Premature EjaculationNCT07057011
Therapeutic Outcomes of Selective Serotonin Reuptake Inhibitors and Phosphodiesterase-5 Inhibitors Combination Therapy Versus Monotherapy
A study testing Paroxetine 20 Mg Oral Tablet in people with Premature Ejaculation, run by South Valley University at 1 site in Egypt.
Trial summary
Premature ejaculation (PE) is a prevalent male sexual dysfunction that affects as many as 20-30% of men regardless of age and ethnicity.The International Society for Sexual Medicine defines premature ejaculation as a male sexual dysfunction characterised by ejaculation that always or nearly always occurs before or… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Paroxetine 20 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2025to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with PE: Men aged 18-60 years with a diagnosis of PE according to the International Society for Sexual Medicine (ISSM) criteria.
- Healthy controls: Men aged 18-60 years without a history of PE or other sexual dysfunctions.
Who cannot join
- Other sexual dysfunctions: Erectile dysfunction, delayed ejaculation, or other sexual disorders.
- Cardiovascular disease: history of cardiovascular disease, hypertension, or stroke.
- Neurological or psychiatric disorders: Conditions that may affect sexual function, such as depression, anxiety, or Parkinson's disease.
- Medications affecting sexual function: Current use of medications that may impact sexual function, such as antidepressants or antipsychotics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
South Valley University Hospital
Qina
Eisa Mohammed Hegazy, Professor, +201094337795, eisa_mohamed4152@med.svu.edu.eg
Soheir Abdel-Hamid Ali, Lecturer, +201066877343, Soher.abdel-hamed@med.svu.edu.eg
About this study
Official title: Therapeutic Outcomes of Selective Serotonin Reuptake Inhibitors and Phosphodiesterase-5 Inhibitors Combination Therapy Versus Monotherapy in Premature Ejaculation Patients With the Serotonin Transporter Gene Polymorphism (SLC6A4)
Premature ejaculation (PE) is a prevalent male sexual dysfunction that affects as many as 20-30% of men regardless of age and ethnicity.The International Society for Sexual Medicine defines premature ejaculation as a male sexual dysfunction characterised by ejaculation that always or nearly always occurs before or within about 1 minute of vaginal penetration from the first sexual experience (lifelong premature ejaculation) or a clinically significant and bothersome reduction in latency time, often to about 3 minutes or less (acquired premature ejaculation), the inability to delay ejaculation on all or nearly all vaginal penetrations and with negative personal consequences include distress, bother, frustration, and avoidance of sexual intimacy.
Read the detailed description
Oral intake of tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRI) has emerged as effective for patients with PE whether or not these patients suffered from depression. Sildenafil, a phosphodiesterase-5 inhibitor (PDE5i), was tried for premature ejaculation, and in one study associated with paroxetine (a SSRI), with IELT (intravaginal ejaculation latency time) going from 0.35 to 4.5 min.
Serotonin (5-hydroxytryptamine, 5-HT) plays an important role at the level of the central nervous system in the complex regulatory mechanisms involved in ejaculation. In clinical practice, selective serotonin reuptake inhibitor (SSRI) antidepressants (e.g., paroxetine, fluoxetine and sertraline) and the tricyclic antidepressant clomipramine are widely used to treat lifelong PE, suggesting that 5-HT and SSRIs play roles in the pathophysiology and treatment of PE. In this group, paroxetine and sertraline are often used effectively to treat PE, although none of these agents have been officially recognized as treatments for this condition.
SSRIs increase synaptic 5-HT concentrations in the ejaculation-related areas of the central nervous system by blocking 5-HT transporters. The serotonin transporter (5-HTT) plays an important role in the clearance of synaptic 5-HT, thereby regulating presynaptic and postsynaptic 5-HT receptor stimulation. Human 5-HTT is encoded by a single gene (SLC6A4) on chromosome 17q12. A polymorphism in the transcribed region can be caused by a 44-bp insertion ('long allele' [L]) or deletion ('short allele' [S]).
The transcriptional activity of the L allele has been reported to be twice as high as the S allele. Theoretically, men with one or more S alleles for the 5-HTT have fewer functioning transporters and could therefore lead to a higher serotonergic neurotransmission. Consequently, it is postulated that men with SS genotype have longer IELT durations than men with LL genotype.In the literature, a variety of findings have been reported concerning the relationship between 5-HTT polymorphism and the SSRI response.
- Conditions
- Premature Ejaculation
- Being tested
- Paroxetine 20 Mg Oral Tablet
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paroxetine 20 Mg Oral TabletDrug
Also called sildenafil 25mg Oral Tablet, Placebo
to compare the safety and efficacy of paroxetine alone versus the combination of paroxetine and sildenafil in Premature Ejaculation Patients with genetic polymorphism in the serotonin transporter gene-linked polymorphic region.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Drug Comination Therapy) | Active comparator | Twenty patients with premature ejaculation , matching inclusion \& exclusion criteria as mentioned before, will receive SSRI (paroxetine 20mg/day) + PDE5 inhibitor (sildenafil 25mg/day) for 3 months . Follow up clinically every 4 weeks for 12 weeks. Receives: Drug: Paroxetine 20 Mg Oral Tablet |
| Group B (Monotherapy) | Active comparator | Twenty patients with premature ejaculation will receive SSRI (paroxetine 20mg/day) + placebo for 3 months . Follow up clinically every 4 weeks for 12 weeks. Receives: Drug: Paroxetine 20 Mg Oral Tablet |
| Group C (Control) | Active comparator | Twenty healthy matched individuals will receive placebo + placebo for 3 months . Follow up clinically every 4 weeks for 12 weeks. Receives: Drug: Paroxetine 20 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of premature ejaculation
Treating the patients whom having Premature Ejaculation with selective serotonin reuptake inhibitors and Phosphodiesterase-5 Inhibitors Combination Therapy with genetic polymorphism in the serotonin transporter gene-linked polymorphic region.
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 posted9 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion10 Feb 2026 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed, South Valley University
- Investigators
- Mostafa Adam Ali El-Taib, Professor, Study chair, Dermatology, venereology and andrology ,Qena Faculty of medicine ,south valley university.Ebtehal Alaa El-Din Kotop Mohamed, Lecturer, Study director, Dermatology, venereology and andrology ,Qena Faculty of medicine ,south valley university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057011
- Sponsor's protocol ID
- ٍSerotonin Reuptake Inhibitors
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Outcomes of Selective Serotonin Reuptake Inhibitors and Phosphodiesterase-5 Inhibitors Combination Therapy Versus Monotherapy in Premature Ejaculation Patients With the Serotonin Transporter Gene Polymorphism (SLC6A4)
- ClinicalTrials.gov ID
- NCT07057011
- Acronym / sponsor ID
- ٍSerotonin Reuptake Inhibitors
- Conditions
- Premature Ejaculation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 10 Feb 2026 (estimated)
- First posted
- 9 Jul 2025 (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.
Premature ejaculation (PE) is a prevalent male sexual dysfunction that affects as many as 20-30% of men regardless of age and ethnicity.The International Society for Sexual Medicine defines premature ejaculation as a male sexual dysfunction characterised by ejaculation that always or nearly always occurs before or within about 1 minute of vaginal penetration from the first sexual experience (lifelong premature ejaculation) or a clinically significant and bothersome reduction in latency time, often to about 3 minutes or less (acquired premature ejaculation), the inability to delay ejaculation on all or nearly all vaginal penetrations and with negative personal consequences include distress, bother, frustration, and avoidance of sexual intimacy.
Detailed description
Oral intake of tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRI) has emerged as effective for patients with PE whether or not these patients suffered from depression. Sildenafil, a phosphodiesterase-5 inhibitor (PDE5i), was tried for premature ejaculation, and in one study associated with paroxetine (a SSRI), with IELT (intravaginal ejaculation latency time) going from 0.35 to 4.5 min.
Serotonin (5-hydroxytryptamine, 5-HT) plays an important role at the level of the central nervous system in the complex regulatory mechanisms involved in ejaculation. In clinical practice, selective serotonin reuptake inhibitor (SSRI) antidepressants (e.g., paroxetine, fluoxetine and sertraline) and the tricyclic antidepressant clomipramine are widely used to treat lifelong PE, suggesting that 5-HT and SSRIs play roles in the pathophysiology and treatment of PE. In this group, paroxetine and sertraline are often used effectively to treat PE, although none of these agents have been officially recognized as treatments for this condition.
SSRIs increase synaptic 5-HT concentrations in the ejaculation-related areas of the central nervous system by blocking 5-HT transporters. The serotonin transporter (5-HTT) plays an important role in the clearance of synaptic 5-HT, thereby regulating presynaptic and postsynaptic 5-HT receptor stimulation. Human 5-HTT is encoded by a single gene (SLC6A4) on chromosome 17q12. A polymorphism in the transcribed region can be caused by a 44-bp insertion ('long allele' [L]) or deletion ('short allele' [S]).
The transcriptional activity of the L allele has been reported to be twice as high as the S allele. Theoretically, men with one or more S alleles for the 5-HTT have fewer functioning transporters and could therefore lead to a higher serotonergic neurotransmission. Consequently, it is postulated that men with SS genotype have longer IELT durations than men with LL genotype.In the literature, a variety of findings have been reported concerning the relationship between 5-HTT polymorphism and the SSRI response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Drug Comination Therapy) | Active comparator | Drug: Paroxetine 20 Mg Oral TabletTwenty patients with premature ejaculation , matching inclusion \& exclusion criteria as mentioned before, will receive SSRI (paroxetine 20mg/day) + PDE5 inhibitor (sildenafil 25mg/day) for 3 months . Follow up clinically every 4 weeks for 12 weeks. |
| Group B (Monotherapy) | Active comparator | Drug: Paroxetine 20 Mg Oral TabletTwenty patients with premature ejaculation will receive SSRI (paroxetine 20mg/day) + placebo for 3 months . Follow up clinically every 4 weeks for 12 weeks. |
| Group C (Control) | Active comparator | Drug: Paroxetine 20 Mg Oral TabletTwenty healthy matched individuals will receive placebo + placebo for 3 months . Follow up clinically every 4 weeks for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with PE: Men aged 18-60 years with a diagnosis of PE according to the International Society for Sexual Medicine (ISSM) criteria.
- Healthy controls: Men aged 18-60 years without a history of PE or other sexual dysfunctions.
Key exclusion criteria (4 listed)
- Other sexual dysfunctions: Erectile dysfunction, delayed ejaculation, or other sexual disorders.
- Cardiovascular disease: history of cardiovascular disease, hypertension, or stroke.
- Neurological or psychiatric disorders: Conditions that may affect sexual function, such as depression, anxiety, or Parkinson's disease.
- Medications affecting sexual function: Current use of medications that may impact sexual function, such as antidepressants or antipsychotics.
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 |
|---|---|---|
| Paroxetine 20 Mg Oral TabletAlso: sildenafil 25mg Oral Tablet, Placeboto compare the safety and efficacy of paroxetine alone versus the combination of paroxetine and sildenafil in Premature Ejaculation Patients with genetic polymorphism in the serotonin transporter gene-linked polymorphic region. | Drug | Group A (Drug Comination Therapy), Group B (Monotherapy), Group C (Control) |
Primary outcome
Treatment of premature ejaculation
Time frame: 3 months
Treating the patients whom having Premature Ejaculation with selective serotonin reuptake inhibitors and Phosphodiesterase-5 Inhibitors Combination Therapy with genetic polymorphism in the serotonin transporter gene-linked polymorphic region.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Premature Ejaculation
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Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)
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Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE
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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.
Mostafa Adam Ali El-Taib, Professor study chair
Dermatology, venereology and andrology ,Qena Faculty of medicine ,south valley university.
Ebtehal Alaa El-Din Kotop Mohamed, Lecturer study director
Dermatology, venereology and andrology ,Qena Faculty of medicine ,south valley university.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paroxetine 20 Mg Oral Tablet in people with Premature Ejaculation, run by South Valley University at 1 site in Egypt.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Ahmed Mohamed Mousaa, MSC (+201061574354, drmohamedelmurshedy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of premature ejaculation (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 9 Jul 2025.