Markers of Pubertal Suppression During Therapy for Precocious Puberty
Stopped early
Conditions studied: Central Precocious Puberty
In brief
The best way to measure whether treatment of children with central precocious puberty is working is to do a hormone stimulation test (leuprolide stimulation test) that requires injection of a medication and multiple blood draws to see if the hormonal response is suppressed (blocked). The hypothesis of this study is that random measurement of the free alpha subunit of pituitary glycoprotein, a protein related to the pituitary hormones that stimulate puberty, will provide an adequate alternative to the leuprolide stimulation testfor monitoring efficacy of pubertal suppression with Supprelin LA®.
Key facts
- Study ID
- NCT02006680
- Run by
- University of Minnesota
- People needed
- 4
- Starts
- 2013-12-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2018-10-15
Who can join
Age: 3 and older, up to 9. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female
- Age: 3 to 9 years old, inclusive
- Diagnosis of Central Precocious or Rapidly Progressive Puberty
- Bone Age more than 1 year advanced (obtained within 6 months of screening) AND
- Breasts Tanner II or greater AND
- One of the following:
- Random LH > 1 mIU/mL
- Leuprolide-stimulated LH > 4 mIU/mL
- Random estradiol > 20 pg/mL
- Leuprolide-stimulated 24 hour estradiol >20 pg/mL
- Naïve to GnRHa therapy
- Approved to receive Supprelin LA® therapy
- Have an acceptable surrogate capable of giving consent on the subject's behalf.
You may not qualify if…
- Previous GnRHa therapy
- Presence of peripheral precocious puberty including CAH
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States
- Atlantic Center for Research — Morristown, New Jersey, United States
Full record on ClinicalTrials.gov
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