Effects of Tadalafil on LMR and MHR in Patients With ED

Inflammation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03918993
• Other study ID #: OMU KAEK 2019/158
• Status: Completed
• Start date: February 14, 2019
• Est. completion date: April 5, 2019

Study information

• Verified date: April 2019
• Source: Samsun Liv Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 5, 2019
• Est. primary completion date: March 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 39 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Inflammation

Intervention

Drug:
• Tadalafil 5mg tablet
Once-a-day 5 mg dose of tadalafil for 8 weeks

Locations

Country	Name	City	State
Turkey	Samsun Liv Hospital	Samsun

Sponsors (2)

Lead Sponsor	Collaborator
Samsun Liv Hospital	Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Cimen S, Dursun M, Sulukaya M, Besiroglu H. Could the monocyte/HDL cholesterol ratio be an early marker of erectile dysfunction? Aging Male. 2019 Feb 19:1-6. doi: 10.1080/13685538.2019.1574735. [Epub ahead of print] — View Citation

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 — View Citation

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 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphocyte to Monocyte Ratio	ratio of values in complete blood count	up to 8 weeks
Primary	monocyte to HDL ratio	an inflamamtoy marker	up to 8 weeks
Primary	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
Primary	monocyte count	complete blood count	up to 8 weeks
Primary	lymphocyte count	complete blood count	up to 8 weeks
Primary	HDL cholesterol	serum lipid profile	up to 8 weeks
Primary	Testosteron	hormonal evaluation	up to 8 weeks
Primary	fasting glucose	serum glucose level	at the 1st day