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Kisspeptin Administration in the Adult

Primary Purpose

Hypogonadotropic Hypogonadism, Kallmann Syndrome, GnRH Deficiency

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
kisspeptin 112-121
GnRH
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypogonadotropic Hypogonadism focused on measuring reproductive disorders, kisspeptin, hypogonadotropic hypogonadism, Kallmann Syndrome, PCOS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

kisspeptin, GnRH

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 4, 2009
Last Updated
July 17, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00914823
Brief Title
Kisspeptin Administration in the Adult
Official Title
Administration of Kisspeptin to Subjects With Reproductive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2009 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadotropic Hypogonadism, Kallmann Syndrome, GnRH Deficiency, PCOS, Polycystic Ovarian Syndrome, Hyperprolactinemia
Keywords
reproductive disorders, kisspeptin, hypogonadotropic hypogonadism, Kallmann Syndrome, PCOS

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
496 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
kisspeptin, GnRH
Arm Type
Experimental
Arm Description
Intravenous (IV) or subcutaneous (SC) administration of kisspeptin 112-121 and/or administration of GnRH
Intervention Type
Drug
Intervention Name(s)
kisspeptin 112-121
Other Intervention Name(s)
metastin 45-54
Intervention Description
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
Intervention Name(s)
GnRH
Other Intervention Name(s)
gonadotropin-releasing hormone
Intervention Description
One or more IV doses of GnRH, and/or SC administration of GnRH
Primary Outcome Measure Information:
Title
Average change in luteinizing hormone (LH) in response to kisspeptin
Time Frame
Within 30 minutes of administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Healthy Men: between 21 and 40 years old, normal erectile and ejaculatory function, no history of reproductive disorders, testicular volume >15 ml. 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. 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: 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. Women with Polycystic Ovarian Syndrome (PCOS) Confirmed diagnosis of PCOS, If needed, additional labs and imaging tests may be performed. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
617-726-5384
Email
MGHKisspeptinResearch@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie B Seminara, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-726-5384
Email
MGHKisspeptinResearch@partners.org
First Name & Middle Initial & Last Name & Degree
Stephanie B Seminara, MD
First Name & Middle Initial & Last Name & Degree
Yee-Ming Chan, MD, PhD
First Name & Middle Initial & Last Name & Degree
Margaret Lippincott, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31132118
Citation
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.
Results Reference
derived
PubMed Identifier
25226293
Citation
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.
Results Reference
derived

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Kisspeptin Administration in the Adult

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