Premature EjaculationPhase 3NCT03879746
Effect of Tamsulosin on PE Compared With Paroxetine Hydrochloride
A Phase 3 study testing Tamsulosin and Paroxetine Hydrochloride in people with Premature Ejaculation, run by Assiut University.
Trial summary
A study to compare the effect of tamsulosin versus the effect of paroxetine hydrochloride and the effect of combination of them on PE. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Tamsulosin and Paroxetine Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to May 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Married, sexually active patients with PE will be included with ages ranging from 20 to 60 years.
Who cannot join
- Patients suffering from erectile dysfunction, DM, HTN, neurological disorders and psychological disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Tamsulosin on Premature Ejaculation Compared With Paroxetine Hydrochloride
A study to compare the effect of tamsulosin versus the effect of paroxetine hydrochloride and the effect of combination of them on PE.
Read the detailed description
Premature ejaculation is considered the most common male sexual disorder. affecting approximately 4-39 % of men in general community. In 2008, the International Society for Sexual Medicine defined premature ejaculation as a male sexual dysfunction that is characterized by ejaculation that always or nearly always occurs within or before 1 minute of vaginal penetration. Moreover it is associated with presence of distress, frustration, bother, negative personal consequences, depression and the avoidance of sexual intimacy.
Many etiological theories have been included in the pathogenesis of premature ejaculation: neurobiological, psychological, environmental and endocrine factors. So a lot of therapeutic modalities, such as behavioral therapy, selective serotonin reuptake inhibitors (SSRIs), adrenergic alpha 1 antagonists, local anesthetic creams, clomipramine, phosphodiesterase type 5 inhibitors and centrally acting analgesics have been used for the treatment of premature ejaculation.
Previous studies reported that tamsulosin which is alpha blocker agent used as primary therapeutic agent for BPH is effective in the improvement of sexual function. However studies on the effect of tamsulosin on ejaculation reported that tamsulosin had inhibitory effect in the emission phase of ejaculation including decreased ejaculatory volume. So inhibitory effect of tamsulosin on ejaculation may be beneficial to patients suffering from premature ejaculation.
Historically, PE was considered psychological problem and was treated by behavioral treatment and psychotherapy but there is pharmacological studies increase the evidence that PE may be related to decreased serotonergic neurotransmission. So selective serotonin reuptake inhibitors (SSRIs ) such as : paroxetine, fluoxetine, dapoxetine, and sertraline are among the recommended pharmacological treatments for treating PE. But there is no universal agreement on the type, the dose and administration protocol.
So a study is needed to compare the value of combination therapy of both tamsulosin and paroxetine with the value of single therapy of either of them and consider Intravaginal Ejaculatory Latency Time (IELT) and ejaculatory control ability of patients after using tamsulosin and paroxetine.
- Conditions
- Premature Ejaculation
- Being tested
- Tamsulosin, Paroxetine Hydrochloride, placebo
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
drug will be used in treatment of premature ejaculation
Paroxetine HydrochlorideDrug
drug will be used in treatment of premature ejaculation
placeboOther
tablets without active substance will be given to patients suffering from premature ejaculation
| Study group | Role | What they receive |
|---|---|---|
| tamsulosin group | Active comparator | the first group will include 40 patients treated with daily administration of tamsulosin 0.4 mg Receives: Drug: Tamsulosin |
| paroxetine group | Active comparator | the second group will include 40 patients treated with daily administration of paroxetine 20 mg Receives: Drug: Paroxetine Hydrochloride |
| combined group | Active comparator | the third group will include 40 patients treated with daily administration of tamsulosin 0.4 mg and paroxetine 20 mg Receives: Drug: Tamsulosin; Drug: Paroxetine Hydrochloride |
| placrbo group | Placebo comparator | the fourth group will include 40 patients will be given placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Ejaculation Diagnostic Tool
Patients will be asked to complete the PEDT ( Premature Ejaculation Diagnostic Tool )
Cases will be scored as follow :
- Score of less than or equal 8 indicate no PE .
- Score of 9 and 10 indicate probable PE .
- Score of more than or equal 11 indicate PE After about 12 weeks the patients will be reevaluated also by ( PEDT ) and the results will be compared with the pretreatment ones
Measured: 3 months
Secondary outcomes (1)
Intravaginal Ejaculatory Latency Time
Patients will be asked to measure and record (IELT ) during 2 weeks before starting treatment . then they will be asked to measure and record ( IELT ) after each intercourse during and after period of treatment and will be compared with pretreatment measures
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Farrag, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879746
- Sponsor's protocol ID
- premature ejaculation
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tamsulosin on Premature Ejaculation Compared With Paroxetine Hydrochloride
- ClinicalTrials.gov ID
- NCT03879746
- Acronym / sponsor ID
- premature ejaculation
- Conditions
- Premature Ejaculation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to compare the effect of tamsulosin versus the effect of paroxetine hydrochloride and the effect of combination of them on PE.
Detailed description
Premature ejaculation is considered the most common male sexual disorder. affecting approximately 4-39 % of men in general community. In 2008, the International Society for Sexual Medicine defined premature ejaculation as a male sexual dysfunction that is characterized by ejaculation that always or nearly always occurs within or before 1 minute of vaginal penetration. Moreover it is associated with presence of distress, frustration, bother, negative personal consequences, depression and the avoidance of sexual intimacy.
Many etiological theories have been included in the pathogenesis of premature ejaculation: neurobiological, psychological, environmental and endocrine factors. So a lot of therapeutic modalities, such as behavioral therapy, selective serotonin reuptake inhibitors (SSRIs), adrenergic alpha 1 antagonists, local anesthetic creams, clomipramine, phosphodiesterase type 5 inhibitors and centrally acting analgesics have been used for the treatment of premature ejaculation.
Previous studies reported that tamsulosin which is alpha blocker agent used as primary therapeutic agent for BPH is effective in the improvement of sexual function. However studies on the effect of tamsulosin on ejaculation reported that tamsulosin had inhibitory effect in the emission phase of ejaculation including decreased ejaculatory volume. So inhibitory effect of tamsulosin on ejaculation may be beneficial to patients suffering from premature ejaculation.
Historically, PE was considered psychological problem and was treated by behavioral treatment and psychotherapy but there is pharmacological studies increase the evidence that PE may be related to decreased serotonergic neurotransmission. So selective serotonin reuptake inhibitors (SSRIs ) such as : paroxetine, fluoxetine, dapoxetine, and sertraline are among the recommended pharmacological treatments for treating PE. But there is no universal agreement on the type, the dose and administration protocol.
So a study is needed to compare the value of combination therapy of both tamsulosin and paroxetine with the value of single therapy of either of them and consider Intravaginal Ejaculatory Latency Time (IELT) and ejaculatory control ability of patients after using tamsulosin and paroxetine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tamsulosin group | Active comparator | Drug: Tamsulosinthe first group will include 40 patients treated with daily administration of tamsulosin 0.4 mg |
| paroxetine group | Active comparator | Drug: Paroxetine Hydrochloridethe second group will include 40 patients treated with daily administration of paroxetine 20 mg |
| combined group | Active comparator | Drug: Tamsulosin, Drug: Paroxetine Hydrochloridethe third group will include 40 patients treated with daily administration of tamsulosin 0.4 mg and paroxetine 20 mg |
| placrbo group | Placebo comparator | Other: placebothe fourth group will include 40 patients will be given placebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Married, sexually active patients with PE will be included with ages ranging from 20 to 60 years.
Key exclusion criteria (1 listed)
- Patients suffering from erectile dysfunction, DM, HTN, neurological disorders and psychological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tamsulosindrug will be used in treatment of premature ejaculation | Drug | combined group, tamsulosin group |
| Paroxetine Hydrochloridedrug will be used in treatment of premature ejaculation | Drug | combined group, paroxetine group |
| placebotablets without active substance will be given to patients suffering from premature ejaculation | Other | placrbo group |
Primary outcome
Premature Ejaculation Diagnostic Tool
Time frame: 3 months
Patients will be asked to complete the PEDT ( Premature Ejaculation Diagnostic Tool ) Cases will be scored as follow : * Score of less than or equal 8 indicate no PE . * Score of 9 and 10 indicate probable PE . * Score of more than or equal 11 indicate PE After about 12 weeks the patients will be reevaluated also by ( PEDT ) and the results will be compared with the pretreatment ones
1 secondary outcome
Intravaginal Ejaculatory Latency Time
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamsulosin and Paroxetine Hydrochloride in people with Premature Ejaculation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Farrag (201128359948 ext. 00+20, asmaafarrag14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature Ejaculation Diagnostic Tool (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.