Effects of Tadalafil on LMR and MHR in Patients With ED

NCT03918993 | Completed DMC

• 1 other identifier: OMU KAEK 2019/158
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Erectile Dysfunction; Inflammation

Keywords

Erectile Dysfunction; lymphocyte to monocyte ratio; monocyte to HDL ratio

Outcome Measures

Primary Outcomes (8)

• Lymphocyte to Monocyte Ratio

  ratio of values in complete blood count

  up to 8 weeks

• monocyte to HDL ratio

  an inflamamtoy marker

  up to 8 weeks

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

  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

  up to 8 weeks

• monocyte count

  complete blood count

  up to 8 weeks

• lymphocyte count

  complete blood count

  up to 8 weeks

• HDL cholesterol

  serum lipid profile

  up to 8 weeks

• Testosteron

  hormonal evaluation

  up to 8 weeks

• fasting glucose

  serum glucose level

  at the 1st day

Study Arms (2)

Group T

31 Patients with ED who receiving 5 mg/day of Tadalafil for 8 weeks.

Drug: Tadalafil 5mg tablet

Group C

Thirty-one healthy men who were admitted to the internal medicine outpatient clinic for their annual follow-up

Interventions

Tadalafil 5mg tablet DRUG

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

Also known as: phosphodiesterase type 5 (PDE5) inhibitor

Group T

Eligibility Criteria

• Age: 39 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 Thirty-one male patients with organic erectile dysfunction more than one year between 39 and 65 years of age which were treated with OAD 5 mg dose of tadalafil for eight weeks were selected as the treatment group

You may qualify if:

• years old men with ED
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun Liv Hospital: lead
• Ondokuz Mayıs University: collaborator

Study Sites (1)

Samsun Liv Hospital

Samsun, 55020, Turkey (Türkiye)

Location

Related Publications (3)

• Gupta BP, Murad MH, Clifton MM, Prokop L, Nehra A, Kopecky SL. The effect of lifestyle modification and cardiovascular risk factor reduction on erectile dysfunction: a systematic review and meta-analysis. Arch Intern Med. 2011 Nov 14;171(20):1797-803. doi: 10.1001/archinternmed.2011.440. Epub 2011 Sep 12.

  PMID: 21911624 RESULT

• Kadihasanoglu M, Karabay E, Yucetas U, Erkan E, Ozbek E. Relation between Monocyte to High-Density Lipoprotein Cholesterol Ratio and Presence and Severity of Erectile Dysfunction. Aktuelle Urol. 2018 Jun;49(3):256-261. doi: 10.1055/s-0042-123163. Epub 2017 Nov 16.

  PMID: 29145685 RESULT

• Cimen S, Dursun M, Sulukaya M, Besiroglu H. Could the monocyte/HDL cholesterol ratio be an early marker of erectile dysfunction? Aging Male. 2020 Dec;23(5):694-699. doi: 10.1080/13685538.2019.1574735. Epub 2019 Feb 19.

  PMID: 30777468 RESULT

MeSH Terms

Conditions

Erectile Dysfunction; Inflammation

Interventions

Tadalafil; Tablets; Cyclic Nucleotide Phosphodiesterases, Type 5; PDE5A protein, human

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Dosage Forms; Pharmaceutical Preparations; 3',5'-Cyclic-AMP Phosphodiesterases; Phosphoric Diester Hydrolases; Esterases; Hydrolases; Enzymes; Enzymes and Coenzymes; 3',5'-Cyclic-GMP Phosphodiesterases; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Yakup Bostancı, MD

  Ondokuz Mayıs University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 18, 2019
• Study Start: February 14, 2019
• Primary Completion: March 10, 2019
• Study Completion: April 5, 2019
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)