Children with delayed puberty Nutritional, Metabolic, Endocrine
Conditions
Interventions
Assessment of hormonal response to kisspeptin and GnRH in delayed puberty.
Visit 1: Following intravenous administration of GnRH (2.5mcg/kg, maximum dose 100mcg) serum reproductive hormones are measur
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children with delayed puberty. Girls aged = 13 years old, boys aged = 14 years old.
Exclusion criteria
Exclusion criteria: 1. The child is unable or unwilling to give assent 2. Children with untreated anaemia 3. Children with a medical condition that could affect the reproductive axis and prevent evaluation of hormonal response to kisspeptin 4. Children who are currently in a research study or have participated in research in the last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum luteinising hormone (LH) measured using blood test at each visit not more than every 15 minutes for up to 4 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum reproductive hormones (e.g. follicle stimulating hormone [FSH]; testosterone in boys and oestradiol and progesterone in girls) measured using blood test not more than every 10 minutes for up to 8 hours. 2. Safety monitoring: heart rate, blood pressure (measured using automated blood pressure monitor every 15-30 minutes) and the presence of adverse symptoms. | — |
Countries
England, United Kingdom
Contacts
Public ContactAli Abbara
Outcome results
None listed