Kisspeptin Administration in the Adult

NCT ID: NCT00914823

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-23

Study Completion Date

2021-10-22

Brief Summary

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The goal of this study is to learn about the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that causes the release of other hormones, including gonadotropin-releasing hormone (GnRH) in the body.

Detailed Description

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The reproductive hormone GnRH is essential for normal reproductive function. People with idiopathic hypogonadotropic hypogonadism (IHH), hyperprolactinemia, and polycystic ovarian syndrome (PCOS) do not secrete or respond to GnRH in a normal way. In this study, investigators will give participants kisspeptin-a hormone that is naturally found in the human body and is known to be a powerful stimulus of GnRH secretion. They may also give participants GnRH to determine if participants will be able to fully respond to kisspeptin. The goal of this study is to use kisspeptin administration to probe the condition of GnRH neurons in people with various reproductive disorders to better understand the underlying reasons for the disorders. Investigators hope to gain new insights into GnRH neuronal function (or dysfunction) that will lead to better diagnostics in the future.

Conditions

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Hypogonadotropic Hypogonadism Kallmann Syndrome GnRH Deficiency PCOS Polycystic Ovarian Syndrome Hyperprolactinemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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kisspeptin, GnRH

Intravenous (IV) or subcutaneous (SC) administration of kisspeptin 112-121 and/or administration of GnRH

Group Type EXPERIMENTAL

kisspeptin 112-121

Intervention Type DRUG

One or more IV or SC doses of kisspeptin 112-121, and/or short infusion (up to 12 hours) of kisspeptin 112-121

GnRH

Intervention Type DRUG

One or more IV doses of GnRH, and/or SC administration of GnRH

Interventions

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kisspeptin 112-121

One or more IV or SC doses of kisspeptin 112-121, and/or short infusion (up to 12 hours) of kisspeptin 112-121

Intervention Type DRUG

GnRH

One or more IV doses of GnRH, and/or SC administration of GnRH

Intervention Type DRUG

Other Intervention Names

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metastin 45-54 gonadotropin-releasing hormone

Eligibility Criteria

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Exclusion Criteria

* willing to complete a dopamine agonist washout.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stephanie B. Seminara, MD

Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephanie B Seminara, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Galbiati F, Plessow F, Plummer L, Campbell MB, Nazarloo S, Carter CS, Carroll RS, Kim HK, Pereira SA, Paulis D, Davis JM, Miller KK, Kaiser UB, Seminara SB, Aulinas A, Lawson EA. Sex-dependent increases in oxytocin levels in response to intravenous kisspeptin in humans. Eur J Endocrinol. 2025 Mar 3;192(3):K24-K29. doi: 10.1093/ejendo/lvaf001.

Reference Type DERIVED
PMID: 39965102 (View on PubMed)

Lippincott MF, Leon S, Chan YM, Fergani C, Talbi R, Farooqi IS, Jones CM, Arlt W, Stewart SE, Cole TR, Terasawa E, Hall JE, Shaw ND, Navarro VM, Seminara SB. Hypothalamic Reproductive Endocrine Pulse Generator Activity Independent of Neurokinin B and Dynorphin Signaling. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4304-4318. doi: 10.1210/jc.2019-00146.

Reference Type DERIVED
PMID: 31132118 (View on PubMed)

Chan YM, Lippincott MF, Butler JP, Sidhoum VF, Li CX, Plummer L, Seminara SB. Exogenous kisspeptin administration as a probe of GnRH neuronal function in patients with idiopathic hypogonadotropic hypogonadism. J Clin Endocrinol Metab. 2014 Dec;99(12):E2762-71. doi: 10.1210/jc.2014-2233.

Reference Type DERIVED
PMID: 25226293 (View on PubMed)

Other Identifiers

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2008-P-002486

Identifier Type: -

Identifier Source: org_study_id

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