Inactive FSH in Galactosemia

Premature Ovarian Failure Clinical Trial

Official title:

The Role of Inactive Follicle Stimulating Hormone in Ovarian Dysfunction in Galactosemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00619333
• Other study ID #: MEC 06-2-073
• Status: Active, not recruiting
• Phase: N/A
• First received: February 6, 2008
• Last updated: January 11, 2010
• Start date: March 2007

Study information

• Verified date: January 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Galactosemia
• Galactosemias
• Menopause, Premature
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Drug:
• follitropin and lutropin
follitropin and lutropin

Locations

Country	Name	City	State
Netherlands	Maastricht University Hospital	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Galactosemie Vereniging Nederland (The Dutch Galactosemia Society)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estradiol response		3 days	No