Kisspeptin in the Evaluation of Delayed Puberty
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Average change in luteinizing hormone (LH) in response to kisspeptin
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Kisspeptin, GnRH
Intravenous (IV) administration of kisspeptin 112-121 0.24 nmol/kg and GnRH 75 ng/kg
Intervention: kisspeptin 112-121 (Drug)
Kisspeptin, GnRH
Intravenous (IV) administration of kisspeptin 112-121 0.24 nmol/kg and GnRH 75 ng/kg
Intervention: GnRH (Drug)
Outcomes
Primary Outcomes
Average change in luteinizing hormone (LH) in response to kisspeptin
Time Frame: Within 30 minutes of administration
Secondary Outcomes
No secondary outcomes reported
Investigators
Stephanie B. Seminara, MD
Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine
Massachusetts General Hospital