Administration of Kisspeptin to Subjects With Reproductive Disorders

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Brief Title

Administration of Kisspeptin to Subjects With Reproductive Disorders

Official Title

Kisspeptin Administration in the Adult

Brief Summary

      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.
    

Detailed Description

      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 [email protected] or call
      617-726-8484. (We are not currently recruiting individuals with PCOS.)
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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


Condition

Hypogonadotropic Hypogonadism

Intervention

kisspeptin 112-121

Study Arms / Comparison Groups

 kisspeptin, GnRH
Description:  intravenous or subcutaneous administration of kisspeptin 112-121 and/or administration of GnRH

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

496

Start Date

March 2009

Completion Date

August 2025

Primary Completion Date

August 2025

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:

          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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Stephanie B. Seminara, MD, 617-726-8484, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00914823

Organization ID

2008-P-002486


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital


Study Sponsor

Stephanie B. Seminara, MD, Principal Investigator, Massachusetts General Hospital


Verification Date

June 2022