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
Galactosemie Vereniging Nederland (The Dutch Galactosemia Society)
Information provided by:
Maastricht University Medical Center Identifier:
First received: February 6, 2008
Last updated: January 11, 2010
Last verified: January 2010
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
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:

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


Ages Eligible for Study:   18 Years and older
Genders 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
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Please refer to this study by its identifier: 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 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:
Menopause, Premature
Primary Ovarian Insufficiency
Adnexal Diseases
Brain Diseases
Brain Diseases, Metabolic
Brain Diseases, Metabolic, Inborn
Carbohydrate Metabolism, Inborn Errors
Central Nervous System Diseases
Endocrine System Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Metabolic Diseases
Metabolism, Inborn Errors
Nervous System Diseases
Ovarian Diseases
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 26, 2016