NCT03039504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

January 31, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

January 23, 2017

Last Update Submit

June 30, 2017

Conditions

Erectile Dysfunction

Keywords

SuccinatesDietary supplement

Outcome Measures

Primary Outcomes (23)

  • Change from baseline in the International Index of Erectile Function (IIEF) score

    Self reported erectile function; higher score indicates less dysfunction

    Baseline - 30 days

  • Change from baseline in the International Index of Erectile Function (IIEF) score

    Self reported erectile function; higher score indicates less dysfunction

    Baseline - 60 days

  • Change from baseline in the International Index of Erectile Function (IIEF) score

    Self reported erectile function; higher score indicates less dysfunction

    Baseline - 90 days

  • Change from baseline in the Aging Male Symptome Scale (AMS) score

    Self reported symptoms; lower score indicates fewer/lesser symptoms

    Baseline - 30 days

  • Change from baseline in the Aging Male Symptome Scale (AMS) score

    Self reported symptoms; lower score indicates fewer/lesser symptoms

    Baseline - 60 days

  • Change from baseline in the Aging Male Symptome Scale (AMS) score

    Self reported symptoms; lower score indicates fewer/lesser symptoms

    Baseline - 90 days

  • Change from baseline in the Spielberger-Hanin anxiety test

    Self-administered questionnaire; higher score indicates more anxiety

    Baseline - 30 days

  • Change from baseline in the Spielberger-Hanin anxiety test

    Self-administered questionnaire; higher score indicates more anxiety

    Baseline - 60 days

  • Change from baseline in the Spielberger-Hanin anxiety test

    Self-administered questionnaire; higher score indicates more anxiety

    Baseline - 90 days

  • Change from baseline in testosterone levels

    Blood testosterone levels, pg/ml

    Baseline - 30 days

  • Change from baseline in testosterone levels

    Blood testosterone levels, pg/ml

    Baseline - 60 days

  • Change from baseline in testosterone levels

    Blood testosterone levels, pg/ml

    Baseline - 90 days

  • Change from baseline in follicle stimulating hormone (FSH) levels

    Blood FSH levels, mIU/ml

    Baseline - 30 days

  • Change from baseline in follicle stimulating hormone (FSH) levels

    Blood FSH levels, mIU/ml

    Baseline - 60 days

  • Change from baseline in follicle stimulating hormone (FSH) levels

    Blood FSH levels, mIU/ml

    Baseline - 90 days

  • Change from baseline in luteinizing hormone (LH) levels

    Blood LH levels, mIU/ml

    Baseline - 30 days

  • Change from baseline in luteinizing hormone (LH) levels

    Blood LH levels, mIU/ml

    Baseline - 60 days

  • Change from baseline in luteinizing hormone (LH) levels

    Blood LH levels, mIU/ml

    Baseline - 90 days

  • Change from baseline in Sex Hormone Binding Globulin (SHBG) levels

    Blood SHBG levels, nmol/L

    Baseline - 30 days

  • Change from baseline in Sex Hormone Binding Globulin (SHBG) levels

    Blood SHBG levels, nmol/L

    Baseline - 60 days

  • Change from baseline in Sex Hormone Binding Globulin (SHBG) levels

    Blood SHBG levels, nmol/L

    Baseline - 90 days

  • Change from baseline in inhibin B levels

    Blood inhibin B levels, ng/L

    Baseline - 90 days

  • Change from baseline in homocystein levels

    Blood homocystein levels, umol/L

    Baseline - 90 days

Secondary Outcomes (4)

  • Quality of life

    Baseline - 90 days

  • Quality of life

    Baseline - 90 days

  • Quality of life

    Baseline - 90 days

  • Positive dynamics of the primary endpoints

    30th, 60th, 90th days

Study Arms (2)

Potensa

EXPERIMENTAL

succinate-based dietary supplement

Dietary Supplement: Potensa, a succinate-based dietary supplement

Placebo

PLACEBO COMPARATOR

placebo

Dietary Supplement: Placebo

Interventions

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.

Potensa
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.

Placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

N.A. Lopatkin Urology and Interventional Radiology Research Center

Moscow, 105425, Russia

Location

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

Ryazan, 390026, Russia

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Evgenii A Efremov, MD

    N.A. Lopatkin Urology and Interventional Radiology Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2017

First Posted

February 1, 2017

Study Start

January 31, 2017

Primary Completion

June 28, 2017

Study Completion

June 28, 2017

Last Updated

July 2, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

RU(2)