UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050874 |
|---|---|
| Receipt number | R000051187 |
| Scientific Title | Daily use of Duloxetine is effective in treating premature ejaculation: A prospective randomized placebo-controlled crossover clinical trial |
| Date of disclosure of the study information | 2023/04/19 |
| Last modified on | 2023/04/18 09:22:39 |
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Basic information
Public title
Daily use of Duloxetine is effective in treating premature ejaculation: A prospective randomized placebo-controlled crossover clinical trial
Acronym
Daily use of Duloxetine is effective in treating premature ejaculation: A prospective randomized placebo-controlled crossover clinical trial
Scientific Title
Daily use of Duloxetine is effective in treating premature ejaculation: A prospective randomized placebo-controlled crossover clinical trial
Scientific Title:Acronym
Daily use of Duloxetine is effective in treating premature ejaculation: A prospective randomized placebo-controlled crossover clinical trial
Region
| Africa |
Condition
Condition
male sexual function
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Daily use of Duloxetine effect in treating premature ejaculation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
improvement in premature ejaculation
Key secondary outcomes
impact on sexual function and quality of life
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
34 patients will receive duloxetine then placebo in group A
Interventions/Control_2
34 patients will receive placebo then duloxetine in group B
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
Male patients with PE (primary or secondary) with stable and committed relationship having (IELT) < 2 minutes were included
Key exclusion criteria
Patients with erectile dysfunction (ED), reduced sexual desire or inhibited male orgasm or active genitourinary tract infection (confirmed by two glasses of urine and EPS) or known mental disorders (Depression, Anxiety, Schizophrenia) or uncontrolled physical illnesses (Hepatic, Renal, Cardiac, Neurological, Endocrinal) were excluded from the study. Finally, any alcohol or drug abuser or patient with known hypersensitivity to duloxetine was excluded from the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | sameh |
| Middle name | fayek |
| Last name | gamalel din |
Organization
kasr AlAiny faculty of medicine Cairo university
Division name
Andrology & STDs
Zip code
002
Address
357 C south academy New Cairo
TEL
01227109309
samehfayek@hotmail.com
Public contact
Name of contact person
| 1st name | sameh |
| Middle name | fayek |
| Last name | gamalel din |
Organization
Kasr AlAiny faculty of medicine
Division name
Andrology & STDs
Zip code
002
Address
357 C south academy New Cairo
TEL
01227109309
Homepage URL
http://scholar.cu.edu.eg/sfayek
samehfayek@hotmail.com
Sponsor or person
Institute
Kasr AlAiny faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Kasr AlAiny faculty of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Egypt
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cairo University, Faculty of medicine, Cairo, Egypt
Address
357 C south academy New Cairo
Tel
+20 25 729 584
samehfayek@hotmail.com
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
Duloxetine is effective and safe in patients with primary and secondary premature ejaculation
Publication of results
Unpublished
Result
URL related to results and publications
Duloxetine is effective and safe in patients with primary and secondary premature ejaculation
Number of participants that the trial has enrolled
100
Results
Duloxetine is effective and safe in patients with primary and secondary premature ejaculation
Results date posted
| 2023 | Year | 04 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Duloxetine is effective and safe in patients with primary and secondary premature ejaculation
Participant flow
Duloxetine is effective and safe in patients with primary and secondary premature ejaculation
Adverse events
Nausea was the main side effect reported
Outcome measures
Duloxetine is effective and safe in patients with primary and secondary premature ejaculation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 18 | Day |
Last modified on
| 2023 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051187
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