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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 19, 2017
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.

The investigators are seeking men and women with hypogonadotropic hypogonadism (HH) and hyperprolactinemia, as well as women with PCOS. Study participation involves 1 to 2 outpatient visits and 1 to 2, 3-15-hour hospital admission(s) where participants will receive kisspeptin and/or gonadotropin-releasing hormone (GnRH) through an intravenous line (IV). Remuneration is up to $800 for study completion. Individuals interested in learning more may email MGHKisspeptinResearch@partners.org or call 617-726-5383.

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 2020
Estimated Study Completion Date : December 2020

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. LH level [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. FSH levels [ Time Frame: 6 hours ]
  2. testosterone (males) [ Time Frame: 6 hours ]
  3. estradiol (females) [ Time Frame: 6 hours ]
  4. CBC [ Time Frame: 1 month ]
  5. BUN [ Time Frame: 1 month ]
  6. creatinine [ Time Frame: 1 month ]
  7. liver function studies [ Time Frame: 1 month ]
  8. Prolactin levels [ Time Frame: 1 month ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 or for 5 half-lives of the drug (whichever is shorter) 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,
  • no excessive alcohol consumption (<10 drinks/week),
  • not currently seeking fertility,
  • for women, not breastfeeding and not pregnant,
  • if applicable, able to undergo appropriate washout from hormone therapy.

Physical Examination:

- normal blood pressure, (systolic BP < 140 mm Hg, diastolic < 90 mm Hg).

Laboratory Studies:

  • white blood cell, platelet counts, and TSH between 90% of the lower limit and 110% of the upper limit of the reference range,
  • prolactin below 110% of the upper limit of the reference range with the exception of participants with hyperprolactinemia who by definition will have elevated levels of prolactin.
  • hemoglobin

    1. women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women,
    2. men:

    i. on adequate testosterone replacement therapy: normal male reference range, ii.off testosterone replacement therapy: no lower than 0.5 gm/dL below the lower limit of the reference range for normal women (> 11.5 gm/dL in our laboratory), as men with hypogonadism off treatment have low serum testosterone levels which causes hemoglobin concentrations to fall to the female range,

  • BUN, creatinine, AST, ALT not elevated,
  • for women, negative serum hCG pregnancy test at the time of screening (additional urine pregnancy test will be conducted prior to drug administration).

Additional criteria based on subject population:

  1. Men and women with hypogonadotropic hypogonadism: All subjects will have confirmed diagnosis by low sex steroids in the setting of low or inappropriately normal gonadotropins. If needed to verify clinical criteria, additional diagnostic labs and imaging tests may be performed including but not limited to ferritin, prolactin, sex steroids, FSH, LH and brain MRI.
  2. Women with Polycystic Ovarian Syndrome (PCOS): All subjects will have a confirmed diagnosis of PCOS as evidenced by 2 or more of the following: oligoamenorrhea, clinical or biochemical hyperandrogenism, and polycystic ovarian morphology, and exclusion of identifiable conditions that would result in this pattern. If needed to verify clinical criteria, additional diagnostic labs may be drawn including but not limited to 17-OHP, sex steroids, FSH, LH.
  3. Men and women with hyperprolactinemia: All subjects will have confirmed diagnosis by elevated levels of prolactin measured via blood test and MRI imaging confirming no pituitary abnormality or a microprolactinoma (<10 mm). Patients with a macroprolactinoma will be excluded. We will enroll subjects when they first present with hyperprolactinemia prior to receiving medication or subjects being treated with the dopamine agonist bromocriptine only. We will ask subjects being treated with bromocriptine to complete a washout period prior to the kisspeptin administration visit(s). The washout period will last at least 2 weeks. We will perform a blood test prior to the kisspeptin administration visit(s) to confirm elevated levels of prolactin.

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

Contact: Addie Davies 617-724-8764 MGHKisspeptinResearch@partners.org

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephanie B. Seminara, MD, Associate in Medicine, 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 19, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Kallmann Syndrome
Polycystic Ovary Syndrome
Pathologic Processes
Gonadal Disorders
Endocrine System Diseases
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
46, XY Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn