Status:
COMPLETED
Kisspeptin in the Evaluation of Delayed Puberty
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Delayed Puberty
Kallmann Syndrome
Eligibility:
All Genders
12-17 years
Phase:
PHASE1
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 pu...
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 8 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01438034
Start Date
June 8 2013
End Date
September 10 2021
Last Update
October 19 2023
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114