Effects of Tadalafil on LMR and MHR in Patients With ED

NCT ID: NCT03918993

Last Updated: 2019-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-14

Study Completion Date

2019-04-05

Brief Summary

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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.

Detailed Description

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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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Conditions

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Erectile Dysfunction Inflammation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group T

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

Tadalafil 5mg tablet

Intervention Type DRUG

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

Group C

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

No interventions assigned to this group

Interventions

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Tadalafil 5mg tablet

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

Intervention Type DRUG

Other Intervention Names

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phosphodiesterase type 5 (PDE5) inhibitor

Eligibility Criteria

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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
Minimum Eligible Age

39 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role collaborator

Samsun Liv Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Necmettin Mercimek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yakup Bostancı, MD

Role: STUDY_CHAIR

Ondokuz Mayıs University

Locations

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Samsun Liv Hospital

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 21911624 (View on PubMed)

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.

Reference Type RESULT
PMID: 29145685 (View on PubMed)

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.

Reference Type RESULT
PMID: 30777468 (View on PubMed)

Other Identifiers

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OMU KAEK 2019/158

Identifier Type: -

Identifier Source: org_study_id

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