Kisspeptin in the Evaluation of Delayed Puberty
This study is currently recruiting participants.
(see Contacts and Locations)
Verified April 2016 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Stephanie B. Seminara, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01438034
First received: August 24, 2011
Last updated: April 15, 2016
Last verified: April 2016
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Purpose
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 617-724-8592.
| Condition | Intervention | Phase |
|---|---|---|
|
Delayed Puberty Kallmann Syndrome Hypogonadotropic Hypogonadism GnRH Deficiency |
Drug: kisspeptin 112-121 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Kisspeptin in the Evaluation of Delayed Puberty |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Luteinizing hormone (LH) level [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Follicle stimulating hormone (FSH) levels [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- testosterone (males) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- estradiol (females) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
- Complete blood count (CBC) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Blood urea nitrogen (BUN) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- creatinine [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- liver function studies [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2020 |
| Estimated Primary Completion Date: | November 2020 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: kisspeptin
intravenous administration of kisspeptin 112-121 0.24 nmol/kg.
|
Drug: kisspeptin 112-121
0.24 nmol/kg
Other Name: metastin 45-54
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438034
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438034
Contacts
| Contact: Tope Kusa, MBBS, MPH | 617-726-8622 | MGHKisspeptinResearch@partners.org | |
| Contact: Dianali Rivera Morales, MS | 617-724-8764 | MGHKisspeptinResearch@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Yee-Ming Chan, MD, PhD 617-726-9260 ymchan@partners.org | |
| Principal Investigator: Stephanie B Seminara, MD | |
| Sub-Investigator: Yee-Ming Chan, MD, PhD | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Stephanie B Seminara, MD | Massachusetts General Hospital |
More Information
| Responsible Party: | Stephanie B. Seminara, MD, Associate in Medicine, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01438034 History of Changes |
| Other Study ID Numbers: | 2010-P-001453 |
| Study First Received: | August 24, 2011 |
| Last Updated: | April 15, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypogonadism Kallmann Syndrome Puberty, Delayed Gonadal Disorders Endocrine System Diseases |
46, XY Disorders of Sex Development Disorders of Sex Development Urogenital Abnormalities Congenital Abnormalities Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on September 23, 2016