Administration of Kisspeptin to Healthy Subjects and Subjects With Reproductive Disorders - Full Text View

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00914823

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 initially seeking healthy men and healthy women with regular menstrual cycles. In a later part of the study, the investigators will also enroll subjects with delayed puberty and other reproductive disorders. Study participation involves 2 outpatient visits and one 14-hour hospital admission when subjects will receive kisspeptin. Remuneration is $400 for study completion. Individuals interested in learning more may call 617-726-8300.

Condition	Intervention	Phase
Healthy Hypogonadotropic Hypogonadism	Drug: kisspeptin 112-121	Phase I

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Administration of Kisspeptin 112-121 to Healthy Subjects and Subjects With Hypogonadotropic Hypogonadism

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 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
kisspeptin: Experimental intravenous administration of kisspeptin 112-121 0.24 nmol/kg	Drug: kisspeptin 112-121 single intravenous dose of kisspeptin 112-121 0.24 nmol/kg

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 a pilot study to assess the effects of kisspeptin administered as single intravenous bolus, first in healthy subjects, then in subjects with hypogonadotropic hypogonadism.

Eligibility

Ages Eligible for Study:	21 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

age 21-40 years
BMI 18.5-30 kg/m2
history of normal puberty with respect to onset and pace
systolic blood pressure <140 mm Hg, diastolic blood pressure <90 mm Hg
normal complete blood count, BUN, creatinine, TSH, LH, FSH, testosterone (men), estradiol (women)
liver function tests less than 2x upper limit of normal
prolactin <15 ng/mL
for women, regular menstrual cycles 25-35 days in duration
for women, negative serum hCG pregnancy test at the time of screening and negative urine hCG pregnancy test at the time of drug administration
for men, normal erectile and ejaculatory function by report, and no history of reproductive disorders (e.g., cryptorchidism)
for men, testicular volume 15 mL or greater by Prader orchidometer

Exclusion Criteria:

use of prescription medications in prior 2 months (with the exception of seasonal allergy medications)
illicit drug use
consumption of more than 10 alcoholic drinks per week
history of anaphylactic reactions
history of chronic disease
for women, use of hormonal contraception in prior 2 months
for women, lack of access of non-hormonal contraception if sexually active with a male partner
for women, evidence of androgen excess (e.g., hirsutism or acne)

Contacts and Locations

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

Contacts

Contact: Stephanie B. Seminara, MD

617-724-8304

seminara.stephanie@mgh.harvard.edu

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

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Stephanie B. Seminara, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( Stephanie B. Seminara, MD/Associate in Medicine )
Study ID Numbers:	2008-P-002486
Study First Received:	June 4, 2009
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00914823 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

healthy subjects

Study placed in the following topic categories:

Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Endocrinopathy
Healthy

Additional relevant MeSH terms:

Hypogonadism
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 03, 2009