Markers of Pubertal Suppression During Therapy for Precocious Puberty
| Status: | Terminated |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 3 - 9 |
| Updated: | 10/17/2018 |
| Start Date: | December 2013 |
| End Date: | December 2015 |
Markers of Adequate Pubertal Suppression During Supprelin LA Therapy for Central Precocious Puberty
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®.
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®.
During clinical trials of Supprelin LA®, leuprolide stimulation tests were performed to
determine adequacy of suppression. However, the use of this stimulation test to monitor
suppression requires an expensive medication and collection of multiple blood samples.
Alternative methods of monitoring pubertal suppression during gonadotropin releasing hormone
receptor agonist (GnRHa) therapy have included both random and trough levels of Luteinizing
Hormone (LH), estradiol or inhibin B. Recently, the free alpha subunit of pituitary
glycoprotein (FASPG) has also been shown to be a potentially useful marker of hormonal
suppression (Hirsch HJ, et al, JCEM 95:2841, 2010) as it undergoes a paradoxical rise
following initiation of therapy, and reverts to baseline upon completion.
In this investigator-initiated pilot study we will evaluate novel markers of pubertal
suppression in children receiving standard of care gonadotropin releasing hormone receptor
agonist therapy for the treatment of central precocious puberty. Children with central
precocious puberty who have selected treatment with Supprelin LA will undergo hormonal
testing of markers of pubertal activity before and after placement of the Supprelin LA
insert.
determine adequacy of suppression. However, the use of this stimulation test to monitor
suppression requires an expensive medication and collection of multiple blood samples.
Alternative methods of monitoring pubertal suppression during gonadotropin releasing hormone
receptor agonist (GnRHa) therapy have included both random and trough levels of Luteinizing
Hormone (LH), estradiol or inhibin B. Recently, the free alpha subunit of pituitary
glycoprotein (FASPG) has also been shown to be a potentially useful marker of hormonal
suppression (Hirsch HJ, et al, JCEM 95:2841, 2010) as it undergoes a paradoxical rise
following initiation of therapy, and reverts to baseline upon completion.
In this investigator-initiated pilot study we will evaluate novel markers of pubertal
suppression in children receiving standard of care gonadotropin releasing hormone receptor
agonist therapy for the treatment of central precocious puberty. Children with central
precocious puberty who have selected treatment with Supprelin LA will undergo hormonal
testing of markers of pubertal activity before and after placement of the Supprelin LA
insert.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Previous GnRHa therapy
- Presence of peripheral precocious puberty including CAH
We found this trial at
2
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