GalactosemiaNCT00619333
Inactive FSH in Galactosemia
A study testing follitropin and lutropin in people with Galactosemia and Premature Ovarian Failure, run by Maastricht University Medical Center at 1 site in Netherlands.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Galactosemia, Premature Ovarian Failure
- What is being tested?
- follitropin and lutropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of galactosemia through GALT-activity analysis and/or mutation analysis
- Premature Ovarian Failure with FSH > 30 U/l
Who cannot join
- Gynecological cancers and/or unexplained vaginal bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Inactive Follicle Stimulating Hormone in Ovarian Dysfunction in Galactosemia
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
- Conditions
- Galactosemia, Premature Ovarian Failure
- Being tested
- follitropin and lutropin
- Medical subject headings
- Galactosemias, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follitropin and lutropinDrug
follitropin and lutropin
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: follitropin and lutropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estradiol response
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startMar 2007
- Primary completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GalactosemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Dutch Galactosemia Society
- Investigators
- Estela Rubio-Gozalbo, MD, PhD, Principal investigator, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619333
- Sponsor's protocol ID
- MEC 06-2-073
- Status last verified
- Jan 2010
- First submitted
- 6 Feb 2008
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Inactive Follicle Stimulating Hormone in Ovarian Dysfunction in Galactosemia
- ClinicalTrials.gov ID
- NCT00619333
- Acronym / sponsor ID
- MEC 06-2-073
- Conditions
- Galactosemia, Premature Ovarian Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- The Dutch Galactosemia Society
- Study start
- Mar 2007
- Primary completion
- Mar 2010 (estimated)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: follitropin and lutropin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of galactosemia through GALT-activity analysis and/or mutation analysis
- Premature Ovarian Failure with FSH > 30 U/l
Key exclusion criteria (1 listed)
- Gynecological cancers and/or unexplained vaginal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follitropin and lutropinfollitropin and lutropin | Drug | 1 |
Primary outcome
Estradiol response
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Estela Rubio-Gozalbo, MD, PhD principal investigator
Maastricht University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing follitropin and lutropin in people with Galactosemia and Premature Ovarian Failure, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estradiol response (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010; AzTrials last refreshed its copy on 31 Oct 2026.