Kisspeptin in the Evaluation of Delayed Puberty

Mass General Brigham

Status and phase

Completed

Phase 1

Conditions

Delayed Puberty

Kallmann Syndrome

Hypogonadotropic Hypogonadism

GnRH Deficiency

Treatments

Drug: GnRH

Drug: kisspeptin 112-121

Study type

Interventional

Funder types

Other

Identifiers

NCT01438034

2011P002885

Details and patient eligibility

About

The goal of this study is to test whether the hormone kisspeptin has the potential to prospectively diagnose adolescents with self-resolving or permanent delayed puberty. 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.

Full description

The investigators are seeking boys (ages 13.5-17 years) and girls (ages 12-17) years with a diagnosis of delayed puberty. Study participation involves 2 outpatient visits and two hospital admissions (one 11-hour, overnight admission and one 6-hour day admission) when subjects will receive two investigational drugs, the naturally occurring hormones kisspeptin and gonadotropin-releasing hormone (GnRH). Subjects will then be followed every 6 months until they reach 18 years of age to determine if their pubertal delay was self-resolved or permanent.

Enrollment

24 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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