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Administration of Kisspeptin to Subjects With Reproductive Disorders

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ClinicalTrials.gov Identifier: NCT00914823
Recruitment Status : Recruiting
First Posted : June 5, 2009
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Stephanie B. Seminara, MD, Massachusetts General Hospital

June 4, 2009
June 5, 2009
December 25, 2018
March 2009
December 2023   (Final data collection date for primary outcome measure)
Average change in luteinizing hormone (LH) in response to kisspeptin [ Time Frame: Within 30 minutes of administration ]
LH level [ Time Frame: 6 hours ]
Complete list of historical versions of study NCT00914823 on ClinicalTrials.gov Archive Site
Not Provided
  • FSH levels [ Time Frame: 6 hours ]
  • testosterone (males) [ Time Frame: 6 hours ]
  • estradiol (females) [ Time Frame: 6 hours ]
  • CBC [ Time Frame: 1 month ]
  • BUN [ Time Frame: 1 month ]
  • creatinine [ Time Frame: 1 month ]
  • liver function studies [ Time Frame: 1 month ]
Not Provided
Not Provided
 
Administration of Kisspeptin to Subjects With Reproductive Disorders
Kisspeptin Administration in the Adult
The investigators are seeking participants for a study of the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occuring hormone in humans that stimulates the production of reproductive hormones. The investigators hypothesize that kisspeptin administration will be a useful tool for characterizing certain reproductive disorders.

The master reproductive hormone GnRH (gonadotropin-releasing hormone) is essential for normal reproductive function. People with 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.

Individuals interested in learning more may email MGHKisspeptinResearch@partners.org or call 617-726-8484.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Hypogonadotropic Hypogonadism
  • Kallmann Syndrome
  • GnRH Deficiency
  • PCOS
  • Polycystic Ovarian Syndrome
  • Hyperprolactinemia
  • Drug: kisspeptin 112-121
    one or more intravenous doses of kisspeptin 112-121, and/or short infusion (up to 12 hours) of kisspeptin 112-121
    Other Name: metastin 45-54
  • Drug: GnRH
    One or more intravenous doses of GnRH
    Other Name: gonadotropin-releasing hormone
Experimental: kisspeptin, GnRH
intravenous administration of kisspeptin 112-121 and/or GnRH
Interventions:
  • Drug: kisspeptin 112-121
  • Drug: GnRH
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
496
100
December 2023
December 2023   (Final data collection date for primary outcome measure)

A. Healthy Subjects

All healthy subjects will meet the following criteria:

  • normal puberty with respect to onset and pace,
  • no chronic diseases,
  • 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 reference range.

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Isabella McDonald 617-726-8484 MGHKisspeptinResearch@partners.org
United States
 
 
NCT00914823
2008-P-002486
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Stephanie B. Seminara, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Stephanie B. Seminara, MD Massachusetts General Hospital
Massachusetts General Hospital
December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP