NCT01732172

Brief Summary

Men following after proven and treated urethritis, looking for signs of chronic genital inflammatory syndrome with oxidative stress. This group of patients will be compared to a control group with no urethritis and no history of urogenital infection. Monocentric, prospective trial. Duration of study : one year

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
18 days until next milestone

Study Start

First participant enrolled

December 10, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2016

Completed
Last Updated

March 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

November 19, 2012

Last Update Submit

March 23, 2026

Conditions

Urethritis

Keywords

UrethritisPrevalence of a chronic inflammatory male genital tract

Outcome Measures

Primary Outcomes (1)

  • Seminal elastase value

    The dosage of elastase will be do 6 months after the end of treatment.

    6 months after the end of treatment.

Secondary Outcomes (4)

  • Seminal elastase value

    12 months after the end of treatment.

  • Presence of markers of oxidative stress

    6 to 12 months after the end of treatment

  • Functional impairment of the glands of the reproductive tract

    6 to 12 months after the end of treatment

  • Signs reflecting the sperm function

    6 to 12 months after the end of treatment

Study Arms (2)

Patient Group

EXPERIMENTAL

Patient with urethritis

Other: Sperm sample

Control group

OTHER

Subjects with no urethritis and no history urogenital infection

Other: Sperm sample

Interventions

Sperm sampleOTHER

Sperm sample

Control groupPatient Group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged 18 and over
  • Voluntary and signed informed consent
  • Patients with clinical signs of urethritis / or
  • Patients with positive chlamydial research, or Mycoplasma genitallium or Garderella vaginalis or gonorrhea in the sperm or first urinary stream;
  • \- Patients with no urethritis or no history of urogenital infection

You may not qualify if:

  • Subjects not wishing to participate in the study
  • Subjects that have not signed the informed consent
  • Those not affiliated to the social security system (or entitled beneficiary)
  • Immunodepressed or have an infection associated with HIV, HBV or HCV
  • Chronic systemic disease
  • \- Patients with no signs of urethritis
  • \- Subjects with signs of urethritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Cochin

Paris, 75014, France

Location

MeSH Terms

Conditions

Urethritis

Condition Hierarchy (Ancestors)

Urethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Jean-Philippe WOLF, MD, PhD

    Cochin Hospital

    PRINCIPAL INVESTIGATOR

  • Khaled POCATE, MD

    Cochin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 22, 2012

Study Start

December 10, 2012

Primary Completion

February 29, 2016

Study Completion

February 29, 2016

Last Updated

March 27, 2026

Record last verified: 2026-02

Locations

FR(1)