UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020816 |
|---|---|
| Receipt number | 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 07:16:17 |
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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
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
samehfayek@hotmail.com
Sponsor or person
Institute
nil
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024016
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