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Inactive FSH in Galactosemia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Maastricht University Medical Center.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: February 20, 2008
Last Update Posted: January 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Galactosemie Vereniging Nederland (The Dutch Galactosemia Society)
Information provided by:
Maastricht University Medical Center
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: None (Open Label)
Official Title: The Role of Inactive Follicle Stimulating Hormone in Ovarian Dysfunction in Galactosemia

Resource links provided by NLM:

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Estradiol response [ Time Frame: 3 days ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619333

Maastricht University Hospital
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Galactosemie Vereniging Nederland (The Dutch Galactosemia Society)
Principal Investigator: Estela Rubio-Gozalbo, MD, PhD Maastricht University Hospital
  More Information

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
First Submitted: February 6, 2008
First Posted: February 20, 2008
Last Update Posted: January 12, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Primary Ovarian Insufficiency
Menopause, Premature
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
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
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs