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Trial · Interventional

CompletedPhase 1Registry data

Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

Overview

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

United States

Start
Sept 2011
Primary completion
Apr 2016
Completion
Apr 2016
First posted
21 Sept 2011 (estimated)
Last update posted
11 Jul 2022
Conditions
Hypogonadotropic Hypogonadism · Healthy Postmenopausal Women · Agonadism

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014201520162017
  1. Ph 1

    Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

    NCT01438073

    Sept 2011 to Apr 2016

Registry summary

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

The investigators are looking for subjects to complete a study on the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that tells the body to produce other reproductive hormones. However, giving someone a continued amount of kisspeptin over a period of time can have the opposite effect and tell the body to, for a short time, stop making hormones needed for reproduction. By giving 24-hour infusions of kisspeptin, the investigators hope to learn more about the role kisspeptin has in the way bodies function normally and the role it has in conditions that affect the reproductive system.

Interventions

  • kisspeptin 112-121Drug
  • GnRHDrug

Arms1

  • Experimental

    kisspeptin, GnRH

    24-hour continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg), and single bolus of GnRH (gonadotropin-releasing hormone) (2.5-250 ng/kg)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Average difference in Luteinizing Hormone (LH) concentration at the beginning and end of kisspeptin infusion

    Time frame · 24 hours

Secondary outcomes(2)
  1. Average difference in testosterone concentration at the beginning and end of kisspeptin infusion (males)

    Time frame · 24 hours

  2. Average difference in estradiol concentration at the beginning and end of kisspeptin infusion (females)

    Time frame · 24 hours

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2026

4 results

Dynamic modulation of LH secretion by continuous kisspeptin infusion in healthy men.

Naveed et al. 2026Hormones (Athens, Greece)

PMID 42230485PMC13386888DOI 10.1007/s42000-026-00795-yPUB-42230485

CC BY4 results

Other registry references

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

  • DerivedLippincott MF, Chan YM, Rivera Morales D, Seminara SB. Continuous Kisspeptin Administration in Postmenopausal Women: Impact of Estradiol on Luteinizing Hormone Secretion. J Clin Endocrinol Metab. 2017 Jun 1;102(6):2091-2099. doi: 10.1210/jc.2016-3952. PMID 28368443

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 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 difficulty with blood draws, * no prescription medications for at least 2 months with the exception of asthma medication (albuterol only), hypercholesterolemia medication and psychiatric medication, * 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 with no more than 5 days variability in cycle duration, * no evidence for androgen excess (hirsutism or acne), 3. Healthy postmenopausal women: * between 48 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: * all medical conditions stable and well controlled, medications allowed include asthma medication (albuterol only), hypercholesterolemia medication and psychiatric medication, * no 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, Additional criteria based on subject population: 1. Men and women with hypogonadotropic hypogonadism, * 18 years or older, * 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. Agonadal men, * Between 18 and 60 years old.

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