Inactive FSH in Galactosemia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by Maastricht University Medical Center. Recruitment status was Active, not recruiting

First Received on February 6, 2008. Last Updated on January 11, 2010 History of Changes

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:	Intervention Model: Single Group Assignment Masking: Open Label
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 Turner syndrome

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:	Dr. M. E. Rubio-Gozalbo, Academic Hospital Maastricht
ClinicalTrials.gov Identifier:	NCT00619333 History of Changes
Other Study ID Numbers:	MEC 06-2-073
Study First Received:	February 6, 2008
Last Updated:	January 11, 2010
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Galactosemias
Menopause, Premature
Primary Ovarian Insufficiency
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Carbohydrate Metabolism, Inborn Errors

Metabolic Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012