Effect of deslorelin-induced pubertal delay on the growth of adolescents with short stature and normally timed puberty: preliminary results.
G Municchi, S R Rose, O H Pescovitz...
https://pubmed.ncbi.nlm.nih.gov/8077329Completed
Phase 2
All Genders
ID00001190
A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients With Extreme Short Stature
Led by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Updated on 2008-03-04
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Children with extreme short stature (height) and their families often experience significant psychological stress related to concerns about adult height. In addition, short stature often results in life-long emotional, social, and physical obstacles to the affected person. Normal growth occurs in two phases. The first phase, known as childhood growth, occurs below the age of 10. The second phase of growth, teen-age or adolescent growth, begins between the ages of 10 and 15. In addition, puberty marks the time when the bone's growth plates (epiphysis) begin to close, initiating the completion of linear growth (height). Some children suffer from a condition called precocious puberty, meaning that puberty begins at a younger age than normal. The development of medications known as synthetic LHRH analogs have provided a method to delay puberty and treat these patients. LHRHa (deslorelin) is a hormone created to act like naturally occurring LHRH. It been used in patient's diagnosed with precocious (early onset) puberty. The drugs were able to regress patient's clinical signs of puberty, decrease the levels of adult sex hormones produced, and slow the rate of bone aging.
CONDITIONS
Official Title
Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients With Extreme Short Stature
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
Patients with extreme short stature will qualify for inclusion under this protocol if they meet the following criteria:
Age 9 through 15.99 years at the start of treatment.
Tanner II-V pubertal development.
Height at least 2.25 S.D. below the median for chronologic age at the time of pubertal onset, or a predicted adult height at least 2.25 S.D. below median adult height.
The height criterion must be met before study entry, but not necessarily on the actual date the patient starts to take the protocol injections because advancing puberty may cause an increase in height velocity that temporarily increases height standard deviation score.
Unfused carpal and phalangeal epiphyses by bone age x-ray.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States, 20892
Status Unknown
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Six-year results of luteinizing hormone releasing hormone (LHRH) agonist treatment in children with LHRH-dependent precocious puberty.
P K Manasco, O H Pescovitz, S C Hill...
https://pubmed.ncbi.nlm.nih.gov/2661787Linear growth as a function of age at onset of puberty and sex steroid dosage: therapeutic implications.
J P Bourguignon
https://pubmed.ncbi.nlm.nih.gov/3065075