UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the link between Dopamine Transporter Gene Polymorphisms and Response To Paroxetin and Escitalopram in Patients With Lifelong Premature Ejaculation
Title of the study (Brief title)	Dopamine transporter gene polymorphisms and SSRIs
Region	Africa

Condition
Condition	lifelong premature ejaculation
Classification by specialty	Urology Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	to assess role of dopamine gene transporter polymorphisms in lifelong premature ejaculation and their responses to selective serotonin reuptake inhibitors
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Majority of dopamine transporter gene polymorphisms majority were 10R/10R and 6R/10R
Key secondary outcomes	At the end of our study we found 27 patients out of 60 patients responded to paroxetin and escitalopram. Both of them were statistically highly significant in delaying ejaculation in the responders.Also, they demonstrated statistically highly significant relation with dopamine transporter gene polymorphism

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The patients were divided into 2 equal groups; one group was given paroxetine and the other escitalopram single dose daily for 3 months to compare efficacy of both drugs in delaying ejaculation in patients with lifelong PE. Also, to evaluate role of the studied gene polymorphisms in lifelong PE and determining response to both drugs
Interventions/Control_2	we only measured gene polymorphisms in the controls. The controls were not given medication
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	25 years-old <=
Age-upper limit	50 years-old >=
Gender	Male
Key inclusion criteria	The patients' age was between 25-50 years with a stable and continuous marital relationship for at least one year. Condoms, topical anesthetic cream or spray before sexual intercourse were prohibited, being unable to satisfy their partners with intravaginal ejaculation latency time < 1 minute since their first sexual experience on all or nearly all vaginal penetrations with negative personal consequences on him and his partner and subsequent avoidance of sexual intimacy.
Key exclusion criteria	Men suffered from ED (IIEF score< 21), reduced sexual desire or inhibited male orgasm. Also, patients with history of urinary tract infection, mental disorders and chronic physical illnesses affecting ejaculatory function, abusers of Alcohol or drug and finally, patients who received psychotropic medications that may affect response to selective serotonin reuptake inhibitors (SSRIs) or any medical treatment for premature ejaculation in the last 6 months were also excluded from the study.
Target sample size	80

Research contact person
Name of lead principal investigator	tymour khalifa Eltonsi
Organization	Al-Azhar university
Division name	andrology and dermatology
Address	Al-Azhar Street
TEL	+81-1222182039
Email	tarek_tawfik117@yahoo.com

Public contact
Name of contact person	Sameh Fayek
Organization	Cairo University
Division name	Andrology department
Address	Kasr AlAini street
TEL	+81-1227109309
Homepage URL	http://scholar.cu.edu.eg/sfayek
Email	samehfayek@hotmail.com

Sponsor
Institute	nil
Institute
Department

Funding Source
Organization	EVA and MEPACO pharmaceutical companies
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Egypt

Other related organizations
Co-sponsor	nil
Name of secondary funｄer(s)	nil

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	Al-Azhar and Cairo Universities

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 09 Month 15 Day
Anticipated trial start date	2014 Year 10 Month 27 Day
Last follow-up date	2015 Year 12 Month 01 Day
Date of closure to data entry	2015 Year 12 Month 15 Day
Date trial data considered complete	2015 Year 12 Month 15 Day
Date analysis concluded	2016 Year 01 Month 05 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Our prospective study revealed that 18 patients were LL, 42 patients were SL and SS genotypes of the serotonin transporter gene promoter polymorphism, meanwhile; the controls were 10 LL, 6 SL and 4 SS which was statistically insignificant (p-value=0.265). Thirty seven patients were 10R/10R, 17 patients were 6R/10R and 6 patients were 6R/6R genotypes of the dopamine transporter gene polymorphism, meanwhile; the controls were 15 6R/6R, 1 10R/10R and 4 6R/10R which was statistically significant (p-value=<0.001). Both paroxetin and escitalopram were highly statistically significant in delaying ejaculation in the responders (p-value=<0.001). This response was irrelevant to serotonin transporter gene promoter polymorphism (p-value= 0.275), meanwhile; such response revealed highly statistically significant relation with dopamine transporter gene polymorphism (p-value=0.019).
Other related information

Management information
Registered date	2016 Year 02 Month 01 Day
Last modified on	2017 Year 08 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024016