Kisspeptin Administration in the Adult

NCT00914823 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2008-P-002486
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypogonadotropic Hypogonadism; Kallmann Syndrome; GnRH Deficiency; PCOS; Polycystic Ovarian Syndrome; Hyperprolactinemia

Keywords

reproductive disorders; kisspeptin; hypogonadotropic hypogonadism; Kallmann Syndrome; PCOS

Outcome Measures

Primary Outcomes (1)

• Average change in luteinizing hormone (LH) in response to kisspeptin

  Within 30 minutes of administration

Study Arms (1)

kisspeptin, GnRH

EXPERIMENTAL

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

Drug: kisspeptin 112-121; Drug: GnRH

Interventions

kisspeptin 112-121 DRUG

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

Also known as: metastin 45-54

kisspeptin, GnRH

GnRH DRUG

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

Also known as: gonadotropin-releasing hormone

kisspeptin, GnRH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

A. Healthy Subjects All healthy subjects will meet the following criteria: * normal puberty with respect to onset and pace, * no chronic diseases, * no difficulty with blood draws, * no prescription medications for at least 2 months with the exception of seasonal allergy medications and hormone replacement therapy, * no illicit drug use or excessive alcohol consumption (\< 10 drinks/week), * no history of a medication reaction requiring emergency medical care, * normal physical exam and laboratory studies within protocol reference ranges. Additional criteria based on subject population: 1. Healthy Men: * between 21 and 40 years old, * normal erectile and ejaculatory function, no history of reproductive disorders, * testicular volume \>15 ml. 2. Healthy women: * between 21 and 40 years old, * not breastfeeding or pregnant, * menstrual cycles between 25 and 35 days in duration, at least 11 periods/year, with no more than 5 days variability in cycle duration, * no evidence for androgen excess (hirsutism or acne), * at screening, negative hCG pregnancy test, * negative screening for Factor V Leiden for those who might receive estradiol treatment as a part of this study. 3. Healthy postmenopausal women: * between 50 and 60 years old, * no menstrual periods within the last year, * previous history of menstrual cycles between 25 and 35 days in duration, with no more than 5 days variability in cycle duration, * if applicable, able to undergo washout from hormone therapy, * no evidence for androgen excess (hirsutism or acne), * negative screening for Factor V Leiden for those who might receive estradiol treatment as a part of this study. B. Subjects with Reproductive Disorders All subjects with reproductive disorders will meet the following criteria: * 18 years or older, * all medical conditions stable and well controlled, * no prescription medications known to affect reproductive endocrine function for at least 2 months except for medications used to treat the subject's reproductive condition, * no history of a medication reaction requiring emergency medical care, * no illicit drug use or excessive alcohol consumption (\<10 drinks/week), * for women, not breastfeeding or pregnant, * if applicable, able to undergo appropriate washout from hormone therapy, * normal physical exam and laboratory studies within protocol reference ranges, * for women, at time of screening negative hCG pregnancy test. Additional criteria based on subject population: 1. Men and women with hypogonadotropic hypogonadism, * Confirmed diagnosis by low sex steroids in the setting of low or inappropriately normal gonadotropins, * If needed, additional labs and imaging tests may be performed. 2. Women with Polycystic Ovarian Syndrome (PCOS) * Confirmed diagnosis of PCOS, * If needed, additional labs and imaging tests may be performed. 3. Men and women with hyperprolactinemia * confirmed diagnosis of elevated levels of prolactin measured via blood test, * no pituitary adenoma OR a microprolactinoma (\<10 mm). Patients with a macroprolactinoma confirmed on MRI imaging will be excluded, * willing to complete a dopamine agonist washout.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

• Galbiati F, Plessow F, Plummer L, Campbell MB, Nazarloo S, Carter CS, Davis JM, Miller KK, Carroll RS, Kaiser UB, Seminara SB, Aulinas A, Lawson EA. Intravenous kisspeptin 112-121 bolus does not acutely impact circulating vasopressin in humans. J Neuroendocrinol. 2026 Jan;38(1):e70114. doi: 10.1111/jne.70114. Epub 2025 Nov 22.

  PMID: 41273106 DERIVED

• 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.

  PMID: 39965102 DERIVED

• 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.

  PMID: 31132118 DERIVED

• 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.

  PMID: 25226293 DERIVED

MeSH Terms

Conditions

Hypogonadism; Kallmann Syndrome; Polycystic Ovary Syndrome; Hyperprolactinemia

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Disorder of Sex Development, 46,XY; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Stephanie B Seminara, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 5, 2009
• Study Start: June 23, 2009
• Primary Completion: October 22, 2021
• Study Completion: October 22, 2021
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)