Precocious PubertyNCT00004344
Purification of Testis-Stimulating Factor in Precocious Puberty
An observational study of Precocious Puberty, run by National Center for Research Resources (NCRR).
Trial summary
OBJECTIVES: Purify and characterize a testis-stimulating factor in the blood of adult volunteers who had precocious puberty as boys. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Precocious Puberty
- What is being tested?
- leuprolide and testosterone
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Jan 1997to not given
- Phase
- Observational
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
Adult men diagnosed with precocious puberty (familial testotoxicosis) as boys
About this study
OBJECTIVES:
Purify and characterize a testis-stimulating factor in the blood of adult volunteers who had precocious puberty as boys.
Read the detailed description
PROTOCOL OUTLINE: Subjects are treated for 2 months with depot injections of leuprolide acetate every 4 weeks and testosterone replacement every 2 weeks. Hormone levels are tested every other week.
If luteinizing hormone and follicular-stimulating hormone levels are at or below detection on day 56, blood is drawn for a testis-stimulating factor bioassay and subsequent factor purification and characterization.
Volunteers are asked to repeat this 2-month procedure no more than 2 times every 12 months.
- Conditions
- Precocious Puberty
- Being tested
- leuprolide, testosterone
- Keywords
- endocrine disorders, precocious puberty, rare disease
- Medical subject headings
- Puberty, Precocious, Endocrine System Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leuprolideDrug
testosteroneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startJan 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precocious PubertyStudies 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
- Observational
- Enrolment
- 4 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Oregon Health and Science University
- Investigators
- Barry Albertson, Study chair, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004344
- Sponsor's protocol ID
- 199/11903
- Other IDs
- OHSU-3328
- Status last verified
- Feb 2000
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Purification of Testis-Stimulating Factor in Precocious Puberty
- ClinicalTrials.gov ID
- NCT00004344
- Acronym / sponsor ID
- 199/11903
- Conditions
- Precocious Puberty
- Keywords
- endocrine disorders, precocious puberty, rare disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Oregon Health and Science University
- Study start
- Jan 1997
- First posted
- 19 Oct 1999 (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.
OBJECTIVES:
Purify and characterize a testis-stimulating factor in the blood of adult volunteers who had precocious puberty as boys.
Detailed description
PROTOCOL OUTLINE: Subjects are treated for 2 months with depot injections of leuprolide acetate every 4 weeks and testosterone replacement every 2 weeks. Hormone levels are tested every other week.
If luteinizing hormone and follicular-stimulating hormone levels are at or below detection on day 56, blood is drawn for a testis-stimulating factor bioassay and subsequent factor purification and characterization.
Volunteers are asked to repeat this 2-month procedure no more than 2 times every 12 months.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| leuprolide | Drug | – |
| testosterone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
Barry Albertson study chair
Oregon Health and Science University
Questions about this trial
What is this clinical trial studying?
An observational study of Precocious Puberty, run by National Center for Research Resources (NCRR).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 24 Jun 2005.