NCT07627477

Brief Summary

Assess the relationship and the prevalence…" "To determine the prevalence of erectile dysfunction and premature ejaculation among depressed male patients and evaluate their association with depression severity."

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
May 2026Jun 2027

Study Start

First participant enrolled

May 1, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 7, 2026

Last Update Submit

May 31, 2026

Conditions

Keywords

Depression severityDepressionPremature EjaculationErectile Dysfunction

Outcome Measures

Primary Outcomes (2)

  • Assessment of Depression severity in premature Ejaculation patients

    Depression severity will be assessed using the 17-item Hamilton Depression Rating Scale (HAM-D-17), a clinician-administered instrument widely used to evaluate depressive symptoms. The total score ranges from 0 to 52, with higher scores indicating greater severity of depression. Scores will be analyzed to determine the relationship between depression severity and the occurrence and severity of premature ejaculation among male psychiatric patients using premature Ejaculation severity scale PEDS Interpretation of HAM-D 0-7: Normal 8-16: Mild depression 17-22: Moderate depression * 23: Severe depression Scoring of PEDS ≤ 8: No PE 9-10: Probable PE * 11: PE likely present Higher scores indicate greater severity of premature ejaculation.

    6 months

  • Assessment of Depression severity in Erectile Dysfunction patients

    Depression severity will be assessed using the 17-item Hamilton Depression Rating Scale (HAM-D-17), a clinician-administered instrument widely used to evaluate depressive symptoms. The total score ranges from 0 to 52, with higher scores indicating greater severity of Depression.Scores will be analyzed to determine the relationship between depression severity and the occurrence and severity of Erectile Dysfunction among male psychiatric patients using the 5-item International Index of Erectile Function (IIEF-5), . Total scores range from 5 to 25, with lower scores indicating more severe erectile dysfunction. Interpretation of HAM-D 0-7: Normal 8-16: Mild depression 17-22: Moderate depression ≥23: Severe depression Interpretation of IIEF 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction.

    6 months

Eligibility Criteria

Age25 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male married patients diagnosed with depressive disorder according to DSM5

You may qualify if:

  • Married male pt aged 25\_60yrs
  • Clinically diagnosed with depressive disorder DSM5
  • sexually active in the past 6 months

You may not qualify if:

  • pts with major medical or neurological disorders known to be impaired sexual activity
  • History of substance use disorder
  • Pts receiving medications known to cause sexual Dysfunction except antidepressants
  • Pts with primary sexual Dysfunction prior to the onset of Depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag faculty of medicine

Sohag, Egypt

Location

MeSH Terms

Conditions

DepressionErectile DysfunctionPremature Ejaculation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersEjaculatory Dysfunction

Study Officials

  • Ahmed L Elsayed, MD

    Faculty of medicine sohag university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 7, 2026

First Posted

June 4, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

June 4, 2026

Record last verified: 2026-05

Locations