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NCT Number: NCT03918993

Effects of Tadalafil on LMR and MHR in Patients With ED

The aim of the study was to investigate whether daily 5 mg tadalafil over eight weeks affects to Lymphocyte/Monocyte ratio (LMR) and Monocyte/High-Density Lipoprotein ratio (MHR) in patients with erectile dysfunction (ED).

Thirty-one patients with organic ED and 31 healthy controls between July 2017 and November 2018 were included in this retrospective study. To avoid bias, the patients were randomly selected and the controls were also incorporated consecutively. The presence of ED was determined according to the International Erectile Function Index-5 (IIEF-5). The patients and the controls were evaluated in terms of IIEF-5, complete blood count, serum biochemistry, LMR, and MHR.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Inflammation Male Urogenital Diseases Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

39 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Samsun Liv Hospital

Samsun, 55020, Turkey (Türkiye)

About this study

The medical records of the heterosexual men treated with the diagnosis of organic ED in the Urology department of a private hospital between July 2017 and October 2018 were evaluated retrospectively. The number of samples to be included in the study was determined by the help of the computer-assisted power analysis. Random sampling was performed from all cohorts of patients with ED. Thirty-one male patients between the ages of 39-65 with organic erectile dysfunction more than one year and treated with OAD 5 mg dose of tadalafil for eight weeks were selected as the treatment group (group T)The patients in group T have been assessed both before (T1) and after (T2) the treatment.

Between the ages of 39-65, thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up were selected consecutively and the control group (group C) was formed. All subjects in the control group were sexually active men with regular monogamous heterosexual relationships during the last one year.

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 39-65 years old men with ED
  • 39-65 years old, haelthy men
  • Patients that have received 5 mg tadalafil/day for 8 weeks
  • Patients with informed consent forms
  • Patients with no missing variables

Exclusion criteria

  • Patients with systemic autoimmune and inflammatory disease,
  • congestive heart failure,
  • chronic renal failure, and chronic hepatobiliary disease,
  • chronic lung disease, and thyroid dysfunction,
  • patients with acute infection,
  • patients with neurological deficits,
  • metabolic syndrome and malignancy
  • Patients with a history of prostate, penile or pelvic surgery or radiotherapy,,
  • patients receiving anticoagulant, beta-blocker, antidepressants and antipsychotics, hormonal therapy,
  • patients with alcohol and smoking

Treatment and study plan

Tadalafil 5mg tablet

Drug

Once-a-day 5 mg dose of tadalafil for 8 weeks

Other names: phosphodiesterase type 5 (PDE5) inhibitor

Primary outcomes

  1. Lymphocyte to Monocyte Ratio

    Time frame: up to 8 weeks

    ratio of values in complete blood count

  2. monocyte to HDL ratio

    Time frame: up to 8 weeks

    an inflamamtoy marker

  3. The International Index of Erectile Function (IIEF-5) Questionnaire

    Time frame: up to 8 weeks

    IIEF-5 scoring:

    The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunctio

  4. monocyte count

    Time frame: up to 8 weeks

    complete blood count

  5. lymphocyte count

    Time frame: up to 8 weeks

    complete blood count

  6. HDL cholesterol

    Time frame: up to 8 weeks

    serum lipid profile

  7. Testosteron

    Time frame: up to 8 weeks

    hormonal evaluation

  8. fasting glucose

    Time frame: at the 1st day

    serum glucose level

Sponsors and collaborators

Lead sponsor

Samsun Liv Hospital

Other

Collaborators

  • Ondokuz Mayıs University

Registry information

Official study title

Evaluation of the Effects of a Daily Dose of 5 mg of Tadalafil on Lymphocyte to Monocyte Ratio and Monocyte to High-Density Lipoprotein Ratio in Patients With Erectile Dysfunction

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2019
Registry last updated
Apr 23, 2019

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.

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