Kisspeptin in the Evaluation of Delayed Puberty

2011P002885

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.

2013-06-08

2019-09-08

2021-09-10

Completed

Early phase I

24

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2023-10-19