Erectile DysfunctionNCT03039504
Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction
A study testing Potensa, a succinate-based dietary supplement in people with Erectile Dysfunction, run by Research Center, LLC at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Potensa, a succinate-based dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 2 sitesRussia
- Study dates
- 31 Jan 2017to 28 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
N.A. Lopatkin Urology and Interventional Radiology Research Center
Moscow, 105425
Ryazan State Medical University named after academician I.P. Pavlov
Ryazan, 390026
About this study
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
- Being tested
- Potensa, a succinate-based dietary supplement, Placebo
- Keywords
- Succinates, Dietary supplement
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potensa, a succinate-based dietary supplementDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Potensa | Experimental | succinate-based dietary supplement Receives: Dietary Supplement: Potensa, a succinate-based dietary supplement |
| Placebo | Placebo comparator | placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the International Index of Erectile Function (IIEF) score
Self reported erectile function; higher score indicates less dysfunction
Measured: Baseline - 30 days
Change from baseline in the International Index of Erectile Function (IIEF) score
Self reported erectile function; higher score indicates less dysfunction
Measured: Baseline - 60 days
Change from baseline in the International Index of Erectile Function (IIEF) score
Self reported erectile function; higher score indicates less dysfunction
Measured: Baseline - 90 days
Change from baseline in the Aging Male Symptome Scale (AMS) score
Self reported symptoms; lower score indicates fewer/lesser symptoms
Measured: Baseline - 30 days
Change from baseline in the Aging Male Symptome Scale (AMS) score
Self reported symptoms; lower score indicates fewer/lesser symptoms
Measured: Baseline - 60 days
Change from baseline in the Aging Male Symptome Scale (AMS) score
Self reported symptoms; lower score indicates fewer/lesser symptoms
Measured: Baseline - 90 days
Change from baseline in the Spielberger-Hanin anxiety test
Self-administered questionnaire; higher score indicates more anxiety
Measured: Baseline - 30 days
Change from baseline in the Spielberger-Hanin anxiety test
Self-administered questionnaire; higher score indicates more anxiety
Measured: Baseline - 60 days
Change from baseline in the Spielberger-Hanin anxiety test
Self-administered questionnaire; higher score indicates more anxiety
Measured: Baseline - 90 days
Change from baseline in testosterone levels
Blood testosterone levels, pg/ml
Measured: Baseline - 30 days
Change from baseline in testosterone levels
Blood testosterone levels, pg/ml
Measured: Baseline - 60 days
Change from baseline in testosterone levels
Blood testosterone levels, pg/ml
Measured: Baseline - 90 days
Change from baseline in follicle stimulating hormone (FSH) levels
Blood FSH levels, mIU/ml
Measured: Baseline - 30 days
Change from baseline in follicle stimulating hormone (FSH) levels
Blood FSH levels, mIU/ml
Measured: Baseline - 60 days
Change from baseline in follicle stimulating hormone (FSH) levels
Blood FSH levels, mIU/ml
Measured: Baseline - 90 days
Change from baseline in luteinizing hormone (LH) levels
Blood LH levels, mIU/ml
Measured: Baseline - 30 days
Change from baseline in luteinizing hormone (LH) levels
Blood LH levels, mIU/ml
Measured: Baseline - 60 days
Change from baseline in luteinizing hormone (LH) levels
Blood LH levels, mIU/ml
Measured: Baseline - 90 days
Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
Blood SHBG levels, nmol/L
Measured: Baseline - 30 days
Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
Blood SHBG levels, nmol/L
Measured: Baseline - 60 days
Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
Blood SHBG levels, nmol/L
Measured: Baseline - 90 days
Change from baseline in inhibin B levels
Blood inhibin B levels, ng/L
Measured: Baseline - 90 days
Change from baseline in homocystein levels
Blood homocystein levels, umol/L
Measured: Baseline - 90 days
Secondary outcomes (4)
Quality of life
Based on the results of Spielberger-Hanin anxiety test (score).
Measured: Baseline - 90 days
Quality of life
Based on the results of International Index of Erectile Function (IIEF) test (score)
Measured: Baseline - 90 days
Quality of life
Based on the results of Aging Male Symptoms (AMS) test (score)
Measured: Baseline - 90 days
Positive dynamics of the primary endpoints
Percent of patients corresponding to the primary endpoints with positive dynamics
Measured: 30th, 60th, 90th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start31 Jan 2017
- Primary completion28 Jun 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Center, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Evgenii A Efremov, MD, Principal investigator, N.A. Lopatkin Urology and Interventional Radiology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039504
- Sponsor's protocol ID
- Potensa02-2017
- Status last verified
- Jun 2017
- First submitted
- 23 Jan 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT03039504
- Acronym / sponsor ID
- Potensa02-2017
- Conditions
- Erectile Dysfunction
- Keywords
- Succinates, Dietary supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Research Center, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potensa | Experimental | Dietary Supplement: Potensa, a succinate-based dietary supplementsuccinate-based dietary supplement |
| Placebo | Placebo comparator | Dietary Supplement: Placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potensa, a succinate-based dietary supplementPotensa - 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 supplement | Potensa |
| PlaceboPlacebo: 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 supplement | Placebo |
Primary outcome
Change from baseline in the International Index of Erectile Function (IIEF) score
Time frame: Baseline - 30 days
Self reported erectile function; higher score indicates less dysfunction
Change from baseline in the International Index of Erectile Function (IIEF) score
Time frame: Baseline - 60 days
Self reported erectile function; higher score indicates less dysfunction
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 the Aging Male Symptome Scale (AMS) score
Time frame: Baseline - 30 days
Self reported symptoms; lower score indicates fewer/lesser symptoms
Change from baseline in the Aging Male Symptome Scale (AMS) score
Time frame: Baseline - 60 days
Self reported symptoms; lower score indicates fewer/lesser symptoms
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 - 30 days
Self-administered questionnaire; higher score indicates more anxiety
Change from baseline in the Spielberger-Hanin anxiety test
Time frame: Baseline - 60 days
Self-administered questionnaire; higher score indicates more anxiety
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 testosterone levels
Time frame: Baseline - 30 days
Blood testosterone levels, pg/ml
Change from baseline in testosterone levels
Time frame: Baseline - 60 days
Blood testosterone levels, pg/ml
Change from baseline in testosterone levels
Time frame: Baseline - 90 days
Blood testosterone levels, pg/ml
Change from baseline in follicle stimulating hormone (FSH) levels
Time frame: Baseline - 30 days
Blood FSH levels, mIU/ml
Change from baseline in follicle stimulating hormone (FSH) levels
Time frame: Baseline - 60 days
Blood FSH levels, mIU/ml
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 - 30 days
Blood LH levels, mIU/ml
Change from baseline in luteinizing hormone (LH) levels
Time frame: Baseline - 60 days
Blood LH 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 - 30 days
Blood SHBG levels, nmol/L
Change from baseline in Sex Hormone Binding Globulin (SHBG) levels
Time frame: Baseline - 60 days
Blood SHBG levels, nmol/L
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
4 secondary outcomes
Quality of life
Time frame: Baseline - 90 days
Quality of life
Time frame: Baseline - 90 days
Quality of life
Time frame: Baseline - 90 days
Positive dynamics of the primary endpoints
Time frame: 30th, 60th, 90th days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evgenii A Efremov, MD principal investigator
N.A. Lopatkin Urology and Interventional Radiology Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Potensa, a succinate-based dietary supplement in people with Erectile Dysfunction, run by Research Center, LLC at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the International Index of Erectile Function (IIEF) score (time frame: Baseline - 30 days). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.