Kisspeptin in the Evaluation of Delayed Puberty
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ClinicalTrials.gov Identifier: NCT01438034 |
Recruitment Status :
Recruiting
First Posted : September 21, 2011
Last Update Posted : July 5, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Delayed Puberty Kallmann Syndrome Hypogonadotropic Hypogonadism GnRH Deficiency | Drug: kisspeptin 112-121 Drug: GnRH | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Kisspeptin in the Evaluation of Delayed Puberty |
Study Start Date : | November 2011 |
Estimated Primary Completion Date : | November 2023 |
Estimated Study Completion Date : | November 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: kisspeptin
intravenous administration of kisspeptin 112-121 0.24 nmol/kg and GnRH 75 ng/kg
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Drug: kisspeptin 112-121
0.24 nmol/kg
Other Name: metastin 45-54 Drug: GnRH 75 ng/kg |
- Average change in luteinizing hormone (LH) in response to kisspeptin [ Time Frame: Within 30 minutes of administration ]

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Ages Eligible for Study: | 12 Years to 17 Years (Child) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438034
Contact: Study Coordinator | 617-726-8484 | MGHKisspeptinResearch@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Yee-Ming Chan, MD, PhD 617-726-9260 YMCHAN@mgh.harvard.edu | |
Principal Investigator: Stephanie B Seminara, MD | |
Sub-Investigator: Yee-Ming Chan, MD, PhD |
Principal Investigator: | Stephanie B Seminara, MD | Massachusetts General Hospital |
Responsible Party: | Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01438034 |
Other Study ID Numbers: |
2011P002885 |
First Posted: | September 21, 2011 Key Record Dates |
Last Update Posted: | July 5, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Kallmann Syndrome Hypogonadism Puberty, Delayed Gonadal Disorders Endocrine System Diseases |
Disorder of Sex Development, 46,XY Disorders of Sex Development Urogenital Abnormalities Congenital Abnormalities Genetic Diseases, Inborn |