Kisspeptin in the Evaluation of Delayed Puberty

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Some children with delayed puberty will eventually enter puberty on their own. However, some children with delayed puberty have a permanent condition and require medical treatment to undergo puberty. Right now, there is no reliable diagnostic tool to tell whether a child's delayed puberty will be self-resolving or permanent. The hormone kisspeptin has the potential to prospectively diagnose adolescents with self-resolving or permanent delayed puberty.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

Inclusion Criteria:

Adolescent Boys

• ages 13.5-17 years

• testicular volume <4 mL OR 4-8 ml with no change in the past 6 months by Prader orchidometer

• first morning (before 9AM) LH <2 mIU/mL and testosterone <50 ng/dL

Adolescent Girls

• ages 12-17 years

• Tanner stage I OR II breast development with no change in the past 6 months

• first morning (before 9AM) LH <2 mIU/mL and estradiol <20 pg/ml

All Subjects:

• bone age less than chronological age

• weight ≥ 28 kg

• body mass index >10th percentile and <+3 SDS for bone age

• blood pressure >5th percentile and <95th percentile for bone age and height

• white blood cell counts, platelet counts, electrolytes, thyroid stimulating hormone (TSH), free thyroxine (T4) within reference range for age

• erythrocyte sedimentation rate <2X the upper limit of the reference range for age

• hemoglobin within reference range for girls of the same chronological age

• blood urea nitrogen (BUN), creatinine, prolactin not elevated

• aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no more than 2X the upper limit of the reference range

• Insulin-like growth factor 1 (IGF-1) within reference range for bone age

Exclusion Criteria:

All Subjects:

• history or presence of underlying condition that could cause delayed puberty (chronic illness, weight loss, abnormal cranial magnetic resonance imaging (MRI))

• history of an allergic drug reaction