NCT00619333

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Last Updated

January 12, 2010

Status Verified

January 1, 2010

Enrollment Period

3 years

First QC Date

February 6, 2008

Last Update Submit

January 11, 2010

Conditions

GalactosemiaPremature Ovarian Failure

Outcome Measures

Primary Outcomes (1)

  • Estradiol response

    3 days

Study Arms (1)

1

OTHER
Drug: follitropin and lutropin

Interventions

follitropin and lutropinDRUG

follitropin and lutropin

1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of galactosemia through GALT-activity analysis and/or mutation analysis
  • Premature Ovarian Failure with FSH \> 30 U/l

You may not qualify if:

  • Gynecological cancers and/or unexplained vaginal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Hospital

Maastricht, Netherlands

Location

MeSH Terms

Conditions

GalactosemiasPrimary Ovarian Insufficiency

Interventions

Follicle Stimulating HormoneLuteinizing Hormone

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCarbohydrate Metabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Estela Rubio-Gozalbo, MD, PhD

    Maastricht University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 20, 2008

Study Start

March 1, 2007

Primary Completion

March 1, 2010

Last Updated

January 12, 2010

Record last verified: 2010-01

Locations

NL(1)