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Inactive FSH in Galactosemia

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. Identifier: NCT00619333
Recruitment Status : Unknown
Verified January 2010 by Maastricht University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : February 20, 2008
Last Update Posted : January 12, 2010
The Dutch Galactosemia Society
Information provided by:
Maastricht University Medical Center

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

Condition or disease Intervention/treatment Phase
Galactosemia Premature Ovarian Failure Drug: follitropin and lutropin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Role of Inactive Follicle Stimulating Hormone in Ovarian Dysfunction in Galactosemia
Study Start Date : March 2007
Estimated Primary Completion Date : March 2010

Arm Intervention/treatment
1 Drug: follitropin and lutropin
follitropin and lutropin

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00619333

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Maastricht University Hospital
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
The Dutch Galactosemia Society
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Principal Investigator: Estela Rubio-Gozalbo, MD, PhD Maastricht University Hospital

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Responsible Party: Dr. M. E. Rubio-Gozalbo, Academic Hospital Maastricht Identifier: NCT00619333     History of Changes
Other Study ID Numbers: MEC 06-2-073
First Posted: February 20, 2008    Key Record Dates
Last Update Posted: January 12, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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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