TerminatedNot Applicable

Markers of Pubertal Suppression During Therapy for Precocious Puberty

Stopped: Inadequate Recruitment

United States4 participantsStarted 2013-12

Plain-language summary

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®.

Who can participate

Age range

3 Years – 9 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity and specificity of free alpha subunit of pituitary glycoprotein to identify subjects with appropriate pubertal suppression.

Timeframe: Up to 12 months

Trial details

NCT IDNCT02006680

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Central Precocious Puberty trials