UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054623 |
|---|---|
| Receipt number | R000062415 |
| Scientific Title | The effect of different doses of paroxetine in premature ejaculation: a prospective randomized cross-over clinical trial |
| Date of disclosure of the study information | 2024/06/11 |
| Last modified on | 2024/06/11 01:02:35 |
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Basic information
Public title
The effect of different doses of paroxetine in premature ejaculation: a prospective randomized cross-over clinical trial
Acronym
The effect of different doses of paroxetine in premature ejaculation: a prospective randomized cross-over clinical trial
Scientific Title
The effect of different doses of paroxetine in premature ejaculation: a prospective randomized cross-over clinical trial
Scientific Title:Acronym
The effect of different doses of paroxetine in premature ejaculation: a prospective randomized cross-over clinical trial
Region
| Africa |
Condition
Condition
male sexual dysfunction
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluating the effect of different doses of Paroxetine in premature ejaculation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluating the effect of different doses of Paroxetine in premature ejaculation
Key secondary outcomes
safety profile and complications of different doses of Paroxetine in premature ejaculation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
group 1 will receive 12.5 mg paroxetine daily for 2 months then gradual tapering for 2 weeks then a 2 week washout period
Interventions/Control_2
group 2 will receive 20 mg paroxetine daily for 2 months then gradual tapering for 2 weeks then a 2 week washout period
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
The patients married for at least 1 year with stable and continuous marital relationship. They will be asked not to use condoms, topical anaesthetic cream or spray before sexual intercourse. They will be presented with lifelong PE (intravaginal latency time <2 min) and inability to satisfy their partners. None of them had any formal psychosexual counselling.
Key exclusion criteria
Patients with erectile dysfunction (men having International Index of Erectile Function (IIEF) score (validated Arabic version) <21), reduced sexual desire or inhibited male orgasm were excluded from the study. In addition, patients with presence of mental disorders, physical illnesses affecting ejaculatory function, abuse of alcohol or recreational drugs and any psychotropic medications that may affect response to SSRIs or any medical treatment for premature ejaculation in the past 6 months were also excluded. Also, patients with urinary tract infection will be excluded.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Sameh |
| Middle name | Fayek |
| Last name | GamalEl Din |
Organization
Kasr alainy cairo university
Division name
Andrology & STDs
Zip code
002
Address
South academy, New cairo, Cairo
TEL
002025729584
samehfayek@kasralainy.edu.eg
Public contact
Name of contact person
| 1st name | Sameh |
| Middle name | Fayek |
| Last name | GamalEl Din |
Organization
Cairo University
Division name
Andrology & STDs
Zip code
002
Address
South academy, New cairo, Cairo
TEL
0020729584
Homepage URL
http://scholar.cu.edu.eg/sfayek
samehfayek@kasralainy.edu.eg
Sponsor or person
Institute
Kasr alainy cairo university
Institute
Department
Personal name
sameh fayek gamalEl Din
Funding Source
Organization
Kasr alainy cairo university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kasr alainy cairo university
Address
South academy, New cairo, Cairo
Tel
0020 25 729 584
samehfayek@kasralainy.edu.eg
Secondary IDs
Secondary IDs
YES
Study ID_1
sameh fayek gamalel din
Org. issuing International ID_1
Kasr alainy cairo university
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 17 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 17 | Day |
Date analysis concluded
| 2025 | Year | 06 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 11 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062415
