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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 : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Stephanie B. Seminara, MD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Hypogonadotropic Hypogonadism Kallmann Syndrome GnRH Deficiency PCOS Polycystic Ovarian Syndrome Hyperprolactinemia Drug: kisspeptin 112-121 Drug: GnRH Phase 1

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 MGHKisspeptinResearch@partners.org or call 617-726-8484.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 496 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Kisspeptin Administration in the Adult
Study Start Date : March 2009
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: kisspeptin, GnRH
intravenous administration of kisspeptin 112-121 and/or GnRH
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




Primary Outcome Measures :
  1. Average change in luteinizing hormone (LH) in response to kisspeptin [ Time Frame: Within 30 minutes of administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914823


Contacts
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Contact: Isabella McDonald 617-726-8484 MGHKisspeptinResearch@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Stephanie B. Seminara, MD         
Sub-Investigator: Yee-Ming Chan, MD, PhD         
Sub-Investigator: Margaret Lippincott, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Stephanie B. Seminara, MD Massachusetts General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stephanie B. Seminara, MD, Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00914823     History of Changes
Other Study ID Numbers: 2008-P-002486
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Hyperprolactinemia
Kallmann Syndrome
Hypogonadism
Syndrome
Disease
Pathologic Processes
Gonadal Disorders
Endocrine System Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Disorder of Sex Development, 46,XY
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn