Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE) (PE)
Primary Purpose
Premature Ejaculation
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sildenafil 50 mg Oral Tablet and Dapoxitine 3mg Oral tablet
Placebo oral tablet and Dapoxitine 3mg Oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ejaculation focused on measuring Premature ejaculation, Sildinafile, Dapoxitine
Eligibility Criteria
Inclusion Criteria:
- Male patients, age ≥20 years old, married and/or 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
sofenacine recievers group A
palcebo recievers group B
Arm Description
Group (A) will receive sildenafil 50mg tablet form as additive therapy to dapoxetine 30 mg tablet form on demand for 8 weeks.
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.
Outcomes
Primary Outcome Measures
intravaginal latency time changes IVLT
Using PEDT premature ejaculation diagnostic tool (PEDT)
overall partner satisfaction
using Sexual Satisfaction Index (SSI).
Secondary Outcome Measures
Full Information
NCT ID
NCT05556083
First Posted
September 10, 2022
Last Updated
September 25, 2022
Sponsor
Al-Azhar University
1. Study Identification
Unique Protocol Identification Number
NCT05556083
Brief Title
Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE)
Acronym
PE
Official Title
Efficacy of Adding Sildenafil to Dapoxetine in Treatment of Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
September 29, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ejaculation
Keywords
Premature ejaculation, Sildinafile, Dapoxitine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Single blind placebo randomized controlled trial
Masking
Participant
Masking Description
participants of both groups will have no knowlage regarding the added medication they will recieve either sildinafile or placebo.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sofenacine recievers group A
Arm Type
Active Comparator
Arm Description
Group (A) will receive sildenafil 50mg tablet form as additive therapy to dapoxetine 30 mg tablet form on demand for 8 weeks.
Arm Title
palcebo recievers group B
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sildenafil 50 mg Oral Tablet and Dapoxitine 3mg Oral tablet
Other Intervention Name(s)
viagra, prigily
Intervention Description
Single blind placebo randomized controlled trial
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet and Dapoxitine 3mg Oral tablet
Intervention Description
Single blind placebo randomized controlled trial
Primary Outcome Measure Information:
Title
intravaginal latency time changes IVLT
Description
Using PEDT premature ejaculation diagnostic tool (PEDT)
Time Frame
Eight weaks for each participant of both groups
Title
overall partner satisfaction
Description
using Sexual Satisfaction Index (SSI).
Time Frame
Eight weaks for each participants of both groups
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male patients, age ≥20 years old, married and/or 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed I Algammal, MD
Phone
01000319556
Email
gemykarter2020@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed I Algammal, MD.
Organizational Affiliation
urologist
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE)
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