Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tolmar Inc.
Leuprolide acetate is a GnRH agonist that inhibits pituitary gonadotropin secretion by binding to the GnRH receptors and blocking downstream hormone synthesis. The steady decrease in hormone synthesis (LH and FSH) leads to a suppression of testicular and ovarian steroidogenesis. In children with CPP, this steady decrease in hormone synthesis disrupts the progression of puberty.
Age
2–9
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive)
Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
Pubertal-type LH response following an abbreviated GnRHa stimulation test before treatment initiation
Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males
Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year
Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1)
Diagnosis of short stature (ie, 2.25 standard deviations (SD) below the mean height for age)
Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study
Clareo Health | Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
