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

June 4, 2009
July 7, 2014
March 2009
December 2016   (final data collection date for primary outcome measure)
LH level [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00914823 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Administration of Kisspeptin to Subjects With Reproductive Disorders
Kisspeptin Administration in the Adult

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Hypogonadotropic Hypogonadism
  • Kallmann Syndrome
  • GnRH Deficiency
  • PCOS
  • Polycystic Ovarian Syndrome
  • 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
Experimental: kisspeptin, GnRH
intravenous administration of kisspeptin 112-121 and/or GnRH
Interventions:
  • Drug: kisspeptin 112-121
  • Drug: GnRH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2016
December 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Voula Christopoulos, PA 617-724-8592 vchristopoulos@partners.org
United States
 
NCT00914823
2008-P-002486
Yes
Stephanie B. Seminara, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Stephanie B. Seminara, MD Massachusetts General Hospital
Massachusetts General Hospital
July 2014

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