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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020816
Receipt No. R000024016
Scientific Title Study of the link between Dopamine Transporter Gene Polymorphisms and Response To Paroxetin and Escitalopram in Patients With Lifelong Premature Ejaculation
Date of disclosure of the study information 2016/02/01
Last modified on 2017/08/11

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Basic information
Public title Study of the link between Dopamine Transporter Gene Polymorphisms and Response To Paroxetin and Escitalopram in Patients With Lifelong Premature Ejaculation
Acronym Dopamine transporter gene polymorphisms and SSRIs
Scientific Title Study of the link between Dopamine Transporter Gene Polymorphisms and Response To Paroxetin and Escitalopram in Patients With Lifelong Premature Ejaculation
Scientific Title:Acronym 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
1st name
Middle name
Last name tymour khalifa Eltonsi
Organization Al-Azhar university
Division name andrology and dermatology
Zip code
Address Al-Azhar Street
TEL +81-1222182039
Email tarek_tawfik117@yahoo.com

Public contact
Name of contact person
1st name
Middle name
Last name Sameh Fayek
Organization Cairo University
Division name Andrology department
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2014 Year 09 Month 15 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
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Research case data
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