Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

This study is currently recruiting participants.

Verified February 2013 by Massachusetts General Hospital

Sponsor:

Information provided by (Responsible Party):

Stephanie B. Seminara, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01438073

First received: August 24, 2011

Last updated: February 11, 2013

Last verified: February 2013

History of Changes

Purpose

The investigators are seeking subjects for a study of the role of kisspeptin in the reproductive system. Kisspeptin is a naturally occurring hormone in humans that stimulates the production of reproductive hormones. Continuous administration of kisspeptin paradoxically suppresses the reproductive endocrine axis temporarily. By administering 24-hour infusions of kisspeptin, the investigators hope to learn more about the role of kisspeptin both in normal physiology and pathological conditions.

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 reproductive disorders. Study participation involves 2 outpatient visits and one 38-hour hospital admission when subjects will receive kisspeptin. Individuals interested in learning more may call 617-724-8592.

Condition	Intervention	Phase
Hypogonadotropic Hypogonadism	Drug: kisspeptin 112-121	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Elucidating Kisspeptin Physiology by Blocking Kisspeptin Signaling

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Luteinizing hormone (LH) level [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Follicle stimulating hormone (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 ]
Complete blood count (CBC) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Blood urea nitrogen (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:	156
Study Start Date:	September 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: kisspeptin 24-hour continuous intravenous infusion of kisspeptin 112-121 12.5 µg/kg/h	Drug: kisspeptin 112-121 24-h continuous intravenous infusion of kisspeptin 112-121 12.5 µg/kg/h Other Name: metastin 45-54

Detailed Description:

Please contact study staff for a detailed description.

Eligibility

Ages Eligible for Study:	21 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

age 21-40 years (healthy men and regularly cycling women) OR age 50-60 years (healthy postmenopausal women)
Body mass index (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
white blood cell count (WBC), platelets, prolactin, and thyroid stimulating hormone (TSH) within 90%-110% of laboratory reference range
blood urea nitrogen (BUN) and creatinine not elevated
normal luteinizing hormone (LH), follicle stimulating hormone (FSH), testosterone (men), estradiol (women)
liver function tests less than 2x upper limit of normal
for cycling women, regular menstrual cycles 25-35 days in duration
for postmenopausal women, no menstrual periods within the last year
for women, negative serum human chorionic gonadotropin (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 therapy 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)
breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438073

Contacts

Contact: Valerie Sidhoum, BA

617-724-8592

vsidhoum@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

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:	NCT01438073 History of Changes
Other Study ID Numbers:	2011-P-001564
Study First Received:	August 24, 2011
Last Updated:	February 11, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypogonadism
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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