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NCT00734279 · ClinicalTrials.gov registry record · Early Phase 1
Follicle-Stimulating Hormone (FSH) and the Onset of Puberty
A Early Phase 1 study, sponsored by University of Utah.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 11
- Enrollment target
NCT00734279 is a Early Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 11 participants.
The verdict
NCT00734279, a Early Phase 1 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if the timing of the onset of puberty may be affected by FSH-regulatory peptides. We will determine how these peptides relate to FSH production in prepubertal and pubertal children by comparing the regulation of FSH control in children with precocious (early) puberty and delayed puberty. In this pilot study, we will stimulate the pubertal axis using an agonist of GnRH to determine the pubertal response of activin-A, inhibin-A and -B and follistatin. To determine baseline FSH secretion and FSH-regulatory peptide tone, we will block GnRH with a specific antagonist. These studies should lead to a better understanding of the role of FSH in controlling the onset of puberty and the pathogenesis of pubertal disorders.
Interventions
- DRUG Leuprolide Acetate - Early Puberty Leuprolide Visit
- DRUG Ganirelix - Early Puberty Ganirelix Visit
- DRUG Ganirelix - Delayed Puberty Ganirelix Visit
- DRUG Leuprolide Acetate- Delayed Puberty Leuprolide Visit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-03 |
| Est. Completion | 2010-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00734279
The ClinicalTrials.gov registry entry for NCT00734279 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Leuprolide Acetate - Early Puberty Leuprolide Visit is the first listed.
NCT00734279 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00734279 about?
NCT00734279 is a clinical study titled "Follicle-Stimulating Hormone (FSH) and the Onset of Puberty". The purpose of this study is to determine if the timing of the onset of puberty may be affected by FSH-regulatory peptides. We will determine how these peptides relate to FSH production in prepubertal and pubertal children by comparing the regulation of FSH control in children with precocious (earl...
What is the current status of trial NCT00734279?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 11 participants. The study started on 2006-03. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00734279?
The interventions under investigation include: Leuprolide Acetate - Early Puberty Leuprolide Visit (DRUG), Ganirelix - Early Puberty Ganirelix Visit (DRUG), Ganirelix - Delayed Puberty Ganirelix Visit (DRUG), Leuprolide Acetate- Delayed Puberty Leuprolide Visit (DRUG).
Who is sponsoring clinical trial NCT00734279?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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