Decrease of Libido of Post-Operative Male-Female Transsex... | NCT00135148

Studies
Decrease of Libido of Post-Operative Male-Female Transsexuals and a Healthy Female Control Group

NCT00135148

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Dec 28, 2007Estimated

Enrollment

150

Phase

Not provided

Conditions

Transsexualism

Interventions

Filling out a questionnaire on libido and possible partner relationship
Sex steroid analysis

Countries

Belgium

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

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Not provided

Completion Date

Aug 2005Actual

First Submitted Date

Aug 24, 2005

First Submission Date that Met QC Criteria

Aug 24, 2005

First Posted Date

Aug 25, 2005Estimated

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

Dec 19, 2007

Last Update Posted Date

Dec 28, 2007Estimated

Name	Class
Organon	INDUSTRY

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

Participants fill out a questionnaire on libido and their possible partner relationship.

A blood sample is taken for sex steroid analysis.

Detailed Description

Participants fill out a questionnaire on libido and their possible partner relationship on the website http://www.onderzoek-libido.be.

A blood sample is taken for sex steroid analysis. The relation will be investigated between testosterone, free testosterone, sex hormone binding globulin, estradiol, DHEA and androstenedione and scores on relational and sexual satisfaction and sexual desire.

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Transsexual women with completed adaptation of the sex (all surgical procedures and hormonal treatments)
The female control group must be 18-45 years

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guy T'Sjoen, MD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

Label	URL
Website University Hospital Ghent	View source

Condition Browse Module

MeSH Terms

ID	Term
D014189	Transsexualism

Ancestor Terms

ID	Term
D019529	Sexuality
D012725	Sexual Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Filling out a questionnaire on libido and possible partner relationship	Procedure
Sex steroid analysis	Procedure