, 90th days | Percent of patients corresponding to the primary endpoints with positive dynamics |
| Quality of life | Baseline - 90 days | Based on the results of Spielberger-Hanin anxiety test (score). |
Countries
Russia
Outcome results
None listed