Kisspeptin in the Evaluation of Delayed Puberty
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 12 - 17 |
| Updated: | 12/22/2018 |
| Start Date: | November 2011 |
| End Date: | November 2020 |
| Contact: | Isabella McDonald |
| Email: | MGHKisspeptinResearch@partners.org |
| Phone: | 617-726-8484 |
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.
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.
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. Individuals interested in learning more may call 617-726-8484.
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. Individuals interested in learning more may call 617-726-8484.
Inclusion Criteria:
- adolescent boys (ages 13.5-17 years)
- adolescent girls (ages 12-17 years)
- testicular volume <4 mL OR 4-8 ml with no change in the past 6 months by Prader
orchidometer (boys), Tanner stage I OR II breast development with no change in the
past 6 months girls)
- first morning (before 9AM) LH <2 mIU/mL and testosterone <50 ng/dL (boys) estradiol
<20 pg/ml (girls)
- bone age less than chronological age
- weight ≥ 27 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, erythrocyte sedimentation rate,
electrolytes, thyroid stimulating hormone (TSH), free thyroxine (T4) within reference
range for age
- hemoglobin within reference range for girls of the same chronological age
- blood urea nitrogen (BUN), creatinine, prolactin no more than 1.25X the upper limit of
the reference range for age
- 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:
- history or presence of underlying condition that could cause delayed puberty (chronic
illness, weight loss, abnormal cranial magnetic resonance imaging (MRI))
- use of alcohol or illicit drugs
- history of an allergic drug reaction
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Stephanie B Seminara, MD
Phone: 617-726-9260
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