Skip to main content
OpenTrials
Completed

NCT Number: NCT03039504

Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

N.A. Lopatkin Urology and Interventional Radiology Research Center, Moscow, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Potensa, a succinate-based dietary supplement

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.

Placebo

Dietary 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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Change from baseline in the Spielberger-Hanin anxiety test

    Time frame: Baseline - 30 days

    Self-administered questionnaire; higher score indicates more anxiety

  8. Change from baseline in the Spielberger-Hanin anxiety test

    Time frame: Baseline - 60 days

    Self-administered questionnaire; higher score indicates more anxiety

  9. Change from baseline in the Spielberger-Hanin anxiety test

    Time frame: Baseline - 90 days

    Self-administered questionnaire; higher score indicates more anxiety

  10. Change from baseline in testosterone levels

    Time frame: Baseline - 30 days

    Blood testosterone levels, pg/ml

  11. Change from baseline in testosterone levels

    Time frame: Baseline - 60 days

    Blood testosterone levels, pg/ml

  12. Change from baseline in testosterone levels

    Time frame: Baseline - 90 days

    Blood testosterone levels, pg/ml

  13. Change from baseline in follicle stimulating hormone (FSH) levels

    Time frame: Baseline - 30 days

    Blood FSH levels, mIU/ml

  14. Change from baseline in follicle stimulating hormone (FSH) levels

    Time frame: Baseline - 60 days

    Blood FSH levels, mIU/ml

  15. Change from baseline in follicle stimulating hormone (FSH) levels

    Time frame: Baseline - 90 days

    Blood FSH levels, mIU/ml

  16. Change from baseline in luteinizing hormone (LH) levels

    Time frame: Baseline - 30 days

    Blood LH levels, mIU/ml

  17. Change from baseline in luteinizing hormone (LH) levels

    Time frame: Baseline - 60 days

    Blood LH levels, mIU/ml

  18. Change from baseline in luteinizing hormone (LH) levels

    Time frame: Baseline - 90 days

    Blood LH levels, mIU/ml

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

    Time frame: Baseline - 30 days

    Blood SHBG levels, nmol/L

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

    Time frame: Baseline - 60 days

    Blood SHBG levels, nmol/L

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

    Time frame: Baseline - 90 days

    Blood SHBG levels, nmol/L

  22. Change from baseline in inhibin B levels

    Time frame: Baseline - 90 days

    Blood inhibin B levels, ng/L

  23. Change from baseline in homocystein levels

    Time frame: Baseline - 90 days

    Blood homocystein levels, umol/L

Secondary outcomes

  1. Quality of life

    Time frame: Baseline - 90 days

    Based on the results of Spielberger-Hanin anxiety test (score).

  2. Quality of life

    Time frame: Baseline - 90 days

    Based on the results of International Index of Erectile Function (IIEF) test (score)

  3. Quality of life

    Time frame: Baseline - 90 days

    Based on the results of Aging Male Symptoms (AMS) test (score)

  4. Positive dynamics of the primary endpoints

    Time frame: 30th, 60th, 90th days

    Percent of patients corresponding to the primary endpoints with positive dynamics

Sponsors and collaborators

Lead sponsor

Research Center, LLC

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 1, 2017
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.