Back Pain and Male Sexual Disfunction | NCT01420731

Studies
Back Pain and Male Sexual Disfunction

NCT01420731

Sponsor

Bezmialem Vakif University

Status

Unknown status

Last Update Posted

Aug 22, 2011Estimated

Enrollment

54Estimated

Phase

Not provided

Conditions

Marriage, Life Event

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Aug 19, 2011

First Submission Date that Met QC Criteria

Aug 19, 2011

First Posted Date

Aug 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2011

Last Update Posted Date

Aug 22, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

gokcen basaranoglu, MD, Bezmialem Vakif UniversityPrincipal Investigator

Lead Sponsor

Bezmialem Vakif UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Back pain is a common hormonal disorder in men that may affect the phases of male sexual function. The investigators investigated sexual function in male patients with back pain.

A total of 54 men with back pain and 27 age matched voluntary healthy men who served as the as control group were evaluated with a detailed medical and sexual history, including a international erectile function index (IEFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male patient with back pain
20 - 45 years old
Active sexual life

Exclusion Criteria:

Younger than 20, older than 45 years old

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

20-45 years old,male patients with active sexual life

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gokcen Basaranoglu, MD	Contact	90 532 589 98 71		gbasaranoglu@hotmail.com

Overall Officials

Name	Affiliation	Role
Gökçen Başaranoğlu, MD	Beazialem Vakıf University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bezmialem Vakif University		Istanbul		34093	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D001416	Back Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided