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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
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation focused on measuring Premature ejaculation, Sildinafile, Dapoxitine

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    September 10, 2022
    Last Updated
    September 25, 2022
    Sponsor
    Al-Azhar University
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    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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