Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE)

NCT05556083 | Unknown Phase 2 DMC

• 1 other identifier: 61158m1
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Premature Ejaculation

Keywords

Premature ejaculation; Sildinafile; Dapoxitine

Outcome Measures

Primary Outcomes (2)

• intravaginal latency time changes IVLT

  Using PEDT premature ejaculation diagnostic tool (PEDT)

  Eight weaks for each participant of both groups

• overall partner satisfaction

  using Sexual Satisfaction Index (SSI).

  Eight weaks for each participants of both groups

Study Arms (2)

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.

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.

Drug: Placebo oral tablet and Dapoxitine 3mg Oral tablet

Interventions

Sildenafil 50 mg Oral Tablet and Dapoxitine 3mg Oral tablet DRUG

Single blind placebo randomized controlled trial

Also known as: viagra, prigily

sofenacine recievers group A

Placebo oral tablet and Dapoxitine 3mg Oral tablet DRUG

Single blind placebo randomized controlled trial

palcebo recievers group B

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients, age ≥20 years old, married and/or in a stable regular sexual relationship for at least 3 months before the study.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Sildenafil Citrate; Tablets

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Mohamed I Algammal, MD.

  urologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed I Algammal, MD

CONTACT

01000319556; gemykarter2020@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: participants of both groups will have no knowlage regarding the added medication they will recieve either sildinafile or placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Model Details: Single blind placebo randomized controlled trial

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: September 27, 2022
• Study Start: October 1, 2022
• Primary Completion: September 29, 2023
• Study Completion: November 1, 2023
• Last Updated: September 27, 2022

Record last verified: 2022-09