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

R

Research Center, LLC

Status

Completed

Conditions

Erectile Dysfunction

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Potensa, a succinate-based dietary supplement

Study type

Interventional

Funder types

Industry

Identifiers

NCT03039504
Potensa02-2017

Details and patient eligibility

About

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.

Enrollment

106 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

106 participants in 2 patient groups, including a placebo group

Potensa
Experimental group
Description:
succinate-based dietary supplement
Treatment:
Dietary Supplement: Potensa, a succinate-based dietary supplement
Placebo
Placebo Comparator group
Description:
placebo
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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