Inactive FSH in Galactosemia | NCT00619333

Studies
Inactive FSH in Galactosemia

NCT00619333

Sponsor

Maastricht University Medical Center

Status

Unknown status

Last Update Posted

Jan 12, 2010Estimated

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Galactosemia
Premature Ovarian Failure

Interventions

follitropin and lutropin

Countries

Netherlands

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

Jan 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Mar 2010Estimated

Completion Date

Not provided

First Submitted Date

Feb 6, 2008

First Submission Date that Met QC Criteria

Feb 6, 2008

First Posted Date

Feb 20, 2008Estimated

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

Jan 11, 2010

Last Update Posted Date

Jan 12, 2010Estimated

Name	Class
The Dutch Galactosemia Society	OTHER

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

The aim of the study is to investigate whether inactive FSH plays a role in the development of Premature Ovarian Failure in women with Classic Galactosemia

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other		Drug: follitropin and lutropin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
follitropin and lutropin	Drug	follitropin and lutropin	1

Measure	Description	Time Frame
Estradiol response		3 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of galactosemia through GALT-activity analysis and/or mutation analysis
Premature Ovarian Failure with FSH > 30 U/l

Exclusion Criteria:

Gynecological cancers and/or unexplained vaginal bleeding

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
Estela Rubio-Gozalbo, MD, PhD	Maastricht University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Hospital		Maastricht			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D005693	Galactosemias
D016649	Primary Ovarian Insufficiency

Ancestor Terms

ID	Term
D020739	Brain Diseases, Metabolic, Inborn
D001928	Brain Diseases, Metabolic
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005640	Follicle Stimulating Hormone
D007986	Luteinizing Hormone

Ancestor Terms

ID	Term
D006065	Gonadotropins, Pituitary
D006062	Gonadotropins
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided