Inactive FSH in Galactosemia

This study is ongoing, but not recruiting participants.

First Received: February 6, 2008 No Changes Posted

Sponsor:	Maastricht University Medical Center
Collaborator:	Galactosemie Vereniging Nederland (The Dutch Galactosemia Society)
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00619333

Purpose

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

Condition	Intervention
Galactosemia Premature Ovarian Failure	Drug: follitropin and lutropin

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment
Official Title:	The Role of Inactive Follicle Stimulating Hormone in Ovarian Dysfunction in Galactosemia

Resource links provided by NLM:

Genetics Home Reference related topics: galactosemia succinic semialdehyde dehydrogenase deficiency

MedlinePlus related topics: Premature Ovarian Failure

Drug Information available for: Follicle Stimulating Hormone

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

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

Estimated Enrollment:	25
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: follitropin and lutropin follitropin and lutropin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619333

Locations

Netherlands
Maastricht University Hospital
Maastricht, Netherlands

Sponsors and Collaborators

Maastricht University Medical Center

Galactosemie Vereniging Nederland (The Dutch Galactosemia Society)

Investigators

Principal Investigator:

Estela Rubio-Gozalbo, MD, PhD

Maastricht University Hospital

More Information

No publications provided

Responsible Party:	Academic Hospital Maastricht ( Dr. M. E. Rubio-Gozalbo )
Study ID Numbers:	MEC 06-2-073
Study First Received:	February 6, 2008
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00619333 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Metabolic Diseases
Gonadal Disorders
Galactosemias
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Central Nervous System Diseases
Ovarian Failure, Premature
Ovarian Diseases
Brain Diseases

Hormones
Pharmacologic Actions
Follicle Stimulating Hormone
Adnexal Diseases
Genital Diseases, Female
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Brain Diseases, Metabolic, Inborn
Carbohydrate Metabolism, Inborn Errors
Brain Diseases, Metabolic

ClinicalTrials.gov processed this record on November 27, 2009