Premature EjaculationPhase 2PENCT05556083
Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE)
A Phase 2 study testing Sildenafil 50 mg Oral Tablet and Dapoxitine 3mg Oral tablet in people with Premature Ejaculation, run by Al-Azhar University.
Trial summary
Study Design: Single Blind Placebo Controlled Randomized Trial, aiming to assess the efficacy and safety of adding sildinafile 50 mg to dapoxitine 30 mg in dapoxitine non responding premature ejaculation. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Sildenafil 50 mg Oral Tablet and Dapoxitine 3mg Oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Nov 2023
- Phase
- Phase 2
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients, age ≥20 years old, married and/or in a stable regular sexual relationship for at least 3 months before the study.
Who cannot join
- - Men with associated erectile dysfunction (ED).
- Men with associated chronic prostatitis.
- Diabetes Mellitus (DM).
- Advanced renal or hepatic diseases.
- Neurological diseases and C.N.S. medications.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Adding Sildenafil to Dapoxetine in Treatment of Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE)
Study Design: Single Blind Placebo Controlled Randomized Trial, aiming to assess the efficacy and safety of adding sildinafile 50 mg to dapoxitine 30 mg in dapoxitine non responding premature ejaculation.
Read the detailed description
Study Design: Single Blind, Placebo Controlled Randomized Trial.
Study Setting: Urology outpatient clinics at Al-Hussein and Sayed Galal Hospitals; Al-Azhar University; Cairo; Egypt.
Timeline: 12 months [8 months for data collection; 2 months for thesis writing and 2 months for publication].
Study Population:
- The study participants will be males suffering from primary or acquired mono-symptomatic premature ejaculation (PE) that did not respond to 2 months of dapoxetine monotherapy.
- participants will considered to have PE if they fulfilled the criteria of the International Society for Sexual Medicine that defines PE as a male sexual dysfunction characterized by (i) ejaculation which always or nearly always occurs prior to or within 1 min of vaginal penetration, either present from the first sexual experience or following a new bothersome change in ejaculatory latency. (ii) Negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy(Gillman \& Gillman, 2019).
- Other patient inclusion criteria will be: age ≥20 years old, married and in a stable regular sexual relationship for at least 3 months before the study.
Exclusion criteria:
- Men with associated erectile dysfunction (ED).
- Men with associated chronic prostatitis.
- Diabetes Mellitus (DM).
- Advanced renal or hepatic diseases.
- Neurological diseases and C.N.S. medications.
- Contraindication to sildenafil as Nitric Oxide dependent ischemic heart disease patients or drug allergy.
Study Sample:
- All available cases with complete medical record and accepted follow-up with us will be included.
Study Procedures and Data Collection:
- Single blind placebo randomized controlled trial will be conducted on 200 male participants with PE divided into two groups 100 participant in each.
- The participants will be selected from those seeking medical advice at the outpatient clinics of Al-Hussein and Sayed Galal Hospitals; Al-Azhar University; Cairo; Egypt starting from October 2022.
- An informed consent will be obtained by each participant after full explanation for the nature of the research.
- The medical records of all adult males suffering from mono-symptomatic premature ejaculation who were treated with on demand dapoxetine for 2 months with no improvement and agree to participate in the study will be reviewed for,
- Demographic and clinical data as, age, comorbidities, occupation, parity, body mass index.
- Detailed medical and sexual history.
- All patients will be evaluated by the International Index of Erectile Function 5 (IIEF5) item questionnaires to exclude those with erectile dysfunction (score ≥22) and premature ejaculation diagnostic tool (PEDT).
- Physical examination including local abdominal and genital examination.
- Urine analysis with culture and sensitivity.
- Abdominopelvic ultrasonography.
- If needed Penile duplex US and Or Nocturnal Penile Tumescence and Rigidity (NPTR)will be performed to exclude organic ED. Participants of our study will be enrolled into two groups (A and B). participants enrollment will be done by simple randomization method through which none of participants know in which group he will be. Group (A) will receive sildenafil 50mg as additive therapy to dapoxetine 30 mg for 8 weeks. Group (B) will continue on dapoxetine 30mg with placebo for the same period as group (A). All patients will be instructed to do sexual intercourse 2-3 times a week.
- All patients were evaluated before and after the treatment by Premature Ejaculation Diagnostic Tool (PEDT) and IIEF-5, using the validated Arabic version of both questionnaires, Questionnaire will be fulfilled by face to face interview method.
Protection of Participants:
- The research will be explained in detail to the participants before inclusion in the study.
- Participants will sign an informed written consent before enrollment.
- Extreme care will be taken during the research related procedures.
- It will be made clear that the subject has the full right to withdraw from the study at any time.
- Informed consent and all study material will be kept in separate lockers; not accessed except by study investigators.
- Conditions
- Premature Ejaculation
- Being tested
- Sildenafil 50 mg Oral Tablet and Dapoxitine 3mg Oral tablet, Placebo oral tablet and Dapoxitine 3mg Oral tablet
- Keywords
- Premature ejaculation, Sildinafile, Dapoxitine
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 50 mg Oral Tablet and Dapoxitine 3mg Oral tabletDrug
Also called viagra, prigily
Single blind placebo randomized controlled trial
Placebo oral tablet and Dapoxitine 3mg Oral tabletDrug
Single blind placebo randomized controlled trial
| Study group | Role | What they receive |
|---|---|---|
| sofenacine recievers group A | Active comparator | Group (A) will receive sildenafil 50mg tablet form as additive therapy to dapoxetine 30 mg tablet form on demand for 8 weeks. Receives: Drug: Sildenafil 50 mg Oral Tablet and Dapoxitine 3mg Oral tablet |
| palcebo recievers group B | Placebo comparator | Group (B) will continue on dapoxetine 30mg tablet form with placebo tablet form of the same shap and colour of sildinafile on demand for 8 weeks. Receives: Drug: Placebo oral tablet and Dapoxitine 3mg Oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
intravaginal latency time changes IVLT
Using PEDT premature ejaculation diagnostic tool (PEDT)
Measured: Eight weaks for each participant of both groups
overall partner satisfaction
using Sexual Satisfaction Index (SSI).
Measured: Eight weaks for each participants of both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion29 Sep 2023 (estimated)
- Study completion1 Nov 2023 (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 Al-Azhar 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blind placebo randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Almetwally Algammal,MD, Al-Azhar University
- Investigators
- Mohamed I Algammal, MD., Principal investigator, urologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556083
- Sponsor's protocol ID
- 61158m1
- Acronym
- PE
- Status last verified
- Sep 2022
- First submitted
- 10 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Sildenafil to Dapoxetine in Treatment of Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE)
- ClinicalTrials.gov ID
- NCT05556083
- Acronym / sponsor ID
- PE / 61158m1
- Conditions
- Premature Ejaculation
- Keywords
- Premature ejaculation, Sildinafile, Dapoxitine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 29 Sep 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 27 Sep 2022 (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.
Study Design: Single Blind Placebo Controlled Randomized Trial, aiming to assess the efficacy and safety of adding sildinafile 50 mg to dapoxitine 30 mg in dapoxitine non responding premature ejaculation.
Detailed description
Study Design: Single Blind, Placebo Controlled Randomized Trial.
Study Setting: Urology outpatient clinics at Al-Hussein and Sayed Galal Hospitals; Al-Azhar University; Cairo; Egypt.
Timeline: 12 months [8 months for data collection; 2 months for thesis writing and 2 months for publication].
Study Population:
- The study participants will be males suffering from primary or acquired mono-symptomatic premature ejaculation (PE) that did not respond to 2 months of dapoxetine monotherapy.
- participants will considered to have PE if they fulfilled the criteria of the International Society for Sexual Medicine that defines PE as a male sexual dysfunction characterized by (i) ejaculation which always or nearly always occurs prior to or within 1 min of vaginal penetration, either present from the first sexual experience or following a new bothersome change in ejaculatory latency. (ii) Negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy(Gillman \& Gillman, 2019).
- Other patient inclusion criteria will be: age ≥20 years old, married and in a stable regular sexual relationship for at least 3 months before the study.
Exclusion criteria:
- Men with associated erectile dysfunction (ED).
- Men with associated chronic prostatitis.
- Diabetes Mellitus (DM).
- Advanced renal or hepatic diseases.
- Neurological diseases and C.N.S. medications.
- Contraindication to sildenafil as Nitric Oxide dependent ischemic heart disease patients or drug allergy.
Study Sample:
- All available cases with complete medical record and accepted follow-up with us will be included.
Study Procedures and Data Collection:
- Single blind placebo randomized controlled trial will be conducted on 200 male participants with PE divided into two groups 100 participant in each.
- The participants will be selected from those seeking medical advice at the outpatient clinics of Al-Hussein and Sayed Galal Hospitals; Al-Azhar University; Cairo; Egypt starting from October 2022.
- An informed consent will be obtained by each participant after full explanation for the nature of the research.
- The medical records of all adult males suffering from mono-symptomatic premature ejaculation who were treated with on demand dapoxetine for 2 months with no improvement and agree to participate in the study will be reviewed for,
- Demographic and clinical data as, age, comorbidities, occupation, parity, body mass index.
- Detailed medical and sexual history.
- All patients will be evaluated by the International Index of Erectile Function 5 (IIEF5) item questionnaires to exclude those with erectile dysfunction (score ≥22) and premature ejaculation diagnostic tool (PEDT).
- Physical examination including local abdominal and genital examination.
- Urine analysis with culture and sensitivity.
- Abdominopelvic ultrasonography.
- If needed Penile duplex US and Or Nocturnal Penile Tumescence and Rigidity (NPTR)will be performed to exclude organic ED. Participants of our study will be enrolled into two groups (A and B). participants enrollment will be done by simple randomization method through which none of participants know in which group he will be. Group (A) will receive sildenafil 50mg as additive therapy to dapoxetine 30 mg for 8 weeks. Group (B) will continue on dapoxetine 30mg with placebo for the same period as group (A). All patients will be instructed to do sexual intercourse 2-3 times a week.
- All patients were evaluated before and after the treatment by Premature Ejaculation Diagnostic Tool (PEDT) and IIEF-5, using the validated Arabic version of both questionnaires, Questionnaire will be fulfilled by face to face interview method.
Protection of Participants:
- The research will be explained in detail to the participants before inclusion in the study.
- Participants will sign an informed written consent before enrollment.
- Extreme care will be taken during the research related procedures.
- It will be made clear that the subject has the full right to withdraw from the study at any time.
- Informed consent and all study material will be kept in separate lockers; not accessed except by study investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind placebo randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| sofenacine recievers group A | Active comparator | Drug: Sildenafil 50 mg Oral Tablet and Dapoxitine 3mg Oral tabletGroup (A) will receive sildenafil 50mg tablet form as additive therapy to dapoxetine 30 mg tablet form on demand for 8 weeks. |
| palcebo recievers group B | Placebo comparator | Drug: Placebo oral tablet and Dapoxitine 3mg Oral tabletGroup (B) will continue on dapoxetine 30mg tablet form with placebo tablet form of the same shap and colour of sildinafile on demand for 8 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male patients, age ≥20 years old, married and/or in a stable regular sexual relationship for at least 3 months before the study.
Key exclusion criteria (5 listed)
- - Men with associated erectile dysfunction (ED).
- Men with associated chronic prostatitis.
- Diabetes Mellitus (DM).
- Advanced renal or hepatic diseases.
- Neurological diseases and C.N.S. medications.
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 |
|---|---|---|
| Sildenafil 50 mg Oral Tablet and Dapoxitine 3mg Oral tabletAlso: viagra, prigilySingle blind placebo randomized controlled trial | Drug | sofenacine recievers group A |
| Placebo oral tablet and Dapoxitine 3mg Oral tabletSingle blind placebo randomized controlled trial | Drug | palcebo recievers group B |
Primary outcome
intravaginal latency time changes IVLT
Time frame: Eight weaks for each participant of both groups
Using PEDT premature ejaculation diagnostic tool (PEDT)
overall partner satisfaction
Time frame: Eight weaks for each participants of both groups
using Sexual Satisfaction Index (SSI).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
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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.
Mohamed I Algammal, MD. principal investigator
urologist
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sildenafil 50 mg Oral Tablet and Dapoxitine 3mg Oral tablet in people with Premature Ejaculation, run by Al-Azhar 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 5 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 27 Sep 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mohamed I Algammal, MD (01000319556, gemykarter2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intravaginal latency time changes IVLT (time frame: Eight weaks for each participant of both groups). The study lists 2 primary outcomes in all. 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 27 Sep 2022.