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Trial · Interventional

CompletedPhase 1Registry data

Kisspeptin Administration in the Adult

Overview

Status
Completed
Phase
Phase 1
Enrollment
256 participants (actual)
Sponsor
Massachusetts General Hospital · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
23 Jun 2009
Primary completion
22 Oct 2021
Completion
22 Oct 2021
First posted
5 Jun 2009 (estimated)
Last update posted
31 Jul 2024
Conditions
Hypogonadotropic Hypogonadism · Kallmann Syndrome · GnRH Deficiency · PCOS · Polycystic Ovarian Syndrome · Hyperprolactinemia

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201020152020
  1. Ph 1

    Kisspeptin Administration in the Adult

    NCT00914823

    23 Jun 2009 to 22 Oct 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • kisspeptin 112-121Drug
  • GnRHDrug

Arms1

  • Experimental

    kisspeptin, GnRH

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Average change in luteinizing hormone (LH) in response to kisspeptin

    Time frame · Within 30 minutes of administration

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Clinical trial · 2026

2 results

Intravenous kisspeptin 112-121 bolus does not acutely impact circulating vasopressin in humans.

Galbiati et al. 2026Journal of neuroendocrinologycited by 1

PMID 41273106PMC12797869DOI 10.1111/jne.70114PUB-41273106

Rights unknown2 results

Indexing hint: Clinical trial · 2025

3 results

Sex-dependent increases in oxytocin levels in response to intravenous kisspeptin in humans.

Galbiati et al. 2025European journal of endocrinologycited by 7

PMID 39965102PMC11886556DOI 10.1093/ejendo/lvaf001PUB-39965102

Rights unknown3 results

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedLippincott 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
  • DerivedChan 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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.

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