Inactive FSH in Galactosemia - Tabular View

Tracking Information

First Received Date ^ICMJE

February 6, 2008

Last Updated Date

February 6, 2008

Start Date ^ICMJE

March 2007

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Estradiol response [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Inactive FSH in Galactosemia

Official Title ^ICMJE

The Role of Inactive Follicle Stimulating Hormone in Ovarian Dysfunction in Galactosemia

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

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Open Label, Single Group Assignment

Condition ^ICMJE

Galactosemia
Premature Ovarian Failure

Intervention ^ICMJE

Drug: follitropin and lutropin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00619333

Responsible Party

Dr. M. E. Rubio-Gozalbo, Academic Hospital Maastricht

Study ID Numbers ^ICMJE

MEC 06-2-073

Study Sponsor ^ICMJE

Maastricht University Medical Center

Collaborators ^ICMJE

Galactosemie Vereniging Nederland (The Dutch Galactosemia Society)

Investigators ^ICMJE

Principal Investigator:

Estela Rubio-Gozalbo, MD, PhD

Maastricht University Hospital

Information Provided By

Maastricht University Medical Center

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP