Administration of Kisspeptin to Subjects With Reproductive Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Stephanie B. Seminara, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00914823
First received: June 4, 2009
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

The investigators are seeking subjects 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 investigators are seeking men and women with hypogonadotropic hypogonadism (HH) and women with PCOS. Study participation involves 1-2 outpatient visits and 1-2 12-14-hour hospital admission(s) when subjects will receive kisspeptin and/or gonadotropin-releasing hormone (GnRH). Remuneration is up to $800 for study completion. Individuals interested in learning more may call 617-724-1083.


Condition Intervention Phase
Hypogonadotropic Hypogonadism
Kallmann Syndrome
GnRH Deficiency
PCOS
Polycystic Ovarian Syndrome
Drug: kisspeptin 112-121
Drug: GnRH
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Kisspeptin Administration in the Adult

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • LH level [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FSH levels [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • testosterone (males) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • estradiol (females) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • CBC [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • BUN [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • creatinine [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • liver function studies [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, 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

Detailed Description:

The master reproductive hormone GnRH (gonadotropin-releasing hormone) is essential for normal reproductive function. Individuals who fail to secrete or respond to GnRH have a condition called hypogonadotropic hypogonadism. These individuals fail to undergo puberty and are infertile. Study of these patients has led to better understanding of the reproductive endocrine system.

Kisspeptin is a peptide hormone that has recently been found to be a potent stimulus for GnRH release. This hormone has several potential applications:

  • in research settings, administration of kisspeptin may be used to characterize the precise defect in subjects with hypogonadotropic hypogonadism and, in turn, may lead to better understanding of the reproductive endocrine system
  • kisspeptin may have diagnostic applications in the evaluation of delayed puberty and infertility
  • kisspeptin may have applications in the treatment of reproductive disorders such as infertility and irregular or absent menstrual periods

This study is to assess the effects of kisspeptin administered in subjects with hypogonadotropic hypogonadism and subjects with PCOS.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • systolic blood pressure <140 mm Hg, diastolic blood pressure <90 mm Hg
  • normal ferritin/iron binding studies (ruling out hemochromatosis)
  • white blood cell (WBC), platelet counts, prolactin, and thyroid stimulating hormone (TSH) between 90% of the lower limit and 110% of the upper limit of the reference range
  • hemoglobin:

    1. women: no less than 0.5 gm/dL below the lower limit of the reference range for normal women
    2. men: Within normal male reference range if on adequate testosterone replacement therapy; no less than 0.5 gm/dL below the lower limit of the reference range for normal women if off testosterone replacement therapy, as men with hypogonadism have low serum testosterone levels which causes hemoglobin concentrations to fall to the female range
  • blood urea nitrogen (BUN), creatinine, liver function tests not elevated
  • for women, negative serum hCG pregnancy test at the time of screening and negative urine hCG pregnancy test at the time of drug administration

Exclusion Criteria:

  • use of prescription medications known to affect reproductive endocrine function for at least 2 months
  • illicit drug use
  • consumption of more than 10 alcoholic drinks per week
  • history of anaphylactic reactions
  • history of chronic disease, or all medical conditions stable and well controlled
  • currently seeking fertility
  • for women, lack of access of non-hormonal contraception if sexually active with a male partner
  • for women, breastfeeding or pregnant

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, and LH.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914823

Contacts
Contact: Voula Christopoulos, PA 617-724-8592 vchristopoulos@partners.org

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

No publications provided

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
Study First Received: June 4, 2009
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypogonadism
Polycystic Ovary Syndrome
Kallmann Syndrome
Gonadal Disorders
Endocrine System Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
46, XY Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 28, 2014