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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039504
• Other study ID #: Potensa02-2017
• Status: Completed
• Phase: N/A
• First received: January 23, 2017
• Last updated: June 30, 2017
• Start date: January 31, 2017
• Est. completion date: June 28, 2017

Study information

• Verified date: June 2017
• Source: Research Center, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 28, 2017
• Est. primary completion date: June 28, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Dietary Supplement:
• Potensa, 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.
• Placebo
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.

Locations

Country	Name	City	State
Russian Federation	N.A. Lopatkin Urology and Interventional Radiology Research Center	Moscow
Russian Federation	Ryazan State Medical University named after academician I.P. Pavlov	Ryazan'

Sponsors (1)

Lead Sponsor	Collaborator
Research Center, LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the International Index of Erectile Function (IIEF) score	Self reported erectile function; higher score indicates less dysfunction	Baseline - 30 days
Primary	Change from baseline in the International Index of Erectile Function (IIEF) score	Self reported erectile function; higher score indicates less dysfunction	Baseline - 60 days
Primary	Change from baseline in the International Index of Erectile Function (IIEF) score	Self reported erectile function; higher score indicates less dysfunction	Baseline - 90 days
Primary	Change from baseline in the Aging Male Symptome Scale (AMS) score	Self reported symptoms; lower score indicates fewer/lesser symptoms	Baseline - 30 days
Primary	Change from baseline in the Aging Male Symptome Scale (AMS) score	Self reported symptoms; lower score indicates fewer/lesser symptoms	Baseline - 60 days
Primary	Change from baseline in the Aging Male Symptome Scale (AMS) score	Self reported symptoms; lower score indicates fewer/lesser symptoms	Baseline - 90 days
Primary	Change from baseline in the Spielberger-Hanin anxiety test	Self-administered questionnaire; higher score indicates more anxiety	Baseline - 30 days
Primary	Change from baseline in the Spielberger-Hanin anxiety test	Self-administered questionnaire; higher score indicates more anxiety	Baseline - 60 days
Primary	Change from baseline in the Spielberger-Hanin anxiety test	Self-administered questionnaire; higher score indicates more anxiety	Baseline - 90 days
Primary	Change from baseline in testosterone levels	Blood testosterone levels, pg/ml	Baseline - 30 days
Primary	Change from baseline in testosterone levels	Blood testosterone levels, pg/ml	Baseline - 60 days
Primary	Change from baseline in testosterone levels	Blood testosterone levels, pg/ml	Baseline - 90 days
Primary	Change from baseline in follicle stimulating hormone (FSH) levels	Blood FSH levels, mIU/ml	Baseline - 30 days
Primary	Change from baseline in follicle stimulating hormone (FSH) levels	Blood FSH levels, mIU/ml	Baseline - 60 days
Primary	Change from baseline in follicle stimulating hormone (FSH) levels	Blood FSH levels, mIU/ml	Baseline - 90 days
Primary	Change from baseline in luteinizing hormone (LH) levels	Blood LH levels, mIU/ml	Baseline - 30 days
Primary	Change from baseline in luteinizing hormone (LH) levels	Blood LH levels, mIU/ml	Baseline - 60 days
Primary	Change from baseline in luteinizing hormone (LH) levels	Blood LH levels, mIU/ml	Baseline - 90 days
Primary	Change from baseline in Sex Hormone Binding Globulin (SHBG) levels	Blood SHBG levels, nmol/L	Baseline - 30 days
Primary	Change from baseline in Sex Hormone Binding Globulin (SHBG) levels	Blood SHBG levels, nmol/L	Baseline - 60 days
Primary	Change from baseline in Sex Hormone Binding Globulin (SHBG) levels	Blood SHBG levels, nmol/L	Baseline - 90 days
Primary	Change from baseline in inhibin B levels	Blood inhibin B levels, ng/L	Baseline - 90 days
Primary	Change from baseline in homocystein levels	Blood homocystein levels, umol/L	Baseline - 90 days
Secondary	Quality of life	Based on the results of Spielberger-Hanin anxiety test (score).	Baseline - 90 days
Secondary	Quality of life	Based on the results of International Index of Erectile Function (IIEF) test (score)	Baseline - 90 days
Secondary	Quality of life	Based on the results of Aging Male Symptoms (AMS) test (score)	Baseline - 90 days
Secondary	Positive dynamics of the primary endpoints	Percent of patients corresponding to the primary endpoints with positive dynamics	30th, 60th, 90th days