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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04841395
Other study ID # 2011-KAEK-25 2019/04-18
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date December 30, 2019

Study information

Verified date April 2021
Source Bursa Yüksek Ihtisas Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Chronotype (or circadian preference) has previously been shown to be associated with sexual attitudes and behaviors and is an important factor affecting sexual satisfaction. The fact that some neurobiological variables, which are thought to have a role in ejaculation physiology, are also effective in the processes of sleep and the regulation of circadian rhythm, and evidence supporting the relationship between circadian preferences and sexual desire and sexual behavior; suggests that ejaculation disorders may be related to circadian preference. The aim of the present study was to investigate the relationship between intravaginal ejaculatory latency time (IELT), severity of disease and chronotype in lifelong PE.


Description:

After being informed about the study, all patients who gave written informed consent were questioned and diagnosed as lifelong PE according to the definition of International Society of sexual medicine (ISSM) by an experienced urologist. Since erctile dysfunction (ED) may accompany PE, the presence of ED symptoms was evaluated by the International Index of Erectile Function (IIEF-5), and those with IIEF-5 score <22 were excluded from the study. Age- and sex-matched control cases without lifelong PE were selected randomly among cases attending the hospital for a checkup procedure. A total of 114 patients with PE and 103 control subjects with similar sociodemographic characteristics were included in the study. A detailed medical and sexual history was taken, which included self-estimated intravaginal ejaculatory latency time (IELT), by an experienced sexual therapist. Moreover, Arabic Index of Premature Ejaculation (AIPE), Pittsburgh Sleep Quality Index (PSQI) and Morningness-Eveningness Questionnaire (MEQ) were administered to all participants.


Recruitment information / eligibility

Status Completed
Enrollment 217
Est. completion date December 30, 2019
Est. primary completion date August 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - male between the ages of 18-50 years, - being sexually active, and in a stable relationship with a single partner for the last 6 months - meeting diagnostic criteria of Premature ejaculation according to ISSM. Exclusion Criteria: - having a history of neurological and/or psychiatric disorders, any malignancies, sexual dysfunction other than PE, chronic systemic disease, or if they were taking alpha-blockers, phosphodiesterase type-5 inhibitors, 5-alpha reductase inhibitors, anticholinergics, antipsychotics, or antidepressants. - presence of obesity (body mass index (BMI)> 30) - presence of Erectile Dysfunction (IIEF-5 score <22)

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ)
Self-estimated intravaginal ejaculatory latency time IELT is defined as the time between the onset of vaginal intromission and the onset of intravaginal ejaculation. In the present research, self-estimated IELT duration was obtained as a result of interviews with the participants. Moreover, Arabic Index of Premature Ejaculation (AIPE), International Index of Erectile Function (IIEF-5), Pittsburgh Sleep Quality Index (PSQI) and Morningness-Eveningness Questionnaire (MEQ) were administered to all participants.

Locations

Country Name City State
Turkey Bursa Yuksek Ihtisas Training and Research Hospital Bursa

Sponsors (1)

Lead Sponsor Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Jankowski KS, Díaz-Morales JF, Randler C. Chronotype, gender, and time for sex. Chronobiol Int. 2014 Oct;31(8):911-6. doi: 10.3109/07420528.2014.925470. Epub 2014 Jun 13. — View Citation

Jocz P, Stolarski M, Jankowski KS. Similarity in Chronotype and Preferred Time for Sex and Its Role in Relationship Quality and Sexual Satisfaction. Front Psychol. 2018 Apr 4;9:443. doi: 10.3389/fpsyg.2018.00443. eCollection 2018. — View Citation

Kasaeian A, Weidenauer C, Hautzinger M, Randler C. Reproductive Success, Relationship Orientation, and Sexual Behavior in Heterosexuals: Relationship With Chronotype, Sleep, and Sex. Evol Psychol. 2019 Jul-Sep;17(3):1474704919859760. doi: 10.1177/1474704919859760. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary MEQ scores MEQ is a measurement tool developed to measure the morning and evening sleep cycle associated with circadian rhythm (Horne & Östberg, 1976). It consists of 19 self-reported likert-type items and has a rating range from 16 to 86. Higher scores in the MEQ refer to morningness chronotype, and lower scores refer to eveningness chronotype. In the Turkish adaptation study of MEQ, three different categories of circadian rhythm were defined as; 59-86 points "morningness type", 42-58 points "intermediate type", 16-41 points "eveningness type" Baseline
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