Kisspeptin Administration in the Adult

July 30, 2024 updated by: Stephanie B. Seminara, MD, Massachusetts General Hospital

Administration of Kisspeptin to Subjects With Reproductive Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: kisspeptin, GnRH
Intravenous (IV) or subcutaneous (SC) administration of kisspeptin 112-121 and/or administration of GnRH
Drug: 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
Other Names:
  • metastin 45-54
Drug: GnRH
One or more IV doses of GnRH, and/or SC administration of GnRH
Other Names:
  • gonadotropin-releasing hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average change in luteinizing hormone (LH) in response to kisspeptin
Time Frame: Within 30 minutes of administration
Within 30 minutes of administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Stephanie B Seminara, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2009

Primary Completion (Actual)

October 22, 2021

Study Completion (Actual)

October 22, 2021

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 4, 2009

First Posted (Estimated)

June 5, 2009

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-P-002486

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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